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    Unser Klient ist eins der grössten Unternehmen in Deutschland. Das Krankenhaus ist ein Maximalversorger mit modernste Medizin und mit einen Platz wo Patienten schnell wieder gesund sind.

    Das Haus arbeitet interdisziplinär mit dem Viszeral-onkologisches Zentrum sowie mit der Viszeralchirurgie und bietet u.a. die folgenden Leistungen an:

    • Diagnostische und therapeutische Endoskopie
    • Gastroenterologie
    • Sonografie
    • Innere Medizin und Infektiologie
    • Funktionsdiagnostik

    Wir suchen einen Kandidaten mit dem Profil:

    • FA für Innere Medizin mit Schwerpunkt Gastroenterologie
    • Solider klinischer und internistischer Erfahrung
    • Gute Kenntnisse in der interventionellen Endoskopie
    • Gute Kenntnisse in der Sonographie ist von Vorteil

    Ihre Aufgaben:

    • Betreuung der Patienten auf der gastroenterologischen Station
    • Betreuung von Patienten mit gastroenterologischen Fragestellungen des ganzen Hauses im Zentrum für Ultraschalldiagnostik und interventionelle Endoskopie
    • Teilnahme am Endoskopie-Rufdienst wird vorausgesetz

    Ihre Vorteile:

    • Ausssertarifliche Vergütung
    • Finanzierte (Digitale-) Fort- und Weiterbildungsmöglichkeiten
    • Zusatzversicherung mit Wahl/- Chefarztbehandlung und Wahlleistung
    • Kinderbetreuungsmöglichkeiten (eigene oder koop. KiTa)
    • Betriebliches Gesundheitsmanagement

    Sollte diese Stelle für Sie von Interesse sein, dann freuen wir uns auf ihre Kontaktaufnahme bei Frau Jessica Demirtas, Recruitment & Consultant DACH: Tel. 0041 43 508 73 11 oder per E-Mail: jessica.d.a4lgdx1grlwv@SkillsAlliance.aptrack.co

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (post marketing) appointment.

    This opportunity will position you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Director you will be a key stakeholder in the company’s regulatory activities and oversee the activities of product development and life cycle management for established products. You will be liasing with authorites globally to market products. As Director of Regulatory Affairs you will manage worldwide interactions and negotiations with stakeholders, agencies and partners to ensure continuity of supply. Strong leadership and strategic implementation is a key focus for this role.

    You will be responsible for managing partnerships from a regulatory standpoint for products/projects and the review and approval of labelling for the company’s products. You must have strong experience with documentation in support of commercial products (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety) and ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects.

    As Director you will oversee direct reports in preparation and management of above responsibilities and assist as needed. This exciting role requires you to have a deep and broad knowledge of regulatory affairs and direct experience with biological and/or pharmaceutical regulatory submissions and product approvals. You must have a proven track record of effective collaboration with regulatory agencies knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format as well as experience in preparation of global regulatory strategies

    A proven record of maintenance of regulatory authorizations and variations in at least two regions and supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODPMJ

  • UK

    £50000 - £60000 per annum, Benefits
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    Senior Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to lead the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Manager you will be the EU Regulatory Lead for an early phase compound. The Senior Manager will have important input in supporting European regulatory activities for Orphan diseases. You will be involved in supporting European regulatory activities for an innovative rare diseases pipeline. The Senior Manager will have the opportunity to contribute to innovative global regulatory strategies as well as be involved in US regulatory activities.

    Leading the design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global cross-functional Project Teams in the UK, US and Japan will be part of the role. Involvement in post-approval work for Centralised products may also be involved.

    As a Senior Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neurosciences therapy area is desirable. You will need prior experience in the resolution of regulatory risks as well as experience in submissions of CTA/MAA. Life cycle management and interfacing with regulatory authorities. All the above will be part of this diverse and exciting role. The Senior Manager will be influential with the financial budget, matrix and team. Strategic experience and forward thinking, cognitive capabilities as well as great organisational and problem-solving skills are required. A BSc/MSc relevant to the role is desired.

    This Senior Manager NBG Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMNBG

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    Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to support the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Manager you will be involved in supporting the European Regulatory activities for an orphan disease pipeline. You will contribute to innovative global regulatory strategies and have opportunities for involvement in US regulatory activities.

    The appointed person will also be the EU Regulatory Lead for an early phase compound, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for both above. Involvement in post-approval work for Centralised products may also be involved.

    As a Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neuroscience therapy areas is desirable. Experience with EU and/or UK regulatory processes and environment, including clinical trials, Regulatory strategy experience and strong strategic thinking skills are needed. As Manager, NBG you will be liaising and negotiating with regulatory authorities, both verbally and in writing. You must be able to operate in a complex environment and adapt well. You will need prior experience in submissions of CTA/MAA. Life cycle management.

    This is a diverse and exciting role that requires an experienced and forward-thinking individual. Strong organisational and problem-solving skills and a BSc/MSc relevant to the role is desired.

    The Manager, NBG Regulatory role is an office-based position with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

  • £90000 - £110000 per annum, Benefits
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    Director, Regulatory Affairs

    A global biopharmaceutical company developing life-changing medicines is recruiting for a Director of Regulatory Affairs in Oxford, United Kingdom.

    This is an opportunity to be a key stakeholder in the companies’ Regulatory activities. This global biopharmaceutical is passionate about developing meaningful medicines, bringing them to people with unaddressed needs around the world. As Director you will play a key role in seeking solutions for rare or complex diseases, and ensuring solutions are available for the often-overlooked patients in need.

    As Director your role will be to initiative and oversee regulatory activities of product development and life cycle management for licensed products. You will support the company’s efforts to obtain and maintain agreements with Health Authorities globally to market products. The Director of Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. As a key member you may also be leading project teams while also overseeing junior regulatory team members.

    Essential Functions

    • Manage partnerships from regulatory standpoint for products/projects
    • Review and approve labelling for the company’s products
    • Review documentation in support of commercial product (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety)
    • Ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects

    Required Knowledge, Skills, and Abilities

    • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
    • Knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format
    • Experience in preparation of global regulatory strategies
    • Experience with maintenance of regulatory authorizations and variations in at least two regions
    • Experience with supporting a project with development activities in at least two regions
    • Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions

    Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry is desirable.

    As Director you will be provided with an incredibly competitive salary and flexible home/office based working hours.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IODJ

  • £65000 - £75000 per annum, + Benefits
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    Global Labelling, Associate Director

    A fantastic opportunity to join an innovative pharma company that is recruiting for an Associate Director for Global Labelling.

    This opportunity will allow for collaborative input making a real difference in the lives of patients and the life sciences. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You will be responsible for the packaging and labelling of pharmaceutical products in accordance with regulations; principally the information printed on the outward packaging and inner leaflet, containing important safety information and any adverse effects.

    Typical day-to-day responsibilities will be authoring PILs and SmPCs. You will also be responsible for updating label information according to health authorities, reviewing documentation and updating the company’s core data sheet.

    They require an experienced professional with Regulatory and Health Authority experience. You will need to understand the artwork, labelling, submissions and variations for different markets. Line management may be required at a later stage. Medical writers are also encouraged to apply. The company is open to an individual with strong knowledge in the area who is looking for the next step in their career.

    This Associate Director of Global Labelling is an office-based position within greater London. This is a fantastic permanent opportunity offering a competitive salary and package.
    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOGLADE

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

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    Senior Manager, Regulatory Affairs

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs, Growth Markets in the Hertfordshire area.

    This fantastic opportunity will allow you to attend appropriate scientific and medical courses all provided to help advance your skills. Offering an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior manager of growth markets you will apply broad knowledge and interpretation of regulatory requirements in growth markets for the company products to the drug development process. This includes the promulgation of health authority marketing dossiers to enable efficient registration of medicinal products consistent with the supported regions commericial objectives. As manager you will ensure that regulatory documentation meets relevant regulatory requirments and quality standards.

    You will also have opportunity to direct the activity of a work team project within the department and may have responsibility for management of highly skilled professional employees.

    The Senior manager of growth markets opportunity is an office-based position in the Hertfordshire area. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMGME

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    The Deputy EU QPPV and Deputy Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking The Deputy EU QPPV and Deputy Head of Drug Safety International.

    The Deputy EU QPPV and Deputy Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • M.D Degree
    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • UK

    £65000 - £75000 per annum, Benefits
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    Senior Safety Evaluation Physician

    An innovative and patient focused pharma company is recruiting for a Senior Safety Evaluation Physician in the Hertfordshire area.

    This fantastic opportunity will allow you to attend appropriate scientific and medical courses all provided to help advance your skills. Offering an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Safety Evaluation Physician you will support the Head of Safety Evaluation, the Qualified Person for Pharmacovigilance (EU QPPV) and the global safety community, in the provision of a comprehensive Pharmacovigilance and Product Safety service internationally and in Europe.

