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  • Competitive Salary and benefits package
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    Skills Alliance has been exclusively retained by a clinical-stage biotechnology company to hire a CMC Technical Writer to join their growing CMC team.

    The company has an innovative and active research pipeline focused on developing biologics for the treatment of rare autoimmune conditions and oncologic diseases. The biotech’s pipeline is advancing with global phase III trials underway.

    The CMC Technical Writer will create and evaluate quality submission packages for the company’s therapeutic drug candidates in phases I-III towards their market approval. As the function continues to grow, there is an opportunity to become involved in CMC development strategies and take on further CMC responsibilities of interest. The role reports to the Head of CMC and will be based in Belgium.

    Responsibilities:

    • Author technical materials for drug development activities
    • Create and prepare materials (IMPD, IND, Investigator Brochures, etc.) for therapeutic compounds being developed, in close collaboration with internal and external stakeholders
    • Create and prepare quality documentation packages (ex. Common Technical Documents, Biologics License Applications and Marketing Authorisation Applications) for Modules 2 and 3
    • Ensure the completion and compliance of submission packages in line with regulatory and country-specific requirements
    • Keep track of the execution of regulatory requirements
    • Provide strategic insights into CMC development activities
    • Involvement in CMC development of pre-clinical and clinical programs and collaboration with other function members

    Qualifications:

    • Master’s Degree or PhD in relevant field of study
    • Strong competence in CMC development and creation of regulatory dossiers (e.g. INDs, MAAs)
    • Large molecules experience preferred
    • Knowledge of ICH guidelines, pharmacopoeial requirements, and local and international regulatory agency guidelines (FDA, EMA)
    • Ability to collaborate and build strong relationships with external and internal stakeholders
    • Proficiency with MS Word and other document management programs

    Skills Alliance is exclusively partnered with this innovative biotech. Please click APPLY or contact Karina Sharipova at 0044 207 220 6205 to receive further information, including a full job description.

  • USA

    $140000 - $160000 per annum, bonus, relocation, equity etc
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    My client is seeking a highly motivated computational biologist to join our their organization, a next generation CAR-T cell company dedicated to applying breakthrough technologies to the successful development of curative therapies for solid tumors.

    The successful candidate should have a strong computational background with proven track record of having applied computational solutions to solve complex biological problems. The candidate should have the ability to work independently and come up with quick, robust and creative computational solutions to various research goals.

    Qualifications:

    • Flow and imaging techniques (flow cytometry)
    • Immunology or cancer experience is a plus
    • NGS experience
    • PhD in a related field
    • Experience in analysis of large-scale genomic data such as RNA-seq, ATAC-seq, ChIP-Seq, and high-dimensional flow cytometry datasets, as well as biological pathway related analysis
    • Experience in developing end-to-end analytical pipelines that are robust and modular

    My client is looking to hire quickly for this opportunity so please do no hesitate to apply!

  • Competitive Salary and benefits package
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    Skills Alliance has been exclusively retained by a clinical-stage biotechnology company to hire a GCP Quality Manager. With multiple global trials underway, this position will provide GCP guidance to clinical study teams.

    The company has an innovative and active research pipeline focused on developing biologics for the treatment of rare autoimmune conditions and oncologic diseases. Their pipeline is advancing with multiple assets and a high-profile external collaboration in phases I-III.

    This position will play a pivotal role in leading the clinical study team across all quality matters, provide oversight of audit conduct and ensure GCP inspection readiness. This is an opportunity to provide strategic input into the monitoring and reporting of quality metrics. The role is office-based in Belgium and reports to the Head of Quality.

    Responsibilities:

    • Educate the clinical study team on clinical related quality matters
    • Lead the implementation of quality requirements across phase I-III clinical studies
    • Create and execute study quality plans, audit programs, study risk management plans and risk responses
    • Lead study-specific audit site selection processes and supervise the audit conduct, reporting and review in line with company processes
    • Contribute to lead inspection readiness activities and GCP audits
    • Lead investigations into study quality events and define corrective and preventative measures to such events
    • Monitor quality risks and outline risk limiting measures for studies, sites and vendors
    • Produce GCP quality metrics from real-time quality reporting and monitoring, working closely with the clinical study team
    • Ability to collaborate and build strong relationships with external and internal stakeholders

    Qualifications:

    • Several years’ experience in clinical quality management
    • Extensive knowledge of ICH, EU and FDA clinical regulations and guidelines
    • Outstanding communication skills and proven track record of leadership and accountability
    • Fluency in English

    Skills Alliance is exclusively partnered with this innovative biotech. Please click APPLY or contact Karina Sharipova at 0044 207 220 6205 to receive further information, including a full job description.

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    Skills Alliance has partnered exclusively with a world-leading pharma company to hire a Director, Global Safety Physician for their oncology business. The organization has a large portfolio of innovative medicines with numerous market-leading positions. Their oncology business is a priority and growing fast due to significant R&D investment and a proactive M&A strategy. This position is instrumental to the safety evaluation and risk management of their oncology assets, including both solid and haematological cancers. The role will provide strategic and operational support to the Safety Leadership Team and wider business.

    Responsibilities will include:

    • Providing clearly defined safety strategies and contributing to safety methodologies
    • Conducting signal detection for designated products using appropriate methods and communicating the results to clinical teams and stakeholders
    • Ensuring promotional materials and communications are in line with internal codes of practice
      • Providing strategic medical input into regulatory requests, reports and submissions and acting as the medical sign-off
      • Evaluating adverse events and safety information in line with global compliance and regulatory requirements

    The successful candidate will have:

    • M.D. or equivalent
    • Previous experience in clinical setting
    • Expertise in the field of oncology
    • Knowledge of clinical development processes and understanding of the drug approval processes of major countries
    • Proficient knowledge of pharmacovigilance regulations and methodologies related to oncology products

    Please click APPLY or contact Karina Sharipova at 0044 207 220 6205 to receive further information, including a full job description.

