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    Senior Regulatory Affairs Associate

    As Senior Regulatory Affairs Associate you will have the opportunity to work alongside committed and dynamic investigators and sponsors, progressing important and exciting oncology studies.

    You will have the chance to work with a highly experienced team, in an environment that is flexible exposing you to a rapidly changing clinical trials environment. Meaning, you will be able to progress projects from inception to completion in a fast-paced environment.

    As Senior Regulatory Affairs Associate you will have the opportunity to work on fascinating scientific developments and discoveries whilst being challenging and constantly rewarded.

    Main responsibilities include –

    • Management, preparation, assembly and submission of European:
    • Clinical Trial Authorisation Applications (CTAA) and amendments.
    • Country-level Informed Consent and other patient facing documentation.
    • Tracks, reports and files CTAA and amendment submission/approval progress in electronic trial master files (eTMF), clinical trials management system (CTMS) or other applicable systems.
    • Provides consultancy to the client on European CT regulatory specific issues.
    • Participates in the quality control (QC) steps involved for all of the above.
    • Serves as key regulatory liaison for multi-continental projects on behalf of Oncology (Europe). Liaison with other departments within including Data Management, Medical Writing, Pharmacovigilance, Quality Assurance and Drug Distribution.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by regulatory agencies and ethics committees.
    • Provides regulatory training to other members of the team, as required.

    This is a full-time opportunity offering a competitive salary and office / home-based flexibility.

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

    Reference #IOSRAT

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    Regulatory Affairs Associate

    As Regulatory Affairs Associate you will have the opportunity to work alongside committed and dynamic investigators and sponsors, progressing important and exciting oncology studies.

    You will have the chance to work with a highly experienced team, in an environment that is flexible exposing you to a rapidly changing clinical trials environment. Meaning, you will be able to progress projects from inception to completion in a fast-paced environment.

    As Regulatory Affairs Associate you will have the opportunity to work on fascinating scientific developments and discoveries whilst being challenging and constantly rewarded.

    Main responsibilities include –

    • Management, preparation, assembly and submissions of European:
    • Clinical Trial Authorisation Applications (CTAA) and amendments
    • Country-level Informed Consent and other patient facing documentation
    • Tracks, reports and files CTAA and amendment submissions / approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
    • Provides consultancy to the client on European CT regulatory Specific issues.
    • Participates in the quality control (QC) steps involved for all the above.
    • Serves as key regulatory liaison for multi-continental project on (Oncology (Europe). Liaison with other departments, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by IECs and CA’s.
    • Provides regulatory training to other members of the team as required.


    This is a full-time opportunity offering a competitive salary and office based

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

    Reference #IORAAT

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    Share

    Regulatory Affairs Officer

    As Regulatory Affairs Officer you will have the opportunity to work alongside committed and dynamic investigators and sponsors, progressing important and exciting oncology studies.


    You will have the chance to work with a highly experienced team, in an environment that is flexible exposing you to a rapidly changing clinical trials environment. Meaning, you will be able to progress projects from inception to completion in a fast-paced environment.

    As Regulatory Affairs Officer you will have the opportunity to work on fascinating scientific developments and discoveries whilst being challenging and constantly rewarded.

    Main responsibilities include –

    • Management, preparation, assembly, submission and full oversight for:
    • Clinical Trial Authorisation Applications (CTAA) and amendments.
    • All other regulatory and patient facing documents required to support ongoing approval of clinical trials, including all required translations, in accordance with the required current legislation and guidelines.
    • Tracks, reports, files and maintains oversight of CTAA and amendment submission / approval progress in electronic trial master files (eTMF), clinical trials management system (CTMS) or other applicable systems.
    • Ensures all CTAAs and amendments are submitted in accordance with clients’ timelines.
    • Participates in the quality control (QC) steps and ensures each submission has been checked by an appropriately qualified member of the regulatory group prior to submission.
    • Ensures all queries raised by Ethics Committees (ECs) and regulatory authorities (RAs) are addressed within required timeframes, including management of applicable negotiations.
    • Maintains metrics monthly of all regulatory submissions made by.
    • Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by RAs and ECs.
    • Provides training on the requirements for RA and EC submissions, and any other regulatory related issues, as required.

    This is a full-time opportunity offering a competitive salary and office / home-based flexibility.

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

    Reference #IOSRAT

  • Apply

    Job
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    Share

    Regulatory Affairs Officer

    As Regulatory Affairs Officer you will have the opportunity to work alongside committed and dynamic investigators and sponsors, progressing important and exciting oncology studies.


    You will have the chance to work with a highly experienced team, in an environment that is flexible exposing you to a rapidly changing clinical trials environment. Meaning, you will be able to progress projects from inception to completion in a fast-paced environment.