    You will also have opportunity for close interactions with other members of the drug safety community, including safety affiliates and the corporate office.

    They require you to hold a UK GMC-approved or similar medical registration and have demonstrated experience in post-registration clinical medicine.

    This role includes but is not limited to leading the response to safety-related medical queries from regulatory authorities, external bodies and internally for specified product

    As General Safety Officer (GSO) for an assigned group of products, you will support the collection, assessment, evaluation, distribution and reporting of individual and cumulative safety reports.

    The Senior Safety Evaluation Physician will have acquired previous experience in pharmacovigilance during which a consistent record of strong contribution has been demonstrated, in addition to success in tackling new challenges and responsibilities.

    This Senior Safety Evaluation Physician opportunity is an office-based position in the Hertfordshire area. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSSEP

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs (New products)

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (New Products) appointment.

    This positions you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.
    As Director you will be a key stakeholder in the company’s regulatory activities focusing efforts to obtain worldwide approvals to market products.

    The Director, Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. Strong leadership skills and strategic implementation is a key focus for this role.

    As Director you will have had experience resolving complex issues in creative and effective ways. Supervising activities that include planning and co-ordination of the writing and reviewing of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).

    You will ensure the internal review and submission of these items have been appropriately managed, providing an in-depth reviews of Review of protocols, Investigator Brochures, IND/IMPDs, reports quality, safety, efficacy and labelling) including CTAs, anticipating internal and/or external business challenges and/or regulatory issues will be required.

    As Director you will work with Global Regulatory Lead to support regulatory budget and resource needs for molecule assessing the resource requirement to support molecule strategic objectives.
    You will be xperienced in maintenaning regulatory authorizations in at least one region and experience with supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODNPJ

  • £80000 - £95000 per annum, Benefits
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    Associate Director, Global CMC

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for an Associate Director of Regulatory Affairs, Global CMC.

    The Associate Director position, Global CMC will be responsible for managing, leading registration and providing CMC regulatory support for commercial and development projects worldwide with a bio pharma that has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Associate Director, CMC you will be responnsible for the planning and co-ordination of writing and reviewing Module 2 and 3 CTD sections for all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). You will lead functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, late and early stage development programs. Solve unique and complex problems that have a broad impact on the function and/or broader department.

    As Associate Director you will provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues
    You will be required to regularly interact with functional leaders and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.

    As Associte Director you will be experienced in identifying and leading for continuous improvement opportunities for the GRA-CMC team and the broader GRA team. In addition to this you must monitor EU and US CMC regulations assessing any changes to ensure all development activities are in compliance with applicable current regulations and guidelines. Experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs). In depth knowledge of FDA, EMA and ICH guidelines is also required.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOADCMCJ

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    Senior Manager, Regulatory Affairs

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs, Growth Markets in the Hertfordshire area.

    This fantastic opportunity will allow you to attend appropriate scientific and medical courses all provided to help advance your skills. Offering an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior manager of growth markets you will apply broad knowledge and interpretation of regulatory requirements in growth markets for the company products to the drug development process. This includes the promulgation of health authority marketing dossiers to enable efficient registration of medicinal products consistent with the supported regions commericial objectives. As manager you will ensure that regulatory documentation meets relevant regulatory requirments and quality standards.

    You will also have opportunity to direct the activity of a work team project within the department and may have responsibility for management of highly skilled professional employees.

    The Senior manager of growth markets opportunity is an office-based position in the Hertfordshire area. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMGME

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs (New products)

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (New Products) appointment.

    This positions you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.
    As Director you will be a key stakeholder in the company’s regulatory activities focusing efforts to obtain worldwide approvals to market products.

    The Director, Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. Strong leadership skills and strategic implementation is a key focus for this role.

    As Director you will have had experience resolving complex issues in creative and effective ways. Supervising activities that include planning and co-ordination of the writing and reviewing of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).

    You will ensure the internal review and submission of these items have been appropriately managed, providing an in-depth reviews of Review of protocols, Investigator Brochures, IND/IMPDs, reports quality, safety, efficacy and labelling) including CTAs, anticipating internal and/or external business challenges and/or regulatory issues will be required.

    As Director you will work with Global Regulatory Lead to support regulatory budget and resource needs for molecule assessing the resource requirement to support molecule strategic objectives.
    You will be xperienced in maintenaning regulatory authorizations in at least one region and experience with supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODNPJ

  • UK

    £65000 - £75000 per annum, Benefits
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    Senior Safety Evaluation Physician

    An innovative and patient focused pharma company is recruiting for a Senior Safety Evaluation Physician in the Hertfordshire area.

    This fantastic opportunity will allow you to attend appropriate scientific and medical courses all provided to help advance your skills. Offering an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Safety Evaluation Physician you will support the Head of Safety Evaluation, the Qualified Person for Pharmacovigilance (EU QPPV) and the global safety community, in the provision of a comprehensive Pharmacovigilance and Product Safety service internationally and in Europe.

    You will also have opportunity for close interactions with other members of the drug safety community, including safety affiliates and the corporate office.

    They require you to hold a UK GMC-approved or similar medical registration and have demonstrated experience in post-registration clinical medicine.

    This role includes but is not limited to leading the response to safety-related medical queries from regulatory authorities, external bodies and internally for specified product

    As General Safety Officer (GSO) for an assigned group of products, you will support the collection, assessment, evaluation, distribution and reporting of individual and cumulative safety reports.

    The Senior Safety Evaluation Physician will have acquired previous experience in pharmacovigilance during which a consistent record of strong contribution has been demonstrated, in addition to success in tackling new challenges and responsibilities.

    This Senior Safety Evaluation Physician opportunity is an office-based position in the Hertfordshire area. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSSEP

  • £80000 - £95000 per annum, Benefits
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    Associate Director, Global CMC

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for an Associate Director of Regulatory Affairs, Global CMC.

    The Associate Director position, Global CMC will be responsible for managing, leading registration and providing CMC regulatory support for commercial and development projects worldwide with a bio pharma that has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Associate Director, CMC you will be responnsible for the planning and co-ordination of writing and reviewing Module 2 and 3 CTD sections for all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). You will lead functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, late and early stage development programs. Solve unique and complex problems that have a broad impact on the function and/or broader department.

    As Associate Director you will provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues
    You will be required to regularly interact with functional leaders and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.

    As Associte Director you will be experienced in identifying and leading for continuous improvement opportunities for the GRA-CMC team and the broader GRA team. In addition to this you must monitor EU and US CMC regulations assessing any changes to ensure all development activities are in compliance with applicable current regulations and guidelines. Experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs). In depth knowledge of FDA, EMA and ICH guidelines is also required.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOADCMCJ

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    The Deputy EU QPPV and Deputy Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking The Deputy EU QPPV and Deputy Head of Drug Safety International.

    The Deputy EU QPPV and Deputy Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • M.D Degree
    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

  • £65000 - £75000 per annum, + Benefits
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    Global Labelling, Associate Director

    A fantastic opportunity to join an innovative pharma company that is recruiting for an Associate Director for Global Labelling.

    This opportunity will allow for collaborative input making a real difference in the lives of patients and the life sciences. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You will be responsible for the packaging and labelling of pharmaceutical products in accordance with regulations; principally the information printed on the outward packaging and inner leaflet, containing important safety information and any adverse effects.

    Typical day-to-day responsibilities will be authoring PILs and SmPCs. You will also be responsible for updating label information according to health authorities, reviewing documentation and updating the company’s core data sheet.

    They require an experienced professional with Regulatory and Health Authority experience. You will need to understand the artwork, labelling, submissions and variations for different markets. Line management may be required at a later stage. Medical writers are also encouraged to apply. The company is open to an individual with strong knowledge in the area who is looking for the next step in their career.

    This Associate Director of Global Labelling is an office-based position within greater London. This is a fantastic permanent opportunity offering a competitive salary and package.
    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOGLADE

  • £90000 - £110000 per annum, Benefits
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    Director, Regulatory Affairs

    A global biopharmaceutical company developing life-changing medicines is recruiting for a Director of Regulatory Affairs in Oxford, United Kingdom.

    This is an opportunity to be a key stakeholder in the companies’ Regulatory activities. This global biopharmaceutical is passionate about developing meaningful medicines, bringing them to people with unaddressed needs around the world. As Director you will play a key role in seeking solutions for rare or complex diseases, and ensuring solutions are available for the often-overlooked patients in need.

    As Director your role will be to initiative and oversee regulatory activities of product development and life cycle management for licensed products. You will support the company’s efforts to obtain and maintain agreements with Health Authorities globally to market products. The Director of Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. As a key member you may also be leading project teams while also overseeing junior regulatory team members.