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    Skills Alliance is exclusively collaborating with Takeda Pharmaceuticals to recruit multiple Validation Engineers specialized in CSV for Takeda’s production site in Lessines, Belgiun.

    The Validation Engineer performs qualification / validation activities linked to his/her part of the business (Computerized Systems Validation). He/She prepares and implements the validation documentation required to assure the proper development of a project. He/She manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    Main responsibilities are:

    1) Prepare and implement the validation documentation required to assure the proper development of a project.

    2) Act as a validation representative for projects, with support of his/her Validation Supervisor: Define and implement all validation activities related to the project. Develop the Validation Plans: define validation methodology and approach in line with the Validation Supervisor. Provide validation expertise for the development of the project. Conduct the risk assessment related to the project. Review the URS, FS, DS and DR. Prepare the DQ. Review the commissioning protocols and reports to ensure leveraging into qualification. Prepare the IQ, OQ & PQ protocols. Assure requirements traceability throughout the whole project validation file (from URS to PQ). Organize and coordinate IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required) Analyze, interpret, document and report the testing results. Ensure the follow-up and tracking of the validation activities. Update the validation documentation system. Assure feedback of status and issues to the Validation Supervisor.

    3) Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.

    4) Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    5) Support junior validation engineers as well as provide day to day guidance for the execution of Validation activities.

    6) Defend validation topics related to his/her projects during Regulatory Inspection and prepare validation parts of the submission file.

    7) Assuring the ability to meet the Department goals in respect to Quality, Finances, Fulfillment and EHS.

    Required profile:

    • Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
    • Minimum 2 years of experience in Validation/Quality systems Skills: Project management experience Excellent communication skills, fluent in French and good knowledge of English (written and spoken)
    • Familiar with Quality Management and GxP Regulations
    • Knowledge of Validation Methodologies Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
    • Knowledge of the manufacturing processes
    • Requires excellent analytical skills with systematic approaches to problem solving.
    • Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
    • Sound industry knowledge, project proficiency, and autonomy expected.

    For this position, our client is offering relocation assistance for candidates coming from outside of Belgium and sponsorship for non-EU candidates speaking fluent French and meeting all criterias mentioned above.

    If you would like to receive more information about this position, please contact Khephren Mongongu +41 43 508 29 16 or click apply. We’re looking forward to receiving your application.

  • UK

    Competitive Salary and benefits package
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    Skills Alliance has partnered exclusively with a world-leading pharma company to hire a Director, Global Safety Physician for their oncology business. The organization has a large portfolio of innovative medicines with numerous market-leading positions. Their oncology business is a priority and growing fast due to significant R&D investment and a proactive M&A strategy. This position is instrumental to the safety evaluation and risk management of their oncology assets, including both solid and haematological cancers. The role will provide strategic and operational support to the Safety Leadership Team and wider business.

    Responsibilities will include:

    • Providing clearly defined safety strategies and contributing to safety methodologies
    • Conducting signal detection for designated products using appropriate methods and communicating the results to clinical teams and stakeholders
    • Ensuring promotional materials and communications are in line with internal codes of practice
    • Providing strategic medical input into regulatory requests, reports and submissions and acting as the medical sign-off
    • Evaluating adverse events and safety information in line with global compliance and regulatory requirements

    The successful candidate will have:

    • M.D. or equivalent
    • Previous experience in clinical setting
    • Expertise in the field of oncology
    • Knowledge of clinical development processes and understanding of the drug approval processes of major countries
    • Proficient knowledge of pharmacovigilance regulations and methodologies related to oncology products

    Please click APPLY or contact Karina Sharipova at 0044 207 220 6205 to receive further information, including a full job description.

  • UK

    Competitive Salary and benefits package
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    Skills Alliance has been exclusively retained by a specialty pharmaceutical company to hire a Microbiology Manager, to provide leadership and guidance to the function as they prepare for an FDA audit later this year.

    Our client is committed to delivering specialty CNS products and enjoys both global and national partnerships with healthcare providers and facilities. The Microbiology Manager will be part of the FDA readiness project team and will act as the head representative for inspections. The role is highly visible and will be the subject matter expert, reporting to the UK Quality Director.

    The Microbiology Manager will facilitate the compliance of appropriate GMP/GLP requirements, provide Microbiology support to the Quality team in the event of an environmental excursion and mitigate current and future compliance risks. Experience with MHRA inspections is a must, with FDA inspection experience desirable.

    Job Responsibilities:

    • Lead and direct the Microbiology team and ensure all activities are in line with agreed SOPs
    • Act as subject matter expert for Microbiology and review/enable documents (SOPs, Validation Protocols) on behalf of the Microbiology team
    • Provide appropriate solutions to current and future compliance risks
    • Ensure the testing of products and materials are both on time and conform to SAP lead times
    • Manage CAPAs, non-conformances, change controls and customer concerns
    • Direct audits on CROs conducting outsourced Microbiology activities
    • Communicate any legislative and guideline changes issued by Health Authorities to the Microbiology team
    • Act as a representative for both internal and external quality audits, ensuring recommendations are quickly implemented
    • Be involved in meeting company objectives including KPIs
    • Provide training and mentorship to employees
    • Budget management for the Microbiology team


    Qualifications:

    • Scientific degree
    • Project and people management experience within a pharmaceutical company
    • Experience with MHRA audits and both internal and external audits
    • Experience in Aseptic Environmental Monitoring
    • Strong knowledge of product licensing activities and EU Regulatory guidelines


    Skills Alliance is exclusively partnered with this quality driven pharmaceutical company. Please click APPLY or call Karina Sharipova at +44 (0) 207 220 6205 to receive further information, including a full job description.

  • UK

    £450 - £600 per day
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    I am currently working with a mid-sized biotech company specialising in cancer treatment for patients.

    My client is looking for a Regulatory Manager for a 12-month period.