    As Regulatory Affairs Officer you will have the opportunity to work on fascinating scientific developments and discoveries whilst being challenging and constantly rewarded.

    Main responsibilities include –

    • Management, preparation, assembly, submission and full oversight for:
    • Clinical Trial Authorisation Applications (CTAA) and amendments.
    • All other regulatory and patient facing documents required to support ongoing approval of clinical trials, including all required translations, in accordance with the required current legislation and guidelines.
    • Tracks, reports, files and maintains oversight of CTAA and amendment submission / approval progress in electronic trial master files (eTMF), clinical trials management system (CTMS) or other applicable systems.
    • Ensures all CTAAs and amendments are submitted in accordance with clients’ timelines.
    • Participates in the quality control (QC) steps and ensures each submission has been checked by an appropriately qualified member of the regulatory group prior to submission.
    • Ensures all queries raised by Ethics Committees (ECs) and regulatory authorities (RAs) are addressed within required timeframes, including management of applicable negotiations.
    • Maintains metrics monthly of all regulatory submissions made by.
    • Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by RAs and ECs.
    • Provides training on the requirements for RA and EC submissions, and any other regulatory related issues, as required.

    This is a full-time opportunity offering a competitive salary and office / home-based flexibility.

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

    Reference #IOSRAT

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Senior Regulatory Affairs Associate

    As Senior Regulatory Affairs Associate you will have the opportunity to work alongside committed and dynamic investigators and sponsors, progressing important and exciting oncology studies.

    You will have the chance to work with a highly experienced team, in an environment that is flexible exposing you to a rapidly changing clinical trials environment. Meaning, you will be able to progress projects from inception to completion in a fast-paced environment.

    As Senior Regulatory Affairs Associate you will have the opportunity to work on fascinating scientific developments and discoveries whilst being challenging and constantly rewarded.

    Main responsibilities include –

    • Management, preparation, assembly and submission of European:
    • Clinical Trial Authorisation Applications (CTAA) and amendments.
    • Country-level Informed Consent and other patient facing documentation.
    • Tracks, reports and files CTAA and amendment submission/approval progress in electronic trial master files (eTMF), clinical trials management system (CTMS) or other applicable systems.
    • Provides consultancy to the client on European CT regulatory specific issues.
    • Participates in the quality control (QC) steps involved for all of the above.
    • Serves as key regulatory liaison for multi-continental projects on behalf of Oncology (Europe). Liaison with other departments within including Data Management, Medical Writing, Pharmacovigilance, Quality Assurance and Drug Distribution.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by regulatory agencies and ethics committees.
    • Provides regulatory training to other members of the team, as required.

    This is a full-time opportunity offering a competitive salary and office / home-based flexibility.

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

    Reference #IOSRAT

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Regulatory Affairs Associate

    As Regulatory Affairs Associate you will have the opportunity to work alongside committed and dynamic investigators and sponsors, progressing important and exciting oncology studies.

    You will have the chance to work with a highly experienced team, in an environment that is flexible exposing you to a rapidly changing clinical trials environment. Meaning, you will be able to progress projects from inception to completion in a fast-paced environment.

    As Regulatory Affairs Associate you will have the opportunity to work on fascinating scientific developments and discoveries whilst being challenging and constantly rewarded.

    Main responsibilities include –

    • Management, preparation, assembly and submissions of European:
    • Clinical Trial Authorisation Applications (CTAA) and amendments
    • Country-level Informed Consent and other patient facing documentation
    • Tracks, reports and files CTAA and amendment submissions / approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
    • Provides consultancy to the client on European CT regulatory Specific issues.
    • Participates in the quality control (QC) steps involved for all the above.
    • Serves as key regulatory liaison for multi-continental project on (Oncology (Europe). Liaison with other departments, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by IECs and CA’s.
    • Provides regulatory training to other members of the team as required.


    This is a full-time opportunity offering a competitive salary and office based

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

    Reference #IORAAT

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    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    Drug Safety Manager

    An expanding CRO is recruiting for a Drug Safety Manager to join their growing team based in Finland.

    This opportunity will see you take a strong lead in their growing safety services, with an international (focus on Europe, collaboration in US and Japan).

    As Drug Safety Manager you will be offered an interesting position that will give you the opportunity to work with an internationally-growing CRO. You will be part of business-minded surroundings working with experts in the field.

    You are warmly welcome to the team if you are/have:

    • Broad experience in pharmacovigilance/drug safety, with knowledge of medical terminology and GVP
    • Sales/business-oriented
    • Experience in leadership
    • Able to understand business
    • Project management skills
    • Effective communication skills (written and spoken)
    • A good command of Finnish and English (written and spoken)
    • This is a full-time opportunity offering a competitive salary.

    This is an office based role in Finland that offers home based flexibility.