    Essential Functions

    • Manage partnerships from regulatory standpoint for products/projects
    • Review and approve labelling for the company’s products
    • Review documentation in support of commercial product (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety)
    • Ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects

    Required Knowledge, Skills, and Abilities

    • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
    • Knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format
    • Experience in preparation of global regulatory strategies
    • Experience with maintenance of regulatory authorizations and variations in at least two regions
    • Experience with supporting a project with development activities in at least two regions
    • Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions

    Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry is desirable.

    As Director you will be provided with an incredibly competitive salary and flexible home/office based working hours.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IODJ

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    Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to support the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Manager you will be involved in supporting the European Regulatory activities for an orphan disease pipeline. You will contribute to innovative global regulatory strategies and have opportunities for involvement in US regulatory activities.

    The appointed person will also be the EU Regulatory Lead for an early phase compound, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for both above. Involvement in post-approval work for Centralised products may also be involved.

    As a Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neuroscience therapy areas is desirable. Experience with EU and/or UK regulatory processes and environment, including clinical trials, Regulatory strategy experience and strong strategic thinking skills are needed. As Manager, NBG you will be liaising and negotiating with regulatory authorities, both verbally and in writing. You must be able to operate in a complex environment and adapt well. You will need prior experience in submissions of CTA/MAA. Life cycle management.

    This is a diverse and exciting role that requires an experienced and forward-thinking individual. Strong organisational and problem-solving skills and a BSc/MSc relevant to the role is desired.

    The Manager, NBG Regulatory role is an office-based position with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (post marketing) appointment.

    This opportunity will position you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Director you will be a key stakeholder in the company’s regulatory activities and oversee the activities of product development and life cycle management for established products. You will be liasing with authorites globally to market products. As Director of Regulatory Affairs you will manage worldwide interactions and negotiations with stakeholders, agencies and partners to ensure continuity of supply. Strong leadership and strategic implementation is a key focus for this role.

    You will be responsible for managing partnerships from a regulatory standpoint for products/projects and the review and approval of labelling for the company’s products. You must have strong experience with documentation in support of commercial products (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety) and ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects.

    As Director you will oversee direct reports in preparation and management of above responsibilities and assist as needed. This exciting role requires you to have a deep and broad knowledge of regulatory affairs and direct experience with biological and/or pharmaceutical regulatory submissions and product approvals. You must have a proven track record of effective collaboration with regulatory agencies knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format as well as experience in preparation of global regulatory strategies

    A proven record of maintenance of regulatory authorizations and variations in at least two regions and supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODPMJ

  • UK

    £50000 - £60000 per annum, Benefits
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    Senior Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to lead the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Manager you will be the EU Regulatory Lead for an early phase compound. The Senior Manager will have important input in supporting European regulatory activities for Orphan diseases. You will be involved in supporting European regulatory activities for an innovative rare diseases pipeline. The Senior Manager will have the opportunity to contribute to innovative global regulatory strategies as well as be involved in US regulatory activities.

    Leading the design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global cross-functional Project Teams in the UK, US and Japan will be part of the role. Involvement in post-approval work for Centralised products may also be involved.

    As a Senior Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neurosciences therapy area is desirable. You will need prior experience in the resolution of regulatory risks as well as experience in submissions of CTA/MAA. Life cycle management and interfacing with regulatory authorities. All the above will be part of this diverse and exciting role. The Senior Manager will be influential with the financial budget, matrix and team. Strategic experience and forward thinking, cognitive capabilities as well as great organisational and problem-solving skills are required. A BSc/MSc relevant to the role is desired.

    This Senior Manager NBG Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMNBG

  • USA

    $100000 - $120000 per annum
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    This is an excellent opportunity to join one of the most exciting healthcare marketing agencies in New York area and the chance to work with the top pharmaceutical organizations.

    As the Scientific Communication director, you will become the subject matter expert in the publication space. The successful applicant will have the chance to have a leadership role and have an influential position in the organization.

    The applicant will have a rare opportunity to ensure scientific materials produced are of high quality and supported by current scientific thinking. In this role, you will ultimately maintain and build the scientific reputation of the company. You will be responsible for managing multiple accounts from a scientific perspective including publication plans and advisory boards. You will also engage in client interactions and meetings to demonstrate content. You will also write abstracts and manuscript outlines while gaining experience in managing freelance writers to projects.

    You must have a minimum of an advanced degree in biomedical sciences (PhD, MD or PharmD). Also, a minimum of 5 years of academic, pharmaceutical industry or agency experience. A background in multiple therapeutic areas and a strong personality would be looked at favorably.

    The company is one of the leading healthcare focused marketing and consulting agency. They are currently merging and creating more opportunity for growth and expansion. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8343.

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    A thriving company in Boston is looking for a Senior Manager – Clinical Supply. A product launch is expected very soon. Be part of a growing biotech! This is becoming one of the most desirable companies to work for. This is on site position with an ongoing contact.

    A Senior Manager, Clinical Supply has key responsibilities which include overseeing several global clinical trials, enlarging access programs, and Investigator Sponsored Trails (IST). In this role, you will work with the Clinical Supply Associate, Clinical Operations, and Quality Assurance. By doing this, you will grow clinical supply chains to be certain that clinical supplies are able to be obtained in a constant manner, and make sure they are ready to be viewed for an inspection. You can also be creative and think of ways the company and over excel.

    An undergraduate degree in Life Sciences is required. You must have anywhere between 5-12 years experience in clinical supply management, or experience in a pharmaceutical/biopharmaceutical setting. Desirable candidates will have experience in CMO management. This is not limited to assigning, wrapping, and administering in North America and Europe. One should also have experience with IRT system and execution. Have a basic understanding of cGMPS and FDA and EU Regulations. Get accustomed with global regulatory agencies and counseling.

    • CRO management experience
    • Clinical Supply
    • Regulatory knowledge
    • Global regulations knowledge
    • Monitor inventory levels
    • Manage packaging timelines

    If you are interested in learning more about this opportunity, please email me at alex.f.a4lgdx1groia@skillsalliance.aptrack.co

  • USA

    $150000 - $185000 per annum
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    A Global Research and Development organization has a pivotal hire to be made. This organization is looking for an Associate Director of Regulatory Affairs to join their team. The Associate Director would be acting as the strategist on a close-knit regulatory team. The Associate Director would report directly into the VP of the regulatory team and act as an individual contributor. As the Associate Director, you would responsible for all strategy focused tasks within this global organization including engagements with the FDA and other governing agencies. The Associate Director would be responsible for leading the IND strategies for this organization as well. The ideal candidate would have an advance degree like a PhD or Masters along with working knowledge of strategic matters for IND submissions. Ideally, the candidate would have engaged with the FDA on a couple accounts as well.

    The organization the Associate Director would be joining is partnered with one of the largest pharmaceutical companies in the world. This company functions as the R&D arm of this global company and has a robust pipeline of assets that cover multiple therapeutic areas. This gives the Associate Director the opportunity to lead multiple IND submissions in different therapeutic areas each year with the organization.

    For further consideration, please submit a copy or your resume.

  • USA

    $120000 - $140000 per annum
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    An innovative biopharmaceutical company is looking for a Program Manager (PM) in the greater Boston area to help with the planning and executing of programs. Their innovative plans for the discovery and development of novel therapeutics are to treat diseases caused by an imbalance of proteins and work with CF, genetic diseases and neurodegenerative diseases.

    Key Responsibilities:
    • Monitor the progress of programs and adjust as necessary with the Project Lead to ensure the successful completion of the program goals and objectives.
    • Work closely with the functional leads (i.e., SVP Clinical Development Operations) to update relevant stakeholders weekly on progress in all programs.
    • Lead project planning, develop and maintain timelines and coordinate deliverables in collaboration with program leads.
    • Collaborate with teams to support strategies through implementation for corporate goals
    • Responsible for confirming all department heads and all stakeholders are aligned with regards to each of the programs

    Qualifications:
    • B.S. / M.S., degree- preferably in Project Management
    • A minimum of 5 years (PM) experience in a biotech or related industry
    • Proficient with computer applications, Microsoft suite and MS Project
    • Able to learn and master other computer tech and software programs
    • Ability to work well with all levels of internal management and staff, as well as outside clients and vendors
    • Ability to work independently and in a team environment
    • Problem solving and strong communication skills a necessity

    Please contact Jen at alex.f.a4lgdx1groif@skillsalliance.aptrack.co for more information.

  • USA

    $160000 - $185000 per annum
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    An auto-immune focused biotherapeutic is looking for an experience Program Manager to join this unique organization. The company is in a great position as they have just entered first in human trials and are now looking to scale the business. This means that the company is looking to secure the key hires of the business and have the core group in place before they further scale the business. This Program Director would be working very closely with the Co-Founder and VP of Operations and executing the daily tasks of a Program Director.