    Contract: 12-months

    Rate: £450 – £600 per day (dependent on experience)

    Hours: Full-time

    Location: London

    I have outlined the job description below:

    • The role has a focus on the management of all maintenance activities for open CTAs in Europe
    • This person will manage any new CTA applications for the EU that may come up during the duration of the contract
    • Experience in Oncology and with biologics

    Please let me know if this would be of interest for you?

    Contact me:

    shakir.hossain (at) skillsalliance.com

    +44 (0) 207 220 6232

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    A Leading global Pharmaceutical company are recruiting for a Senior Manager Global Quality Operations in Hertfordshire.

    This is a unique opportunity to improve the company’s quality systems, inspection management, regulatory intelligence activities and many more.

    Responsibilities:

    • Pharmacovigilance Audits – Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities

    • Plan, supervise, conduct, and support internal and external GxP audits

    • Maintain a tracking tool for audits, findings and corrective and preventive actions

    • Quality System

    • Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’

    • Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV.

    • Collaborate with the respective Functional Area Heads/representatives

    • Ensure SOPs/ WPs are compliant with applicable requirements and regulations

    • Support the preparation for GxP inspections

    • Support the responses to Regulatory Authorities

    • Regulatory Intelligence – Maintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of the company’s procedures.

    Requirements:

    • Degree in natural science or equivalent number of years’ experience

    • Experience in Pharmacovigilance auditing (Qualification as an auditor preferred)

    • Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation

    • Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance

    • Experience in Monitoring, Quality Assurance and/or Good Clinical Practices

    • Exposure to inspections

    This Senior Manager Global Quality Operations position is an office-based position. It Is a permanent role offering a competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details at
    0203 668 3961 or click APPLY NOW

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    Would you be interested in working with a leading global CRO company as a Regulatory Affairs Associate in West Sussex. You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing International Regulatory Affairs team with an impressive clientele list.. The rapid growth of the company is accompanied by excellent career progression opportunities

    Responsibilities:

    • 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.
    • 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.

    Requirements:

    • 6 – 12 months of industry experience in a Regulatory environment
    • Science graduate

    This Regulatory Affair Senior Associate position comes with a competitive basic salary + benefits

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • UK

    £30000 - £35000 per annum, Standard Benefits (inc bonus)
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    Skills Alliance are recruiting on behalf of a global pharmaceutical organisation, currently experienced significant change amidst a period of accelerated growth. They are seeking an experienced Inventory Control Coordinator to join their Supply Chain organisation on this journey.

    Job Role:

    • To support the supply chain planning department with the coordination of administrative tasks and ensure inventory is up to date by performing production consumption and month end reconciliation

    Key Responsibilities:

    • Abilify Maintena Component demand forecast preparation
    • Organising shipments of components from suppliers to packaging sites
    • Working via the existing processes within SAP B1
    • Testing support where needed
    • Preparation of sales orders to enable invoicing
    • Goods receipting of purchase orders
    • Rescheduling and aligning purchase orders against dates agreed by suppliers
    • Receiving of purchase orders into Arvato Distribution Centre ensuring all data is correct in SAP B1
    • To assist with booking shipments into Arvato Distribution Centre by raising stock transfer orders in a timely manner
    • Ensuring correct documentation accompanies shipments
    • Raising invoices for shipments to Canada
    • Physical movement of stock
    • French hospital orders
    • Supply Chain inbox categorisation
    • Month end tasks
    • Ad hoc supply chain tasks

    Experience and Required Competencies:

    • Previous Inventory control coordination experience in a fast-paced supply chain environment.
    • Administration experience, such as invoicing and placing purchase orders.
    • Excellent attention to detail.
    • Ability to work under pressure in a fast-paced environment to meet deadlines.
    • Challenging and strong administrative roles.
    • Numerical and data analysis skills required.
    • Good verbal and written communication skills.
    • Sensitive to different cultures and working across multi-language groups.
    • High level of customer service.
    • Previous use of SAP B1 desirable.
  • UK

    £30000 - £38000 per annum, Bonus
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    Skills Alliance are recruiting on behalf of a global pharmaceutical organisation, currently experienced significant change amidst a period of accelerated growth. They are seeking an experienced Supply Chain Planner to join their organisation on this journey.

    Job Role:

    • Maintain precise knowledge of customer orders, demand forecasts and inventory levels in order to plan and administer the supply of product to meet agreed customer service levels, whilst achieving inventory targets, minimising obsolescence and managing all supply chain aspects of changes to finished product presentations. The role requires working closely with the Packaging site and QA department.
    • Support Supply Chain projects, as required.


    Key Responsibilities:

    • Work with affiliates, 3rd-party customers and contract packaging sites to agree feasible supply schedules for finished pack products to meet market demand.
    • Routinely process customer orders
    • Create and place Bulk orders internationally, based on replenishment demand forecast on finished packs and current inventory situation at the packaging Site, and track delivery to ensure arrival at packaging site.
    • Carry out formal S&OP with contract packaging site on a monthly basis, agreeing supply chain plans.
    • Establish available capacity at the contract packaging site to cover the agreed planning horizon.
    • Undertake capacity studies as required if shortage of Raw materials at contract packaging Site
    • Report production and shipping schedule attainment, inventory days on hand and projected & actual obsolescence of finished products and bulk tablets.
    • Highlight areas of concern and contribute to supply chain activities necessary to implement corrective actions.
    • Seek and adopt opportunities to improve own working methods and practices.
    • Make appropriate observations relating to potential improvements in overall business processes, material/ information flows and working practices.
    • Highlight need for improvement activities to occur in other areas of the business that impact supply chain.
    • Liaise with Finance group to report provisional and actual write offs.