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

    Reference #IODSMM

  • £30000 - £40000 per annum, Benefits
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    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

    £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

  • £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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    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

    $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

    $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

    $325000 - $400000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    Skills Alliance is partnered with an exceptional biotech in the north east that is looking to bring on board a VP of Clinical Development. My client is an oncology focused biotech that is rapidly growing in the Tri-State area and they are looking to bring onboard another pillar of the company.

    The VP must be an M.D. that excels in small teams. This individual will be reporting into the CEO and will be pivotal for the development of their assets. The ideal candidate would have spent most of their career in the oncology space and been exposed across all phases of studies. The assets that the VP would cover will be primarily late phase work, which enables one to have the possiblity to bring a product to market soon. The Vice President will also have the ability to shape the culture and the team underneath them as they are working hand in hand with the CEO in this role. Great opportunity for mentoring junior staff and having leadership responsibilities.

    Along with the very interesting nature of this role, the compensation package can be very lucrative as well.

    If you were interested in learning more about the opportunity, please submit a copy of CV for consideration.

  • 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 apply directly via the “apply” button above.

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    Skills Alliance are partnered with a CRO that is currently expanding their clinical operations team in Belgium. For this purpose, our client will be looking for a Freelance Clinical Research Associate.

    JOB TITLE

    Freelance Clinical Research Associate

    1.0 FTE

    LOCATION

    Belgium

    RATE

    Competitive rate + Expenses

    ROLE

    The Freelance CRA will be involved in site management and monitoring of clinical trials across a wide spectrum of therapeutic areas, ensuring that all activities are conducted in accordance with national/international regulations and ICH GCP. The candidate will carry out on-site and remote monitoring visits including selection, initiation, monitoring and close-out.

    REQUIREMENTS

    – University degree in Life Sciences, Bioengineering, Biomedicine, or equivalent by experience
    – At least 4 years of clinical research experience
    – Experience in Phases I-IV
    – Fluent in French, Dutch, and English

    If you are interested in this opportunity please feel free to reach out to Egi Bendo.
    Phone: +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 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

    Relevant certification by an industry-recognized professional society

    For more information: please contact Heena Verma at +41 (0) 447982410

  • Competitive salary + benefits
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    A growing CRO is recruiting for a Clinical Research Nurse position to be based in London.

    This is an opportunity to join a growing company that is expanding a lot at the moment and will continue to do so over the next few years. As they expand there will be excellent opportunities for progression and development.

    You would be responsible for coordinating effectively their studies. They require a Senior Clinical Research Nurse or a Clinical Research Nurse who has strong experience. They are recruiting for their

    This role is based in London. It is a permanent role offering a competitive salary + bonus + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Maria Matei for more details on +44 203 948 5299.

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    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

    Relevant certification by an industry-recognized professional society

    For more information please contact HeenaVerma at +41 (0) 447982410

  • UK

    £30000 - £35000 per annum, benefits
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    I am working with a growing Biotech focused in Gene Therapy who are looking for an experienced Clinical Trial Assistant to join their team.

    This is a rare opportunity to get full exposure to complex studies and take on a wide range of responsibilities, you will also work closely with the Director of Clin Ops. This is a fully office-based position in Central London offering a flexible salary between £30,000 – £35,000 plus benefits.

    Experience:

    • 2 years plus experience within CRO or Pharma
    • TMF/E-TMF experience required
    • Experience working in a fast paced and dynamic environment an advantage

    For more info please contact Troy Neenan on 02072206237.

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    Senior Scientist – Newly Created Position – Growing company

    A client of mine who are dedicated to the formulation and development of inhalation devices have created a brand new role within their research and development department and are looking for an experienced scientist to join as a Senior Scientist.

    Due to growth within the business, this position will give any experienced scientist the opportunity to further develop their skills within the pharmaceutical industry, thereby further progressing your career. Although this role comes with no line management, given the amount of this company is going through at the moment, this is a possibility in the future and you will be expected to initially work closely with junior members of the team to mentor and guide them in their professional development.

    For this position, you should have experience working in a GMP, CMC environment and have worked in the field of respiratory with a particular focus on working with inhalers. HPLC experience, as well as experience testing next generation impactors will also be required for this position.

    This position is based close to Bath.

    For morning information on this position or any similar opportunities, please contact Chanel Hicken on 0207 220 6206. Alternatively, email me your CV and we can arrange a time to speak.

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    Skills Alliance is exclusively partnered with a mid-sized Biopharmaceutical company seeking to hire a new Executive Director, Medical Affairs International to lead the overall Medical Affairs strategy and activities of the successful haematology/oncology franchise.

    The organisation has an established and expanding footprint in the International markets with nine affiliate offices and a total team of ~60 in medical affairs. With accountability for developing, leading and executing the Medical Affairs strategy, this is a highly visible and high profile role, reporting to the VP Medical Affairs International. This role is located in the Headquarters and has directs reports of both Medical Directors and Associate Medical Directors aligned to the products in the haematology/oncology portfolio.