    This Program Director would be responsible for managing a diverse amount of initiatives that are in the clinical and research and development space. The ideal candidate would have prior exposure in the research and development space, worked within the clinical operations space and has tremendous amount of experience acting as a project manager. There is great growth potential with this company as they start to scale and the Program Director can easily see themselves becoming a pillar within the business.

    If interested in learning more about the role please apply or contact Alex Fenyn at alex.f.a4lgdx1groij@skillsalliance.aptrack.co

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    A thriving company in Boston is looking for a Lead Clinical Research Associate. A product launch is expected very soon. This is an In-House CRA role, which means no traveling. This growing biotech is becoming one of the most desirable companies to work for.

    A desirable candidate will have key responsibilities which include overseeing clinical trials, communicate with the team of any discrepancies or site issues. The candidate will give clinical operations support to CTAs and CRAs.

    • Supervise and train other Clinical Research Associates
    • Must have 2+ years of experience in a pharmaceutical company, CRO, or similar organization
    • Pay close attention to aspects in constituting and revising
    • Strong knowledge of regulatory requirements
    • Analytical thinker
    • Understand GCP/ICH guidelines
    If you are interested in learning more about this opportunity, please email me at:

  • USA

    $145000 - $170000 per annum
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    This is an excellent opportunity to join one of the most exciting pharmaceutical companies in the Greater Boston area with a recent approved cancer therapeutic offering rapid career progression.

    As the Senior Manager Analytics & Reporting, you will be responsible for completing data analyses to support the commercial operations team for this ground-breaking product. They are exponentially growing, which gives you the opportunity to influence the success of the company with your contributions.

    Reporting directly into the VP of Commercial Operations, the applicant will have a rare opportunity to lead all business insight for commercial operations. In this role, you will be responsible for utilizing tools for reporting, data collection, and analytics. This will include collaborating with field sales and marketing teams, as well as market access.

    You must have a minimum of a bachelor’s degree and a minimum of five years of experience in analytics preferably in oncology or biotechnology industries. An advanced knowledge of Qlik, Tableau, Microsoft Power BI, and BI Applications is required.

    The company is one of the most unique in the industry with a proven track record of success both domestic and abroad in the oncology space. In addition to their recently approved cancer therapeutic, they have many other products at various stages from early to launched. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8343 or alex.f.a4lgdx1groin@skillsalliance.aptrack.co

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    A biopharmaceutical organization in the Greater Boston Area is looking to bring on a F/T Senior Manager, Analytics & Reporting to join their Commercial Operations team. The company is focused on the discovery and development of drugs to better improve the survival and quality of life for cancer patients. With 10 products in their pipeline; some of which are in the late stage of development, they are partnered by some of the biggest pharmaceutical organizations known. This is a great opportunity to join a growing organization and impact the lives of many.

    BASIC QUALIFICATIONS:

    • Advanced degree in IT, Business, Finance, Engineering or related discipline
    • Proven track record with 5+ years experience in analytics, database design & BI tools, sales operations or field sales.
  • USA

    $0 - $55 per hour
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    A thriving company in Boston is looking for a Clinical Trial Manager. A product launch is expected very soon. This growing biotech is becoming one of the most desirable companies to work for.

    We are looking for a candidate who can oversee operational parts of preparing and supervising performance to ensure departments are meeting standards.

    • Liaison between Clinical Research Associates (CRAs) and Project Managers (PMs)
    • Oversees CRA project meetings
    • Confirm that all sites have the necessary supplies to meet expectations
    • Work closely with CRAs to ensure compliance with procedure and guidelines
    • Must have 2+ years of experience in a pharmaceutical company, CRO, or similar organization
    • Strong knowledge of both computer and project management software

    If interested in learning more about this opportunity, please email me at: alex.f.a4lgdx1grpfi@skillsalliance.aptrack.co

  • USA

    $265000 - $325000 per annum
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    An emerging pharmaceutical company treating cognitive disorders and movement-related diseases is looking to bring on an individual to be their Head of Regulatory. This company is in a great position with multiple assets ranging from preclinical to Phase II. The science behind these novel therapies are unique as there are no drugs approved delivering treatments in the same way. Their goal with the assets is to effectively “rewire” brain to treat their ailments.

    As the Head of Regulatory Affairs, for this promising pharmaceutical company, you will be responsible for all strategy efforts and engagements with the FDA on a regular basis. The Head of Regulatory Affairs would also be responsible for operations components for their submissions. As the Head of Regulatory, you would be the subject matter expert for matrix teams and the organization as a whole. The ideal candidate for the Head of Regulatory would have experience filing INDs, NDAs, BLAs and Orphan Designation Applications. The candidate would ideally have exposure to Neurology products as well.

    If interested in learning more about this opportunity, please email me at: alex.f.a4lgdx1grpfk@skillsalliance.aptrack.co

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    The Deputy EU QPPV and Deputy Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking The Deputy EU QPPV and Deputy Head of Drug Safety International.

    The Deputy EU QPPV and Deputy Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • M.D Degree
    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • £80000 - £95000 per annum, Benefits
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    Associate Director, Global CMC

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for an Associate Director of Regulatory Affairs, Global CMC.

    The Associate Director position, Global CMC will be responsible for managing, leading registration and providing CMC regulatory support for commercial and development projects worldwide with a bio pharma that has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Associate Director, CMC you will be responnsible for the planning and co-ordination of writing and reviewing Module 2 and 3 CTD sections for all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). You will lead functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, late and early stage development programs. Solve unique and complex problems that have a broad impact on the function and/or broader department.

    As Associate Director you will provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues
    You will be required to regularly interact with functional leaders and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.

    As Associte Director you will be experienced in identifying and leading for continuous improvement opportunities for the GRA-CMC team and the broader GRA team. In addition to this you must monitor EU and US CMC regulations assessing any changes to ensure all development activities are in compliance with applicable current regulations and guidelines. Experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs). In depth knowledge of FDA, EMA and ICH guidelines is also required.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOADCMCJ

  • £90000 - £110000 per annum, Benefits
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    Director, Regulatory Affairs

    A global biopharmaceutical company developing life-changing medicines is recruiting for a Director of Regulatory Affairs in Oxford, United Kingdom.

    This is an opportunity to be a key stakeholder in the companies’ Regulatory activities. This global biopharmaceutical is passionate about developing meaningful medicines, bringing them to people with unaddressed needs around the world. As Director you will play a key role in seeking solutions for rare or complex diseases, and ensuring solutions are available for the often-overlooked patients in need.

    As Director your role will be to initiative and oversee regulatory activities of product development and life cycle management for licensed products. You will support the company’s efforts to obtain and maintain agreements with Health Authorities globally to market products. The Director of Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. As a key member you may also be leading project teams while also overseeing junior regulatory team members.

    Essential Functions

    • Manage partnerships from regulatory standpoint for products/projects
    • Review and approve labelling for the company’s products
    • Review documentation in support of commercial product (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety)
    • Ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects

    Required Knowledge, Skills, and Abilities

    • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
    • Knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format
    • Experience in preparation of global regulatory strategies
    • Experience with maintenance of regulatory authorizations and variations in at least two regions
    • Experience with supporting a project with development activities in at least two regions
    • Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions

    Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry is desirable.

    As Director you will be provided with an incredibly competitive salary and flexible home/office based working hours.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IODJ

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

  • £140000 - £150000 per annum, Benefits
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    The EU QPPV and Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking a EU QPPV and Head of Drug Safety International.

    The EU QPPV and Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • USA

    $265000 - $325000 per annum
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    Share

    An emerging pharmaceutical company treating cognitive disorders and movement-related diseases is looking to bring on an individual to be their Head of Regulatory. This company is in a great position with multiple assets ranging from preclinical to Phase II. The science behind these novel therapies are unique as there are no drugs approved delivering treatments in the same way. Their goal with the assets is to effectively “rewire” brain to treat their ailments.

    As the Head of Regulatory Affairs, for this promising pharmaceutical company, you will be responsible for all strategy efforts and engagements with the FDA on a regular basis. The Head of Regulatory Affairs would also be responsible for operations components for their submissions. As the Head of Regulatory, you would be the subject matter expert for matrix teams and the organization as a whole. The ideal candidate for the Head of Regulatory would have experience filing INDs, NDAs, BLAs and Orphan Designation Applications. The candidate would ideally have exposure to Neurology products as well.

    If interested in learning more about this opportunity, please apply directly via the “apply” button above.

  • USA

    $0 - $55 per hour
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    A thriving company in Boston is looking for a Clinical Trial Manager. A product launch is expected very soon. This growing biotech is becoming one of the most desirable companies to work for.

    We are looking for a candidate who can oversee operational parts of preparing and supervising performance to ensure departments are meeting standards.