    Required Experience:

    • Proven experience as a supply chain planner in a fast-paced, pharmaceutical or FMCG environment.
    • Ability to manage a complex product portfolio.
    • Ability to take the lead and set a high standard for working practices for other team members.
    • Working knowledge of supply chain practices and demand planning.
    • Appreciation of regulatory compliance issues.
    • Interpersonal competencies such as excellent communication skills, both within company and with third parties.
    • Understanding of commercial aspects when dealing with third parties and the importance of confidentiality of information.
    • Appreciation of the cross-functional nature of supply chain planning and the need to consider relevant stakeholders.
    • Attention to detail.
    • Excellent communication skills.
    • A proactive attitude, team player and relationship building skills.
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    Our client are an established Biotechnology organisation – A well-regarded name in the animal health industry. With a major R&D project outlined next year, they require an experienced procurement professional to lead procurement activities. Based in Edinburgh, this is an excellent, diverse role that will require someone ideally with an excellent knowledge within Biotechnology, has a strong track record in category areas such as Capital Expenditure / Capex, Logistics / Shipping or R&D.


    Job role:

    • To provide strategic, end-to-end tender process execution across a wide-range of various categories.
    • You will be required to manage multiple sourcing projects simulataneously, along with manage stakeholder relationships with key internal and external 3rd parties the business are seeking engagement with.


    Required experience:

    • A proven track record in executing strategic sourcing for bespoke capital expenditure / capex OR shipping categories. Additionally if you have experience across research and development categories in biotech or science-based industries, this will be advantageous.
    • Demonstrable achievements in executing end-to-end sourcing processes, delivering cost savings and performance improvements across a variety of focus areas.
    • Ability to engage a diverse stakeholder audience, up to C-suite and across technical R&D departments, both internal and externally.
    • Ability to work autonomously as the sole procurement contact within an organisation, achieving results in a relatively unstructured procurement process.

    An inital 3-6 month contract, this role will be based in Edinburgh however can provide flexible working as long as you are able to travel to Edinburgh for meetings and run workshops when required. This may also be available to the right candidate on a part-time basis, should you not be available for work for a full week due to other commitments.

    Please get in contact with Jim Bellicoso on jim.b.a4lgdx1gujnr@skillsalliance.aptrack.co, or apply via the advert to register interest.

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    Skills Alliance is currently partnered with a leading biotech company based in the northern part of Switzerland. For this purpose, our client is looking for a Project Manager Engineering to join their team on a 12 month rolling contract.


    **The role is open to re-locators (EU/EFTA Citizens) and French/German border commuters**

    REQUIRED QUALIFICATIONS AND EXPERIENCE:-

    • technical degree in engineering or architecture, further education in facility management would be an asset
    • comprehensive experience and skills in project management and construction management of demanding projects, ideally 5-7 years of experience
    • familiarity with complex lab and advanced office environments is an asset
    • experience in energy and building service management would be a plus
    • advanced skills in CAFM and CAD software solutions or similar software
    • good language skills in German and English
    • preferably familiarity within pharmaceutical environment


    RESPONSIBILITIES AND TASKS:-

    • project management and project supervising of internal construction and conversion projects
    • responsible for project planning and development (project specification such as UR, URS, description, evaluation of and liaison with external partners)
    • conduct negotiations with suppliers, sourcing and managing of contracts
    • project responsibility for quality, budget and schedule
    • coordination and supervision (possibly with external partners) of the several disciplines (e.g. HVAC, Sanitary, Electricity) from planning to acceptance of construction work
    • ensure quality of processes, data flows and project documentation
    • ensure implementation of company standards (e.g. HSSE, FM)within fields of responsibilities
    • Able to share expertise and experience with team members and across teams.


    If you are interested or you know someone who would be interested, please apply directly here or feel free to contact Heena Verma via phone @ +41 44 498 2410.

    Thanks!

  • UK

    £50000 - £60000 per annum, Strong Bonus + Extensive Benefits
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    A leading biopharmaceutical company is looking for a Clinical Records Manager to join their Clinical Operations team. This is an excellent opportunity to join one of the pioneers in clinical drug development with a great reputation in the industry and an ever-expanding and exciting pipeline.

    The role will require international travel on a quarterly basis to meet the client’s provider and liaise with senior stakeholders globally.

    Ideally, you will be experienced in clinical trial documentation from a strong CTA or TMF/eTMF background. If you have experience in QC that would be an advantage.

    This is a permanent, office-based role in London with 2 days working from home. International travel expenses will be provided by the client.

    Skills Alliance are the preferred suppliers for this role. Please contact Arturo Maldonado on 02036683963 for more information. Alternatively, click APPLY NOW.

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
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    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
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    Share

    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
    Apply

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


    Share

    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
    Apply

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


    Share

    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
    Apply

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


    Share

    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
    Apply

    Job
    Application

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


    Share

    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    Competitive Salary and benefits package
    Apply

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    Skills Alliance has been exclusively retained by a specialty pharmaceutical company to hire a Microbiology Manager, to provide leadership and guidance to the function as they prepare for an FDA audit later this year.

    Our client is committed to delivering specialty CNS products and enjoys both global and national partnerships with healthcare providers and facilities. The Microbiology Manager will be part of the FDA readiness project team and will act as the head representative for inspections. The role is highly visible and will be the subject matter expert, reporting to the UK Quality Director.

    The Microbiology Manager will facilitate the compliance of appropriate GMP/GLP requirements, provide Microbiology support to the Quality team in the event of an environmental excursion and mitigate current and future compliance risks. Experience with MHRA inspections is a must, with FDA inspection experience desirable.

    Job Responsibilities:

    • Lead and direct the Microbiology team and ensure all activities are in line with agreed SOPs
    • Act as subject matter expert for Microbiology and review/enable documents (SOPs, Validation Protocols) on behalf of the Microbiology team
    • Provide appropriate solutions to current and future compliance risks
    • Ensure the testing of products and materials are both on time and conform to SAP lead times
    • Manage CAPAs, non-conformances, change controls and customer concerns
    • Direct audits on CROs conducting outsourced Microbiology activities
    • Communicate any legislative and guideline changes issued by Health Authorities to the Microbiology team
    • Act as a representative for both internal and external quality audits, ensuring recommendations are quickly implemented
    • Be involved in meeting company objectives including KPIs
    • Provide training and mentorship to employees
    • Budget management for the Microbiology team


    Qualifications:

    • Scientific degree
    • Project and people management experience within a pharmaceutical company
    • Experience with MHRA audits and both internal and external audits
    • Experience in Aseptic Environmental Monitoring
    • Strong knowledge of product licensing activities and EU Regulatory guidelines


    Skills Alliance is exclusively partnered with this quality driven pharmaceutical company. Please click APPLY or call Karina Sharipova at +44 (0) 207 220 6205 to receive further information, including a full job description.