    This is a dynamic, science-focused organisation with a highly collaborative environment. The clinical development pipeline includes both new assets and line extensions for existing products across an array of indications with many potential launches expected over coming years.

    There is a strong preference for a Medical Doctor with a clinical/pharmaceutical background in haemato-oncology / rare or orphan disease / transplantation combined with extensive experience in team management and leadership. Above-country experience at European / Regional / Global level is strongly preferred due to the broad geographical remit of the position.

    This role requires office presence for the majority of the working week, aside of international travel (approx. 30%). Relocation and VISA assistance may be available, dependent on circumstances.

    Commensurate with the high accountability of this position, the salary and package are both extremely competitive and include a significant cash bonus (30% of annual salary) as well as joining equity in the form of RSUs and Options. More details can be provided upon application.

    Skills Alliance is exclusively partnered with this organisation: All queries should be directed to Karina Sharipova, Head of Executive Research, who will be able to provide further information. Please call Karina on +44 (0) 207 220 6205 or click APPLY to submit a copy of your CV.

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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 Central 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!

  • £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 60-70K 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.

  • £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.

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

    This position is with a start-up and niche Biotech who work in gene therapy 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 Clinical Program Manager role is a great opportunity for an experienced individual to work in a wide ranging role, it would be working on a cross-functional basis. They require a strong project management management experience from Pharma, Biotech or CRO. The trials span phases I-III.

    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!

  • £45000 - £55000 per annum, bonus + benefits
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    A very rare opportunity for an experienced Associate Study Manager or Clinical Study Manager to join an exciting niche start-up Biotech, this position is permanent and office-based in Central London.

    This position is with a start-up and niche Biotech who work in gene therapy 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 Clinical Study Manager role is a great opportunity for an experienced individual to work on exciting gene therapy projects on an international basis, they would prefer a CRA background and some trials management experience from Pharma, Biotech or CRO. The trials span phases I-III.

    This is a permanent and full-time position. It is office-based in London offering around GBP 45-55K 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!

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    I am partnered with a key player in the field of neurology seeking a highly driven key account manager to join a brilliant team at an exciting time with both strong established products & innovative pipeline new indications. Breakthroughs in the area mean forecasted sales for the current service portfolio are predicted best year to date.

    You will be responsible for selling highly innovaive and niche products, building and securing business strategies and conveying them successfully. This will involve strategic model & key account planning to target & segment customers as well as preparing & supporting launches of new innovative products & indications into the market. Allowing a cross functional strategic position in working closely with KOLs at high level and challenging approaches & perspectives.

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

    Skills alliance is partnered exclusivley for this role. Please contact Stephanie George | +44 0207 220 6224

  • UK

    £30000 - £35000 per annum, benefits
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    I am working with a growing Biotech focused in Gene Therapy who are looking for an experienced Clinical Trial Assistant to join their team.

    This is a rare opportunity to get full exposure to complex studies and take on a wide range of responsibilities, you will also work closely with the Director of Clin Ops. This is a fully office-based position in Central London offering a flexible salary between £30,000 – £35,000 plus benefits.

    Experience:

    • 2 years plus experience within CRO or Pharma
    • TMF/E-TMF experience required
    • Experience working in a fast paced and dynamic environment an advantage

    For more info please contact Troy Neenan on 02072206237.

  • UK

    £40000 - £55000 per annum, benefits
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    I am partnered with mid-sized Pharma company specialising in Oncology 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.

  • UK

    £40000 - £50000 per annum, benefits
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    I am partnered with a reputable CRO who are looking for an experienced CRA to join their team. This is a rare opportunity to move into a regionalised monitoring role whilst working in more of a quality driven environment. This is an ideal position for someone who is tired of national monitoring and is keen to work in a less metrics driven environment.
    Responsibilities:

    • Responsible for routine site visits
    • Start-up activities
    • Mentoring and training of CRAs

    Experience:

    • 18 months + independent monitoring experience
    • Experience working in complex therapy areas
    • Scientific degree or equivalent

    For more information please call Troy Neenan on 02072206237 or click apply.

  • UK

    £30000 - £40000 per annum
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    I am working with a growing Biotech focused in Gene Therapy who are looking for an experienced Clinical Trial Assistant to join their team. This is a rare opportunity to get full exposure to complex studies and take on a wide range of responsibilities, you will also work closely with the Director of Clin Ops.

    This is a fully office based position in Hertfordshire offering a flexible salary between £30,000 – £40,000 plus benefits.

    Experience:

    • 2 years plus experience within CRO or Pharma
    • TMF/E-TMF experience required
    • Experience working in a fast paced and dynamic environment an advantage

    For more info please contact Troy Neenan on 02072206237.