    • Liaison between Clinical Research Associates (CRAs) and Project Managers (PMs)
    • Oversees CRA project meetings
    • Confirm that all sites have the necessary supplies to meet expectations
    • Work closely with CRAs to ensure compliance with procedure and guidelines
    • Must have 2+ years of experience in a pharmaceutical company, CRO, or similar organization
    • Strong knowledge of both computer and project management software

    If interested in learning more about this opportunity, please apply above

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    A biopharmaceutical organization in the Greater Boston Area is looking to bring on a F/T Senior Manager, Analytics & Reporting to join their Commercial Operations team. The company is focused on the discovery and development of drugs to better improve the survival and quality of life for cancer patients. With 10 products in their pipeline; some of which are in the late stage of development, they are partnered by some of the biggest pharmaceutical organizations known. This is a great opportunity to join a growing organization and impact the lives of many.

    BASIC QUALIFICATIONS:

    • Advanced degree in IT, Business, Finance, Engineering or related discipline
    • Proven track record with 5+ years experience in analytics, database design & BI tools, sales operations or field sales.
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    A thriving company in Boston is looking for a Lead Clinical Research Associate. A product launch is expected very soon. This is an In-House CRA role, which means no traveling. This growing biotech is becoming one of the most desirable companies to work for.

    A desirable candidate will have key responsibilities which include overseeing clinical trials, communicate with the team of any discrepancies or site issues. The candidate will give clinical operations support to CTAs and CRAs.

    • Supervise and train other Clinical Research Associates
    • Must have 2+ years of experience in a pharmaceutical company, CRO, or similar organization
    • Pay close attention to aspects in constituting and revising
    • Strong knowledge of regulatory requirements
    • Analytical thinker
    • Understand GCP/ICH guidelines

    If you are interested in learning more about this opportunity, please apply above

  • USA

    $160000 - $185000 per annum
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    An auto-immune focused biotherapeutic is looking for an experience Program Manager to join this unique organization. The company is in a great position as they have just entered first in human trials and are now looking to scale the business. This means that the company is looking to secure the key hires of the business and have the core group in place before they further scale the business. This Program Director would be working very closely with the Co-Founder and VP of Operations and executing the daily tasks of a Program Director.

    This Program Director would be responsible for managing a diverse amount of initiatives that are in the clinical and research and development space. The ideal candidate would have prior exposure in the research and development space, worked within the clinical operations space and has tremendous amount of experience acting as a project manager. There is great growth potential with this company as they start to scale and the Program Director can easily see themselves becoming a pillar within the business.

    If interested in learning more about the role please apply above

  • USA

    $120000 - $140000 per annum
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    An innovative biopharmaceutical company is looking for a Program Manager (PM) in the greater Boston area to help with the planning and executing of programs. Their innovative plans for the discovery and development of novel therapeutics are to treat diseases caused by an imbalance of proteins and work with CF, genetic diseases and neurodegenerative diseases.

    Key Responsibilities:
    • Monitor the progress of programs and adjust as necessary with the Project Lead to ensure the successful completion of the program goals and objectives.
    • Work closely with the functional leads (i.e., SVP Clinical Development Operations) to update relevant stakeholders weekly on progress in all programs.
    • Lead project planning, develop and maintain timelines and coordinate deliverables in collaboration with program leads.
    • Collaborate with teams to support strategies through implementation for corporate goals
    • Responsible for confirming all department heads and all stakeholders are aligned with regards to each of the programs

    Qualifications:
    • B.S. / M.S., degree- preferably in Project Management
    • A minimum of 5 years (PM) experience in a biotech or related industry
    • Proficient with computer applications, Microsoft suite and MS Project
    • Able to learn and master other computer tech and software programs
    • Ability to work well with all levels of internal management and staff, as well as outside clients and vendors
    • Ability to work independently and in a team environment
    • Problem solving and strong communication skills a necessity

    Please apply above if interested in learning more about the role.

  • USA

    $115000 - $130000 per annum
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    A globally known specialty pharmaceutical company in Richmond, VA is looking for PV Quality Audit Manager to join their company full time. Being a leader in the addiction/ pain management space they are fostering a culture of innovation and pioneering that better supports evidence- based treatments for addictions.

    The following key responsibilities of this role are to support strategic risk-based audit programs using a formal Risk Assessment Tool. Maintain consistent updates of the risk assessment tool for both internal and external processes. Publish approved audit plans to relevant departments internally. Create and maintain a Master List of approved PV providers alongside the Medical Compliance Manager to assess the risk of service carried out on behalf of the company.

    Qualifications:

    • Must be able to be on-site (great relocation package if you’re not currently in the Richmond, VA area)
    • Ability to travel regionally and internationally (20-40%)
    • Relevant degree in life science
    • Experience with Quality System auditing
    • Deep understanding of regulatory requirements and guidance that are relevant to PV (i.e Directives, publications ICH guidance)

    For more information please apply above.

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    A thriving company in Boston is looking for a Senior Manager – Clinical Supply. A product launch is expected very soon. Be part of a growing biotech! This is becoming one of the most desirable companies to work for. This is on site position with an ongoing contact.

    A Senior Manager, Clinical Supply has key responsibilities which include overseeing several global clinical trials, enlarging access programs, and Investigator Sponsored Trails (IST). In this role, you will work with the Clinical Supply Associate, Clinical Operations, and Quality Assurance. By doing this, you will grow clinical supply chains to be certain that clinical supplies are able to be obtained in a constant manner, and make sure they are ready to be viewed for an inspection. You can also be creative and think of ways the company and over excel.

    An undergraduate degree in Life Sciences is required. You must have anywhere between 5-12 years experience in clinical supply management, or experience in a pharmaceutical/biopharmaceutical setting. Desirable candidates will have experience in CMO management. This is not limited to assigning, wrapping, and administering in North America and Europe. One should also have experience with IRT system and execution. Have a basic understanding of cGMPS and FDA and EU Regulations. Get accustomed with global regulatory agencies and counseling.

    • CRO management experience
    • Clinical Supply
    • Regulatory knowledge
    • Global regulations knowledge
    • Monitor inventory levels
    • Manage packaging timelines

    If you are interested in learning more about this opportunity, please apply above.

  • USA

    $100000 - $120000 per annum
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    This is an excellent opportunity to join one of the most exciting healthcare marketing agencies in New York area and the chance to work with the top pharmaceutical organizations.

    As the Scientific Communication director, you will become the subject matter expert in the publication space. The successful applicant will have the chance to have a leadership role and have an influential position in the organization.

    The applicant will have a rare opportunity to ensure scientific materials produced are of high quality and supported by current scientific thinking. In this role, you will ultimately maintain and build the scientific reputation of the company. You will be responsible for managing multiple accounts from a scientific perspective including publication plans and advisory boards. You will also engage in client interactions and meetings to demonstrate content. You will also write abstracts and manuscript outlines while gaining experience in managing freelance writers to projects.

    You must have a minimum of an advanced degree in biomedical sciences (PhD, MD or PharmD). Also, a minimum of 5 years of academic, pharmaceutical industry or agency experience. A background in multiple therapeutic areas and a strong personality would be looked at favorably.

    The company is one of the leading healthcare focused marketing and consulting agency. They are currently merging and creating more opportunity for growth and expansion. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8343.

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    Pharmacovigilance Lead

    An international London based CRO is looking for a Pharmacovigilance Lead to join their expanding company. The role offers a fantastic opportunity to develop your skills across the spectrum of PV.

    As PV Project Lead you will be given the chance to work and develop your skills across a range of studies/projects and ensure deliverables are maintained to a high standard and carry out PV tasks on other studies/projects. You will have the opportunity to be involved in training PV Executives and mentor them.

    As PV lead you will have the opportunity to work alongside the Director of PV or PV Manager to strategically address any project concerns and assist the management team during audits and SOP generation.

    Main Responsibilities

    Act as primary point of contact on a project or a group of projects for internal and external clients.

    • Is responsible for set-up of a project from PV perspective:
    • Reviews the protocol and Investigator’s Brochure or other key project documents to develop a good understanding of the safety requirements.
    • Reviews the Work Order to ensure the Scope of Work and budget are consistent and escalate if necessary.
    • Takes part in Investigator Meeting or Site Initiation Visit, and delivers PV training, as request by the Project Manager and
    • Performs training to the rest of the PV team.
    • Prepares and finalizes Safety Management Plan, Reconciliation Plan, Narrative template, SAE and Pregnancy forms.
    • Registers the Sponsor or MAH in EudraVigilance and XEVMPD.
    • Configures the Safety Database with project details.
    • Prepares safety Trial Master File.
    • Verifies that the finance Unit and Revenue Forecast (URF) is consisted with the project scope and budget.
    • Ensures that the project or group of projects are managed effectively during maintenance phase:
    • Ensure all ICSRs and ESRs are processed and submitted on time.
    • Generate monthly line listing of SAEs and share it with the client.
    • Writes or provides support to all project Aggregate Reports.
    • Performs SAE Reconciliation as per the Reconciliation Plan.
    • Complete finance URF on time and accurately. Perform comparison with project timesheet to ensure logged time is consistent with the professional fees.
    • Maintain EudraVigilance and XEVMPD entry.
    • Manage Investigator’s Brochure throughout the lifetime of the project.
    • Maintain safety Trial Master File on an ongoing basis.
    • Identify process deviations and prepare CAPA in a timely manner.
    • Represents project during client or regulatory authority audits.