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    A Leading global Biopharmaceutical company are recruiting for a Regulatory Affair Manager/ Senior Associate position.

    This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability. They work in a range of area specialising in Cell Therapy and Oncology.

    Responsibilities:

    • Working with the European regulatory product lead for a development product, prepares regulatory documentation as required, in accordance with Regulations, guidance and legal obligations
    • Preparation and co-ordination of the regulatory documentation to support clinical trial applications and amendments, in the European Union
    • Working with the European regulatory product lead to ensure when licensed the product packaging and associated information is updated and maintained in accordance with Marketing Authorisation including the review and management of labelling translations and artwork
    • Interaction with the Regulatory, Clinical Research, Clinical Operation and other function to ensure optimal execution of the agreed regulatory strategy for development medicinal products.

    Requirements:

    • Experience in the preparation and submission of Regulatory documentation to support centralised MAA procedure and post approval activities
    • Knowledge and experience relating to clinical trials and clinical trial applications
    • Good breadth of understanding of the European regulations
    • Experience representing Regulatory Affairs on cross functional teams is desirable
    • Degree in biological or life sciences, pharmacy or medicine (or international equivalent)

    This Regulatory Affair Manager/ Senior Associate is a permanent role offering around £50-60K + benefits, office based in Cambridge or Stockley Park with flexibility.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details click APPLY NOW

  • UK

    £55000 - £60000 per annum
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    Share

    Would you be interested in working with a leading global CRO company as a Senior Regulatory Affairs Associate in West Sussex. You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing International Regulatory Affairs team with an impressive clientele list.. The rapid growth of the company is accompanied by excellent career progression opportunities.

    Responsibilities:

    • 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.
    • 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.

    Requirements:

    • 4 – 5 years of Regulatory experience
    • Good of understanding of all aspects of CTA submissions
    • Expert knowledge of ICH-GCP and local regulatory agency and ethics committee regulations and requirements
    • Science graduate

    This Regulatory Affair Officer position comes with a competitive basic salary of up to 60K + benefits and 40% home working (2 days per week).

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • UK

    £45000 - £50000 per annum
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    Would you be interested in working with a leading global CRO company as a Senior Regulatory Affairs Associate in West Sussex. You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    Responsibilities:

    • Management, preparation and submission of EU CTAA
    • Tracks, reports and files CTAA and amendment submission/approval progress in eTMF and CTMS
    • Participates in quality control
    • Serves as a key Regulatory liaison on behalf of the company

    Requirements:

    • At least 2 – 3 years’ experience in relevant fields
    • Good breadth of understanding of all aspects of CTA submissions
    • Oncology experience
    • A Bachelor’s degree in life sciences
    • Strong analytical and communication skills

    This Senior Regulatory Affairs Associate role is an office-based position in West Sussex. It is a permanent role offering an attractive salary between £45,000 – £50,000 + benefits per annum, depending on experience.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

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    A leading European specialist pharmaceutical company are currently recruiting a Regulatory Affairs Manager in medical devices located just outside North West London.

    The role requires a Regulatory Affairs Manager with a background in medical devices to be responsible for developing the regulatory vision for assigned products in order to deliver against the company’s global product strategy and vision.

    Responsibilities:

    • Keep strategic oversight of regulatory changes that impact assigned products, ensuring that regulatory projects are organised in alignment with the product vision
    • Maintain up to date knowledge of relevant regulations, guidelines and industry standards, advising as to their interpretation and propose strategies for effective implementation
    • Identify potential changes that are being discussed in cross functional meetings and feed these into Regulatory Change Triage for assessment and inclusion within the long-term planning of workload
    • Integrate new products into operational plans, ensuring that product visions are understood, and regulatory strategies are put in place, so that routine maintenance can be handed over to Regulatory Change Leads
    • Mentor and advise Regulatory Change Leads and delivery team members to ensure that the planned regulatory strategies are followed and any roadblocks that require product or regulatory expertise are resolved and escalated as necessary
    • Co-ordinate QMS related regulatory activities e.g. CAPA’s as applicable, to ensure compliance with actions
    • Support inspections and audits, as applicable

    Requirements:

    • Minimum BSc and MSc or PhD or PharmD or M.D. in science or healthcare preferred or equivalent relevant experience
    • Must have demonstrable experience managing product portfolios within a Regulatory Affairs global position.
    • Considerable regulatory experience with EU regulatory requirements and processes (MRP, DCP and CP) for post approval activities. Experience with AU and NZ preferred
    • Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook
    • Aspires to continuously develop technical/professional knowledge and interpersonal/management expertise to be a good role model

    This Regulatory affairs manager position is a office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • UK

    Excellent Salary + Car Allowance + Strong Bonus and Benefits
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    A leading global pharmaceutical company is looking for a Senior clinical program manager to join their exciting clinical operations team. You would be working on a multitude of European trials mostly across complex oncology and cancer therapy areas.
    This is an excellent opportunity for an experienced clinical programe manager to expand their leadership experience in a senior position within a dynamic organization.

    Key Responsibilities:

    • Manage all aspects of assigned global trials within designated program budgets and timelines
    • Provide program-level oversight to vendors, such as CRO, central lab, and imaging
    • Protocol development, feasibility, set-up and conduct.
    • Directly line manage a small clinical team, including recruit, hire, mentor and management.
    • Travel may be required occasionally to Europe

    Key Requirements:

    • Clinical project and programe management experience
    • Oncology experience essential
    • Solid line management experience including management and mentoring of junior staff
    • Strong vendor management and project oversight experience

    Skills Alliance are the exclusive suppliers for this role. A full job description is available on request. Please contact Arturo Maldonado on 02036683963 for more information, or alternatively click APPLY NOW

    Please note if you have not heard back on your application within 48 hours then unfortunately you have been unsuccessful on this occasion.