    This is a diversified opportunity that offers a breath of opportunity to grow and develop offering a competitive salary and benefits. It is an office-based role located in greater London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSOPV

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    Pharmacovigilance Lead

    An international London based CRO is looking for a Pharmacovigilance Lead to join their expanding company. The role offers a fantastic opportunity to develop your skills across the spectrum of PV.

    As PV Project Lead you will be given the chance to work and develop your skills across a range of studies/projects and ensure deliverables are maintained to a high standard and carry out PV tasks on other studies/projects. You will have the opportunity to be involved in training PV Executives and mentor them.

    As PV lead you will have the opportunity to work alongside the Director of PV or PV Manager to strategically address any project concerns and assist the management team during audits and SOP generation.

    Main Responsibilities

    Act as primary point of contact on a project or a group of projects for internal and external clients.

    • Is responsible for set-up of a project from PV perspective:
    • Reviews the protocol and Investigator’s Brochure or other key project documents to develop a good understanding of the safety requirements.
    • Reviews the Work Order to ensure the Scope of Work and budget are consistent and escalate if necessary.
    • Takes part in Investigator Meeting or Site Initiation Visit, and delivers PV training, as request by the Project Manager and
    • Performs training to the rest of the PV team.
    • Prepares and finalizes Safety Management Plan, Reconciliation Plan, Narrative template, SAE and Pregnancy forms.
    • Registers the Sponsor or MAH in EudraVigilance and XEVMPD.
    • Configures the Safety Database with project details.
    • Prepares safety Trial Master File.
    • Verifies that the finance Unit and Revenue Forecast (URF) is consisted with the project scope and budget.
    • Ensures that the project or group of projects are managed effectively during maintenance phase:
    • Ensure all ICSRs and ESRs are processed and submitted on time.
    • Generate monthly line listing of SAEs and share it with the client.
    • Writes or provides support to all project Aggregate Reports.
    • Performs SAE Reconciliation as per the Reconciliation Plan.
    • Complete finance URF on time and accurately. Perform comparison with project timesheet to ensure logged time is consistent with the professional fees.
    • Maintain EudraVigilance and XEVMPD entry.
    • Manage Investigator’s Brochure throughout the lifetime of the project.
    • Maintain safety Trial Master File on an ongoing basis.
    • Identify process deviations and prepare CAPA in a timely manner.
    • Represents project during client or regulatory authority audits.

    This is a diversified opportunity that offers a breath of opportunity to grow and develop offering a competitive salary and benefits. It is an office-based role located in greater London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSOPV

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

  • £140000 - £150000 per annum, Benefits
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    The EU QPPV and Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking a EU QPPV and Head of Drug Safety International.

    The EU QPPV and Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • £80000 - £95000 per annum, Benefits
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    Associate Director, Global CMC

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for an Associate Director of Regulatory Affairs, Global CMC.

    The Associate Director position, Global CMC will be responsible for managing, leading registration and providing CMC regulatory support for commercial and development projects worldwide with a bio pharma that has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Associate Director, CMC you will be responnsible for the planning and co-ordination of writing and reviewing Module 2 and 3 CTD sections for all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). You will lead functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, late and early stage development programs. Solve unique and complex problems that have a broad impact on the function and/or broader department.

    As Associate Director you will provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues
    You will be required to regularly interact with functional leaders and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.

    As Associte Director you will be experienced in identifying and leading for continuous improvement opportunities for the GRA-CMC team and the broader GRA team. In addition to this you must monitor EU and US CMC regulations assessing any changes to ensure all development activities are in compliance with applicable current regulations and guidelines. Experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs). In depth knowledge of FDA, EMA and ICH guidelines is also required.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOADCMCJ

  • £90000 - £110000 per annum, Benefits
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    Director, Regulatory Affairs

    A global biopharmaceutical company developing life-changing medicines is recruiting for a Director of Regulatory Affairs in Oxford, United Kingdom.

    This is an opportunity to be a key stakeholder in the companies’ Regulatory activities. This global biopharmaceutical is passionate about developing meaningful medicines, bringing them to people with unaddressed needs around the world. As Director you will play a key role in seeking solutions for rare or complex diseases, and ensuring solutions are available for the often-overlooked patients in need.

    As Director your role will be to initiative and oversee regulatory activities of product development and life cycle management for licensed products. You will support the company’s efforts to obtain and maintain agreements with Health Authorities globally to market products. The Director of Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. As a key member you may also be leading project teams while also overseeing junior regulatory team members.

    Essential Functions

    • Manage partnerships from regulatory standpoint for products/projects
    • Review and approve labelling for the company’s products
    • Review documentation in support of commercial product (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety)
    • Ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects

    Required Knowledge, Skills, and Abilities

    • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
    • Knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format
    • Experience in preparation of global regulatory strategies
    • Experience with maintenance of regulatory authorizations and variations in at least two regions
    • Experience with supporting a project with development activities in at least two regions
    • Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions

    Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry is desirable.

    As Director you will be provided with an incredibly competitive salary and flexible home/office based working hours.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IODJ

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    The Deputy EU QPPV and Deputy Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking The Deputy EU QPPV and Deputy Head of Drug Safety International.

    The Deputy EU QPPV and Deputy Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • M.D Degree
    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • UK

    £50000 - £60000 per annum, Benefits
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    Senior Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to lead the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Manager you will be the EU Regulatory Lead for an early phase compound. The Senior Manager will have important input in supporting European regulatory activities for Orphan diseases. You will be involved in supporting European regulatory activities for an innovative rare diseases pipeline. The Senior Manager will have the opportunity to contribute to innovative global regulatory strategies as well as be involved in US regulatory activities.

    Leading the design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global cross-functional Project Teams in the UK, US and Japan will be part of the role. Involvement in post-approval work for Centralised products may also be involved.

    As a Senior Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neurosciences therapy area is desirable. You will need prior experience in the resolution of regulatory risks as well as experience in submissions of CTA/MAA. Life cycle management and interfacing with regulatory authorities. All the above will be part of this diverse and exciting role. The Senior Manager will be influential with the financial budget, matrix and team. Strategic experience and forward thinking, cognitive capabilities as well as great organisational and problem-solving skills are required. A BSc/MSc relevant to the role is desired.

    This Senior Manager NBG Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMNBG

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (post marketing) appointment.

    This opportunity will position you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Director you will be a key stakeholder in the company’s regulatory activities and oversee the activities of product development and life cycle management for established products. You will be liasing with authorites globally to market products. As Director of Regulatory Affairs you will manage worldwide interactions and negotiations with stakeholders, agencies and partners to ensure continuity of supply. Strong leadership and strategic implementation is a key focus for this role.

    You will be responsible for managing partnerships from a regulatory standpoint for products/projects and the review and approval of labelling for the company’s products. You must have strong experience with documentation in support of commercial products (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety) and ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects.

    As Director you will oversee direct reports in preparation and management of above responsibilities and assist as needed. This exciting role requires you to have a deep and broad knowledge of regulatory affairs and direct experience with biological and/or pharmaceutical regulatory submissions and product approvals. You must have a proven track record of effective collaboration with regulatory agencies knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format as well as experience in preparation of global regulatory strategies

    A proven record of maintenance of regulatory authorizations and variations in at least two regions and supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODPMJ

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    Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to support the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Manager you will be involved in supporting the European Regulatory activities for an orphan disease pipeline. You will contribute to innovative global regulatory strategies and have opportunities for involvement in US regulatory activities.

    The appointed person will also be the EU Regulatory Lead for an early phase compound, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for both above. Involvement in post-approval work for Centralised products may also be involved.

    As a Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neuroscience therapy areas is desirable. Experience with EU and/or UK regulatory processes and environment, including clinical trials, Regulatory strategy experience and strong strategic thinking skills are needed. As Manager, NBG you will be liaising and negotiating with regulatory authorities, both verbally and in writing. You must be able to operate in a complex environment and adapt well. You will need prior experience in submissions of CTA/MAA. Life cycle management.

    This is a diverse and exciting role that requires an experienced and forward-thinking individual. Strong organisational and problem-solving skills and a BSc/MSc relevant to the role is desired.

    The Manager, NBG Regulatory role is an office-based position with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

  • £65000 - £75000 per annum, + Benefits
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    Global Labelling, Associate Director

    A fantastic opportunity to join an innovative pharma company that is recruiting for an Associate Director for Global Labelling.

    This opportunity will allow for collaborative input making a real difference in the lives of patients and the life sciences. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You will be responsible for the packaging and labelling of pharmaceutical products in accordance with regulations; principally the information printed on the outward packaging and inner leaflet, containing important safety information and any adverse effects.

    Typical day-to-day responsibilities will be authoring PILs and SmPCs. You will also be responsible for updating label information according to health authorities, reviewing documentation and updating the company’s core data sheet.

    They require an experienced professional with Regulatory and Health Authority experience. You will need to understand the artwork, labelling, submissions and variations for different markets. Line management may be required at a later stage. Medical writers are also encouraged to apply. The company is open to an individual with strong knowledge in the area who is looking for the next step in their career.

    This Associate Director of Global Labelling is an office-based position within greater London. This is a fantastic permanent opportunity offering a competitive salary and package.
    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOGLADE

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

  • UK

    £65000 - £75000 per annum, Benefits
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    Senior Safety Evaluation Physician

    An innovative and patient focused pharma company is recruiting for a Senior Safety Evaluation Physician in the Hertfordshire area.

    This fantastic opportunity will allow you to attend appropriate scientific and medical courses all provided to help advance your skills. Offering an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Safety Evaluation Physician you will support the Head of Safety Evaluation, the Qualified Person for Pharmacovigilance (EU QPPV) and the global safety community, in the provision of a comprehensive Pharmacovigilance and Product Safety service internationally and in Europe.

    You will also have opportunity for close interactions with other members of the drug safety community, including safety affiliates and the corporate office.

    They require you to hold a UK GMC-approved or similar medical registration and have demonstrated experience in post-registration clinical medicine.

    This role includes but is not limited to leading the response to safety-related medical queries from regulatory authorities, external bodies and internally for specified product

    As General Safety Officer (GSO) for an assigned group of products, you will support the collection, assessment, evaluation, distribution and reporting of individual and cumulative safety reports.

    The Senior Safety Evaluation Physician will have acquired previous experience in pharmacovigilance during which a consistent record of strong contribution has been demonstrated, in addition to success in tackling new challenges and responsibilities.

    This Senior Safety Evaluation Physician opportunity is an office-based position in the Hertfordshire area. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSSEP

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

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    The Deputy EU QPPV and Deputy Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking The Deputy EU QPPV and Deputy Head of Drug Safety International.

    The Deputy EU QPPV and Deputy Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • M.D Degree
    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (post marketing) appointment.

    This opportunity will position you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Director you will be a key stakeholder in the company’s regulatory activities and oversee the activities of product development and life cycle management for established products. You will be liasing with authorites globally to market products. As Director of Regulatory Affairs you will manage worldwide interactions and negotiations with stakeholders, agencies and partners to ensure continuity of supply. Strong leadership and strategic implementation is a key focus for this role.

    You will be responsible for managing partnerships from a regulatory standpoint for products/projects and the review and approval of labelling for the company’s products. You must have strong experience with documentation in support of commercial products (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety) and ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects.

    As Director you will oversee direct reports in preparation and management of above responsibilities and assist as needed. This exciting role requires you to have a deep and broad knowledge of regulatory affairs and direct experience with biological and/or pharmaceutical regulatory submissions and product approvals. You must have a proven track record of effective collaboration with regulatory agencies knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format as well as experience in preparation of global regulatory strategies

    A proven record of maintenance of regulatory authorizations and variations in at least two regions and supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODPMJ

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    Senior Director of Regulatory Affairs

    An award winning CRO is looking for a Senior Director of Regulatory Affairs to implement the regulatory strategy for specific sponsored projects. This exciting opportunity will allow you to ensure that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the team.

    As RAD you will have strong strategic leadership skills, have a deep experience in regulatory science and overall drug/biologic development processes and strategies. You will be experienced and knowledgeable of therapeutic areas and drug development to influence cross-functional discussions Sponsors and relevant stakeholders.

    You will be accountable for the development and implementation, at a regional or global level, of the regulatory strategy for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the Sponsor; You will be leading and developing a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirement;

    As RAD you will conduct assessments such as regulatory gap analyses, considerations and strategy, risk planning and mitigation; Leading the development and implementation of innovative strategies maximizing the likelihood of regulatory success; You will also be accountable for post-market application maintenance and compliance activities.

    This opportunity will see you monitoring changes in the regulatory environment, both general and specific to the therapeutic area and support and advise teams and department staff accordingly.

    You must have experience providing the regulatory review of study protocols, investigator’s brochures, labelling, and integrated summary documents. In addition, you will collaborate with US regulatory to develop global approval strategies

    At least 8 years of experience or equivalent of regulatory drug development including product approval/launch is required and previous experience in attending and/or helping a team prepare for a Major Health Authority interaction (e.g. EMA, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.) is desirable.

    This is a diversified and challenging position offering a competitive salary and benefits. It is a permanent office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSDM

  • UK

    £50000 - £61000 per annum, Benefits
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    Regulatory Affairs Manager – Medical Device

    An award winning CRO is looking for a Regulatory Affairs Manager – Medical Device. The opportunity will see you become part of a team dedicated to supporting the development of ground-breaking drugs and devices, providing hope for those living with debilitating diseases.

    • You would be responsible for verifying compliance on behalf of clients with regulations, standards and guidance documents.
    • Maintaining and developing processes and procedures in support of the role of European AR
    • Liaising with and responding to requests for information and/ or documentation from Competent Authorities (CA’s).
    • Providing regulatory advice and guidance to Sponsors and the company’s departments to ensure compliance with regulations, standards and guidance documents;
    • Developing scientific and regulatory briefing documents for meetings with the regulatory agencies and bodies;
    • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
    • Minimum five years medical device, in vitro diagnostic and/ or active implantable experience within Regulatory Affairs or in a similar role;
    • Demonstrable experience, including document preparation and/ or writing, clinical trials, post-market activities and regulatory agency interaction;
    • Knowledge of existing medical devices regulations is essential with knowledge of new medical device regulations being highly desirable;
    • Strong computer skills, project management skills, and a high attention to detail;

    This is opportunity to receive a competitive total compensation and benefits package with internal growth opportunities that offers a breath of opportunity to be challenged. It is an office-based role located in greater London. The role requires less than 15% travel.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOMDMM

  • UK

    £50000 - £61000 per annum, Benefits
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    Regulatory Affairs Manager – Medical Device

    An award winning CRO is looking for a Regulatory Affairs Manager – Medical Device. The opportunity will see you become part of a team dedicated to supporting the development of ground-breaking drugs and devices, providing hope for those living with debilitating diseases.

    • You would be responsible for verifying compliance on behalf of clients with regulations, standards and guidance documents.
    • Maintaining and developing processes and procedures in support of the role of European AR
    • Liaising with and responding to requests for information and/ or documentation from Competent Authorities (CA’s).
    • Providing regulatory advice and guidance to Sponsors and the company’s departments to ensure compliance with regulations, standards and guidance documents;
    • Developing scientific and regulatory briefing documents for meetings with the regulatory agencies and bodies;
    • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
    • Minimum five years medical device, in vitro diagnostic and/ or active implantable experience within Regulatory Affairs or in a similar role;
    • Demonstrable experience, including document preparation and/ or writing, clinical trials, post-market activities and regulatory agency interaction;
    • Knowledge of existing medical devices regulations is essential with knowledge of new medical device regulations being highly desirable;
    • Strong computer skills, project management skills, and a high attention to detail;

    This is opportunity to receive a competitive total compensation and benefits package with internal growth opportunities that offers a breath of opportunity to be challenged. It is an office-based role located in greater London. The role requires less than 15% travel.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOMDMM

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    A very rare opportunity for an experienced Program Director to join an exciting niche start-up Biopharma, this position is permanent and office-based in London (some flex)

    This position is with a start-up and niche Biotech focussed in Oncology and will offer very exciting long-term prospects. This is quite a unique opportunity to join the company at early stages so there will be a lot of exposure. They work in exciting and innovative therapy areas.

    The role spans across pre-clinical through to clinical trials specifically in Oncology. They need a very experienced individual who is also happy to do hands on work. This is a very cross-functional role with oversight of an asset/compound.

    This is a permanent and full-time position. It is office-based in London offering an excellent salary + bonus + benefits (over £100K package).

    Skills Alliance are the exclusive partner for this role, please contact Mark Anderson for more details +44 207 220 6209 or click APPLY NOW!

  • £65000 - £75000 per annum, bonus + benefits
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    A very rare opportunity for an experienced (Senior) Study Manager or (Senior) Trial Manager to join an exciting niche start-up Biopharma, this position is permanent and office-based in London.

    This position is with a start-up and niche Biotech focussed in Oncology and will offer very exciting long-term prospects. This is quite a unique opportunity to join the company at early stages so there will be a lot of exposure. They work in exciting and innovative therapy areas.