  • UK

    £40000 - £50000 per annum, 2x yearly bonus + extensive benefits package
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    Share

    A specialist and niche patient recruitment company are looking for a manager to join their exciting and ever-growing patient recruitment team.

    This is an excellent opportunity to join a fast-paced and friendly patient recruitment company in clinical research who work closely with their extensive CRO and pharma clients

    The role is Office-based in Hertfordshire, but there could be home-based consideration. This is a permanent position on a full-time basis.

    Key responsibilities:

    • Managing patient recruitment and retention programmes for projects for main clients and in-house staff
    • Management of third-party vendors
    • Involvement in budget management
    • Active role in business development activities

    Key Requirements:

    • Extensive experience in patient recruitment or deriving patient recruitment strategies, can be in industrial or a healthcare setting
    • Experience working with numerous stakeholders on multi-regional project
    • Degree in life sciences
    • Proficient in Microsoft package

    Skills Alliance are the preferred suppliers for this role. For more information please call Arturo Maldonado on 02036683963 or alternatively click APPLY NOW.

  • UK

    Competitive Salary + Bonus + Benefits Package
    Apply

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    Share

    A global CRO are looking for a study-start up associate to join their dynamic clinical operations team. This is an excellent entry opportunity to join a leading organisation focused primarily in Oncology clinical studies. Although a small organisation, they have a strong reputation worldwide for their work in early phase studies (I-II), and support emerging biotechs and global pharma companies to identify the most promising cancer therapies.

    Key requirements:

    • Recent life-science graduate
    • 6 month industry experience in associate roles such as a CTA would be an advantage.
    • Those with a clinical background if shorter are also encouraged to apply!

    This is a permanent, full-time, office-based role in Crawley. A full job specification and package details are available on request.
    This role offers excellent long term prospects in clinical operations and can kickstart your career in the industry.

    Skills Alliance are the Exclusive partners for this role. Please contact Arturo Maldonado on 0203 668 3963 for a confidential discussion. Alternatively, click APPLY NOW.

  • UK

    £35000 - £38000 per annum
    Apply

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    Share

    Are you people orientated with a desire to engage and interact?

    Are you able to work think creatively in order to achieve your tasks?

    Do you enjoy accomplishing tasks that ultimately allow for more effective working?

    I am currently partnering with a Global Pharmaceutical company that are looking to appoint an EA to a Senior level Executive member within the organisation.

    The individual you’ll be supporting is very much about engagement, consistently delivering, is passionate about what the organisation are doing and ensuring that the employees are aligned with the values of the company.

    With that in mind, it is essential that the right person for this role has the ability to work in a adaptable manner, consistently working towards improvement and enabling this individual to deliver further to the wider organisation through assisting with event management, training, diary management, administrative tasks and related duties.

    This role will extend to assisting in the wider HR team, who are all individually unique people working collectively to create a dynamic working environment, so culture fit is an essential factor for them when bringing someone into the business.

    This is a permanent full-time position where they hope to appoint someone at the beginning of the New Year.

    Skills Alliance are a preferred supplier to this company. If you are interested in discussing this position and how you can become a part of this forward thinking organisation, apply now.

  • UK

    Strong Competitive Salary + Car Allowance + Excellent Bonus & Benefits
    Apply

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    Share

    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    Strong Competitive Salary + Car Allowance + Excellent Bonus & Benefits
    Apply

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


    Share

    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    Strong Competitive Salary + Car Allowance + Excellent Bonus & Benefits
    Apply

    Job
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    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

    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    Strong Competitive Salary + Car Allowance + Excellent Bonus & Benefits
    Apply

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


    Share

    My client is a leading global CRO that are looking for a CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Minimum of 1-year independent monitoring as a CRA
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

  • UK

    £50000 - £60000 per annum, 15% Bonus + Benefit Package
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    A leading European specialist pharmaceutical company are currently recruiting a Regulatory Affairs Data Manager located just outside of North West London.

    The role requires a Regulatory Affairs Data Manager with oversee the day to day management of Regulatory Affairs Core Data, XEVMPD and IDMP data. In addition to maintain subject matter expertise regarding RA data legislation, guidelines and requirements.

    Responsibilities:

    • Keep up to date on RA data legislation, including IDMP. Communicate changes to ensure RIMS Steering Committee and other key stakeholders are kept well informed of the impact to the company.
    • Participate in industry forums on data legislation. Identify and anticipate impacts of changes to RA data legislation, including IDMP
    • Act as a SPOR Super User for the company, ensuring that SPOR processes are followed and the companies data is kept up to date within SPOR
    • Ensure controlled vocabularies and referentials are aligned within SPOR and applied consistently across RA systems. Ensure that changes are implemented according to best practise for data quality and standards.
    • Provide RA data expertise in support of data governance policies at the company and carry out required data governance activities
    • Provide subject matter expertise to support the creation of training and educational material and deliver initial training
    • Create and maintain RA data management processes, procedures and work instructions. Support continuous improvement of data and processes, collecting feedback from users and acting as Veeva RIMS SuperUser

    Requirements:

    • Bachelor’s degree in Computer Science, Business Administration, or related technical field or equivalent experience.
      • Significant business systems / business process experience, with demonstrable experience in a regulatory affairs/Regulatory Operations/Clinical Operations environment. Experience in Manufacturing is desirable.
      • In depth knowledge and understanding of pharmaceutical science processes and standards including XEVMPD, ISO IDMP, EMA SPOR, Pharmacopeia, Standard Terms/Referential, CMC and regulatory dossier lifecycle, MedDRA codes, etc.
      • Deep understanding of the ISO IDMP data model and ability to interpret and articulate this model and legislative requirement to key stakeholders.
      • Experience and understanding of the use of electronic data management systems, such as regulatory publishing systems, regulatory or clinical tracking databases, and ideally, also in manufacturing inventory systems

    This Regulatory affairs Data manager position is an office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

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    An exciting growing Biotech company are currently recruiting for a Regulatory Affairs Manager for a 12-month fixed term contract located in London. This is an opportunity to work on innovative and pioneering products across the company’s portfolio. The Regulatory Affairs Manager will be part of the broader regulatory affairs team with responsibilities for planning, preparing, reviewing and submitting regulatory applications to health authorities globally.

    Responsibilities:

    • To support cross-functional teams e.g. Research, Pre-Clinical, Manufacturing, Clinical Operations and liaise with external providers to ensure high quality and timely regulatory submissions;
    • To ensure ICH GCP compliant reviews for technical documents e.g. protocol, IB, IMPD, ICFs, label texts etc. and or engage in technical authoring where required;
    • To provide regulatory project management for various gene therapy products from early to late stage clinical development;
    • To plan, prepare, review, submit and track submissions, including Clinical Trial Authorisations, amendments, scientific advice meeting packages, breakthrough/PRIME designation, orphan drug applications and paediatric investigational plans;
    • To ensure appropriate and correct procedures are following with regards to Advanced-Therapy Investigational Medicinal Product (ATIMP) therapies and stay abreast of international requirements;

    Requirements:

    • Extensive experience with Clinical Trial Authorisation (CTA) applications and maintenance submissions in Europe, with US IND experience advantageous
    • Ideally experience in Oncology or Gene therapy
    • Preparing Scientific Advice meeting packages
    • Significant experience in Regulatory Affairs (minimum 5 years)
    • Bachelor’s degree in Life Science

    This 12-month FTC Regulatory Affair Manager position comes with a competitive salary + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

  • UK

    £50000 - £60000 per annum, Strong Bonus and Extensive Benefits Package
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    A leading Biopharma in London are hiring for a Clinical Project Manager to join and manage trials in their exciting late-phase unit. The role would be working and managing trials in this area across a variety of different therapeutic areas and working on their vast and extensive pipeline.

    Key Responsibilities:

    • Provide support and oversight of Investigator Sponsored Trials including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required.
    • Manages aspects of assigned international post-authorisation studies within designated program budgets and timelines.
    • Contributes to development and maintenance of study budgets.
    • Contributes to development of RFPs and participate in selection of CROs/vendors.
    • Manages CROs/vendors for assigned post-authorisation studies.
    • Communicates project status and issues and ensure project team goals are met.
    • Contributes to the writing and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans and clinical study reports.
    • Maintains study timelines and communicates adjustments where necessary.
    • Develops good working relationships with the organisation’s late phase operational team and cross- functional staff internationally as required.

    Key Requirements:

    • The role would require someone with a project management background that has experience working on non-interventional studies (NIS) as well as late phase trials from phase III and IV.
    • Therapeutic area isn’t a specific requirement, but the management of trials in NIS is essential.
    • Working on PASS studies; Investigator lead trials or Compassionate Use Trials would also be a strong advantage
    • Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies.

    Skills Alliance are the preffered suppliers for this role. A full job description is available on request. For more information please contact Arturo Maldonado on +44 203 668 3963 or alternatively click APPLY.

    Please note if you do not recieve a response within 72 hours then unfortunately you have be unsuccessful on this ocassion.

  • UK

    £40000 - £50000 per annum
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    Would you be interested in working with a leading global CRO company as a Quality Assurance Specialist in West Sussex? You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing team with an impressive clientele list. The rapid growth of the company is accompanied by excellent career progression opportunities.


    Responsibilities:

    • Maintain the company’s QMS in line with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)

    • Provide advice on the improvement of GCP and GMP compliant clinical trial systems

    • Manage SOPs

    • Coordinate audits and inspection visits

    Requirements:

    • 2+ years of relevant QA experience with clinical research

    • GCP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal skills

    This Quality Assurance Specialist position comes with a competitive basic salary + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

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    Process Engineer with emphasis on pilot manufacturing of pharmaceutical products, transfer from R&D to GMP Manufacturing.

    Role focus:

    • Process modelling and analysis, process instrumentation, process scale up planning, data analysis, familiarity with pharmaceutical product analysis, familiarity with GMP/ICH requirements for process implementation.
    • Hands on assistance with process development with R&D partners and GMP implementation of proprietary pharmaceutical products with manufacturing partners.
    • Ability to travel often but based in UK (non-travel work can be performed from home).

    If you are interested please submit your CV and I will contact you with further information.

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    A leading European specialist pharmaceutical company are currently recruiting a Regulatory Change Lead / Project Manager located just outside of North West London.

    The role requires a Regulatory change lead / Project manager to be responsible for the project management of assigned post approval regulatory activities. This includes; forming and leading the delivery team through the planning of assigned projects: ensuring that high quality documentation is prepared for regulatory submissions in partnership with our Regulatory Service Providers: liaising with relevant departments and third parties to ensure regulatory requirements for these submissions are met.

    Responsibilities:

    • Organise kick-off meetings as required for assigned projects, engaging the relevant team members to plan and implement the change
    • Prepare and agree plans for implementation of regulatory activities within agreed timelines for change control
    • Work in collaboration with the Regulatory Affairs Managers to understand and align with agreed product strategies
    • Ensure that high quality documentation is prepared for submission following current best practice standards and meeting requirement guidelines
    • Anticipate and resolve complex regulatory issues, engaging Regulatory Affairs Manager as required
    • Ensure any post approval commitments are logged and followed up on
    • Liaise with relevant internal departments and external contacts to ensure regulatory requirements are met and to proactively communicate with regulatory authorities where required in order to expedite approval of submissions

    Requirements:

    • Excellent verbal and written communication skills, proficient presenting complex projects in a relevant and meaningful way to others.
    • Good degree in a relevant life science subject or equivalent Project Management qualification with demonstrable experience working within the Pharmaceutical sector and in a regulatory environment.
    • Strong facilitation skills, with the ability to coordinate a multi-disciplinary team to deliver against agreed plans
    • Proven ability to project manage multiple small and large projects within the regulatory affairs environment

    This Regulatory Change Lead / Project manager position is an office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

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    A leading European specialist pharmaceutical company are currently recruiting a Medical Device Expert located just outside of North West London.