    The Senior Clinical Trial Manager role is a great opportunity for Study Manager to work in a wide ranging study management role, they would prefer someone who has worked closely with data management. They require a strong project management management experience from Pharma or Biotech and Oncology. This would be working on early phase trials.

    This is a permanent and full-time position. It is office-based in London offering around GBP 65-75K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this role, please contact Mark Anderson for more details +44 207 220 6209 or click APPLY NOW!

  • £65000 - £75000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Senior Clinical Trial Manager or Senior Clinical Study Manager role based in Hertfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Senior Study Manager, this would be working on interesting early phase studies. They require a strong clinical trial management background, ideally experience in early phase, complex TAs and ideally program level experience. It would be overseeing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home. They offer an excellent salary and package around GBP 65-70K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this CPM / Senior CPM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • £60000 - £75000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager or Senior Clinical Study Manager role based in London and working in cell therapy.

    This exciting and innovative Biopharma are at early stages with trials working in a range of disease areas in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager to join the team, this would be working on studies at the cutting edge of science.

    This is a full-time and permanent position. It is office-based in London with flexibility to work from home for the right candidate. They offer an excellent salary and package around GBP 60-75K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Senior Clinical Study Manager / Senior Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

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    Skills Alliance are partnered with an International CRO that is currently expanding their CRA group. For this purpose, our client will be looking for multiple Freelance Clinical Research Associates to join their team home-based in France.

    If you are a Clinical Research Associate with at least 2-4 years of monitoring experience and are looking for a new opportunity, then feel free to get in touch.

    REQUIREMENTS

    – A Bachelor’s degree in natural/life science, pre-medicine, nursing, bio-engineering, or a related field
    – Minimum 2 years clinical research experience
    – Strong written and verbal communication skills and the ability to interpret basic clinical data
    – Basic IT Skills (i.e., word processing software and relevant clinical applications)
    – Ability to work independently in a global team environment and to exchange straightforward information
    – Proficient level of English and French
    – Relevant certification by an industry-recognized professional society

    For more information please contact Egi Bendo at +41 43 508 21 04.

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    Skills Alliance are partnered with an International CRO that is currently expanding their CRA group. For this purpose, our client will be looking for multiple Freelance Clinical Research Associates to join their team home-based in Germany.

    If you are a Clinical Research Associate with at least 2-4 years of monitoring experience and are looking for a new opportunity, then feel free to get in touch.

    REQUIREMENTS

    – A Bachelor’s degree in natural/life science, pre-medicine, nursing, bio-engineering, or a related field
    – Minimum 2 years clinical research experience
    – Strong written and verbal communication skills and the ability to interpret basic clinical data
    – Basic IT Skills (i.e., word processing software and relevant clinical applications)
    – Ability to work independently in a global team environment and to exchange straightforward information
    – Proficient level of English and German
    – Relevant certification by an industry-recognized professional society

    For more information please contact Egi Bendo at +41 43 508 21 04.

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    Skills Alliance are partnered with an International CRO that is currently expanding their CRA group. For this purpose, our client will be looking for multiple Freelance Clinical Research Associates to join their team home-based in Austria.

    If you are a Clinical Research Associate with at least 2-4 years of monitoring experience and are looking for a new opportunity, then feel free to get in touch.

    REQUIREMENTS

    – A Bachelor’s degree in natural/life science, pre-medicine, nursing, bio-engineering, or a related field
    – Minimum 2 years clinical research experience
    – Strong written and verbal communication skills and the ability to interpret basic clinical data
    – Basic IT Skills (i.e., word processing software and relevant clinical applications)
    – Ability to work independently in a global team environment and to exchange straightforward information
    – Proficient level of English and German
    – Relevant certification by an industry-recognized professional society

    For more information please contact Egi Bendo at +41 43 508 21 04.

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    Skills Alliance are partnered with an International CRO that is currently expanding their CRA group. For this purpose, our client will be looking for multiple Freelance Clinical Research Associates to join their team home-based in Switzerland.

    If you are a Clinical Research Associate with at least 2-4 years of monitoring experience and are looking for a new opportunity, then feel free to get in touch.

    REQUIREMENTS

    – A Bachelor’s degree in natural/life science, pre-medicine, nursing, bio-engineering, or a related field
    – Minimum 2 years clinical research experience
    – Strong written and verbal communication skills and the ability to interpret basic clinical data
    – Basic IT Skills (i.e., word processing software and relevant clinical applications)
    – Ability to work independently in a global team environment and to exchange straightforward information
    – Proficient level of English and German/French/Italian
    – Relevant certification by an industry-recognized professional society

    For more information please contact Egi Bendo at +41 43 508 21 04.

  • £60000 - £70000 per annum
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    ***ENTRY/JUNIOR LEVEL MEDICAL ADVISOR ROLE***

    A world-class mid-size pharma are recruiting for an EMEA Medical Advisor position based in the Hertfordshire area.

    You will have the opportunity to join a patient-driven global pharmaceutical company located north of London, who have an extensive Neurology portfolio and are expanding worldwide, offering you opportunities for progression and growth.

    This is a cross-functional and strategic Medical Affairs role at EMEA level. You would liaise with the EMEA Team to support EMEA Medical Affairs plans, provide scientific, medical and technical support, marketing, training and sales activities for the Neurology portfolio in line with the EMEA strategy.

    The EMEA Medical Advisor position is an office-based role offering flexibility to work from home and international travel involved. The salary offered is between £ 60000-70000 (depending on experience) + benefits + bonus + car allowance.

    GMC/GPhC registration is required, as well as NEUROLOGY experience.

    Skills Alliance are the preferred company for this role. For more information about this opportunity or any similar opportunities, please contact Silvia Gullone on 0044 (0)207 220 6219.

  • £75000 - £85000 per annum, Bonus and Benefits
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    A leading Biotech organization based in Central London are recruiting for a Principal Investigator to supervise early phase trials.

    You will have the opportunity to join an expanding company which is a pioneering clinical trial platform for the development of Respiratory Disease products. Their portfolio also includes Infectious Disease and Immunology.

    The role will be an exciting opportunity for physicians working in clinical development to gain exposure in phase I/II trials and work in close contact with the patients. In cooperation with other clinical units, the Principal Investigator will lead the staff during the development of clinical trials, along with supervising patient screenings and directing medical duties.

    The Principal Investigator position is an office-based role located in the heart of London. It is a permanent position offering around 75-85K depending on the experience + bonus and benefits. GMC registration is required.

    Skills Alliance are the preferred company for this role. For more information about this opportunity or any similar opportunities, please contact Silvia Gullone on 0044 (0)207 220 6219.

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    A leading pharmaceutical company are recruiting for a Key Account Manager, covering London and Essex within anti-infectives (anti-fungal).

    You would be responsible to sell niche pharmaceutical products to healthcare specialists, whilst always representing the company to high ethical principles. You will work with and report into your Regional Account Manager. You will create solid customer relationships assembled on your perception of their requirements and your capacity to demonstrate your integrity by filling those requirements. You will exhibit a high degree of knowledge within your specialist therapeutic area and utilize a variety of promotional strategies to successfully execute them. Contributing to the sales team and wider account teams you work within, whilst building and securing business strategies and conveying them successfully.

    The Key Account Manager role is entirely field based. It’s a permanent role offering an excellent package with a competitive salary.

    Skills Alliance are the preferred supplier for this role. Please contact Warda Issa for more details on +44 203 823 4158.

  • UK

    £50000 - £60000 per annum, benefits
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    A cutting-edge Patient Recruitment company is seeking an experience Patient Recruitment Manager to join their growing team.

    This is a unique opportunity to move into a highly visible role within the UK whilst working closely with senior management. You will be responsible for overseeing patient enrolment for various research sites whilst leading a team of ambitious employees.

    Responsibilities:

    • Oversee patient enrolment and recruitment strategies
    • Work closely with research sites in order to hit enrolment targets
    • Oversee patient recruitment specialists and coordinators

    Experienced Required:

    • 3 years patient recruitment experience at manager level
    • Experience working with seniors a bonus
    • A track record of hitting and exceeding enrolment targets

    For more info please contact Troy Neenan on 02072206237 or click apply.

  • UK

    £40000 - £48000 per annum, bonus
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    I am partnered with mid-sized Pharma company specialising in Advanced Therapies who are seeking a Junior Study Manager to join their growing team. This is a great opportunity for an experienced CRA to join move away from monitoring and into project management.

    You will be responsible for coordinating phase III studies whilst also managing a small-scale study. The Junior Study Manager role will also encompass vendor management of the CRO.

    Experience:

    • 3 years independent monitoring experience within CRO or Pharma.
    • Experience working in complex therapy areas.
    • Experience coordinating studies advantageous

    For more info please contact Troy Neenan on 02072206237.