    The Medical Device Expert would be responsible for activities requiring in-depth knowledge of regulations and regulatory requirements in relation to Medical Devices post CE approval, as well as assessments of Medical Devices and In-vitro Diagnostic and Active Implantable Medical Devices.

    Responsibilities:

    • Maintain up to date knowledge of relevant regulations, guidelines and industry standards, proactive communicate to internal stakeholders in writing and presentations to disseminate and discuss the interpretation and implementation
    • Provide expert advice and support to Brand Teams, cross functional Medical Device project team, and other area of the business, and communicate any changes required to Medical Devices RA Manager
    • Provide expert advice and support to due diligence activities as requested
    • Explore opportunities for continuous improvement to enhance business performance
    • Interrogate and sanity check audit preparation and participate in internal and external audits to ensure and sanity check successful re-certification of products.
    • Provide training of Medical Device cross functional project team members in Medical Device requirements as deemed relevant

    Requirements:

    • Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook
    • Able to contribute to budget preparation and review
    • BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
    • Must have expertise in the development, certification and maintenance of medical device products
    • Clear communicator, sharing information to ensure successful partnering with internal and external stakeholders. Listens and responds effectively to others
    • Responds quickly and positively to customer needs, develops effective collaborative working relationships with customers/external partners

    This Medical Device Expert position is an office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

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    I am working with a Global Pharmaceutical company who work on researching, developing, manufacturing and marketing of innovative products. They are currently looking for a QA Compliance Specialist to join their UK team to contribute to the maintenance of the quality system in order to ensure that QA and Regulatory compliance activities are fully adequate.

    Responsibilities of the role will fall into three different categories:

    Quality Assurance

    • Develop and maintain the quality management system to assure compliance with GMP and GDP
    • Plan, implement and perform internal quality audits
    • Monitor and report on product non-conformities
    • Manage and maintain systems for change control, deviation and CAPA
    • Manage and maintain a system for product complaint handling ensuring timely completion and reporting. If necessary, assist in any product recall
    • Collect, collate and compile data for periodic product quality reviews, including preparation of reports
    • Assist in conducting external/supplier audits as required
    • Review batch release documentation and coordinate correction of any errors
    • Assist in maintaining the system for document control, so that the current local and regional SOP systems are managed both in hard copy and electronically
    • Maintain documentation archiving systems
    • Prepare and maintain GMP documentation such as standard operating procedures
    • Conduct training sessions on QA systems as required
    • Contribute to Global Quality goals, projects and initiatives
    • Processing of Product Returns forms including usage decision

    Quality Control

    • Provide support in the planning and scheduling of laboratory testing
    • Initiate follow-up action on out of specification materials
    • Liaise with contractors and the laboratory on sample quantities and sampling frequency
    • Ensure stability testing is performed in accordance with the requirements of the marketing authorisations

    Regulatory

    • Provide support and advice relating to the manufacturing and technical content of the Company’s product licences and submissions
    • Ensure that the requirements and conditions of the Company’s product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures.

    Please submit your CV if you are interested in finding out more about the role.

  • UK

    £30000 - £40000 per annum
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    Quality Systems Associate

    This is a great opportunity to join a global, mid-sized leading pharmaceutical company, currently recruiting for a Quality Systems Associate.

    You would be part of a global, well-established and well-known Pharma organisation, which specialises in neurology and oncology. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the company’s vision within the healthcare industry.

    Responsibilities:

    • To support QMS Indicator reports

    • To coordinate GMP training

    • To support improvements to TrackWise processes and systems

    • To support the Deviation System

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Good technical and analytical judgment

    • Ability to maintain a professional behaviour

    • Excellent communicator

    This is an office-based position based in North London. It is a permanent role offering a competitive salary between 30K-40k, depending on experience.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • UK

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Trial Manager or 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 Study Manager, this would be working on interesting early phase studies. They require 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 55-65K depending on experience + bonus + extensive benefits.

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

  • UK

    £50000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager role based in West London and working in cell and gene therapy, specifically in Oncology.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Oncology team to work in Cell Therapy. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager or Junior Study Manager to join the team, this would be working on studies at the cutting edge of science. Oncology experience is required.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work. They offer an excellent salary and package around GBP 50-65K depending on experience + bonus + extensive benefits.

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

  • UK

    £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.

  • UK

    £50000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager role based in West London and working in cell and gene therapy, specifically in Oncology.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Oncology team to work in Cell Therapy. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager or Junior Study Manager to join the team, this would be working on studies at the cutting edge of science. Oncology experience is required.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work. They offer an excellent salary and package around GBP 50-65K depending on experience + bonus + extensive benefits.

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

  • UK

    £70000 - £85000 per annum, excellent package + car allowance
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Program Manager role based in West London and working in cell and gene therapy, specifically in Oncology.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Oncology team to work in Cell Therapy. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Senior Study Manager or Program Manager to join the team, this would be working on studies at the cutting edge of science. Oncology experience is required and there would be line management responsbility.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work. They offer an excellent salary and package around GBP 70-85K depending on experience + car allowance + bonus + extensive benefits.

    Skills Alliance are the preferred partner for this Clinical Program Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Trial Manager or Clinical Study Manager role based in Hertfordshire AND/OR London 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 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 managing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire AND/OR London with flexibility to work from home. They offer an excellent salary and package around GBP 55-65K depending on experience + bonus + extensive benefits.

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