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  • £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.

  • £20000 - £27000 per annum
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    Quality Control Analyst

    This is a great opportunity to join a well-established Pharmaceutical firm, with an extremely strong culture and great opportunities for career progression.

    They are currently looking for a passionate QC Analyst to join their growing QC team and contribute to the development of a variety of medicines and healthcare products.


    Responsibilities:

    • Assisting with the Quality Control of raw materials

    • Working in accordance with prescribed guidelines

    • Working with different analytical techniques

    Requirements:

    • 1 year’s relevant experience in an analytical testing role

    • Experience working with HPLC and GC analysis

    • Excellent communication skills

    This is an office-based position based in Hertfordshire. It is a permanent role offering a competitive salary up to 25K, which can be discussed on the application.

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

  • £25000 - £35000 per annum
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    Microbiologist

    This is a great opportunity to join a European-based pharmaceutical company with global reach, currently recruiting for a Microbiologist position.

    You would be part of a well-established and well-known Pharma organisation and as the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Coordinate qualification and routine requalification in the sterile processes
    • Knowledge of sterile and aseptic technical processes
    • Developing analytical methods
    • Implementing CAPAs

    Requirements:

    • 3+ years of experience in leading investigations
    • HPLC, GMP, GLP knowledge
    • Bachelor’s Degree
    • Excellent interpersonal and communication skills

    This Microbiologist position is a permanent position and comes with a competitive basic salary. 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.

  • £26.79 per hour, PAYE Benefits
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    Skills Alliance are working with a global pharmaceutical company, currently undergoing an international transformation programme across various shared service functions. As part of this programme along with managing processes amidst the current pandemic, they are seeking a Payroll Management Specialist to join the business on an initial 3 month contract. You will be required to have experience of payroll oversight (e.g. NIC, tax codes etc) and knowledge of SAP/ NGA/ADP payroll systems.

    Job Purpose:
    To effectively manage and lead a team of payroll officers and facilitate the smooth running of the company’s Payroll Services and transition to NGA Payroll.

    Required Experience:

    • Experience of Payroll oversight e.g. NIC, tax codes etc.
    • Knowledge of SAP/ NGA/ADP payroll systems
    • Proven compliance expertise; to understand and comply with industry laws and relevant regulations
    • Demonstrable examples of ability to proactively promote best practice and knowledge sharing.
    • Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.
  • €60 - €100 per hour
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    Skills Alliance are working with an innovative Medical Device company, currently within the Research & Development phase. As part of their growth they are seeking a Senior R&D engineer to join the business on an initial 6-month contract. You will be required to have experience with class IIb and III implantable medical device (catheter experience preferred).

    Responsibilities:

    – Prototyping of proposed designs

    – Development and documentation of manufacturing processes to support new designs

    – Contribute to compliance with Design Control regulations

    – Supporting and guiding the clinical team

    – Proficiency in SolidWorks and CAD experience

    Please contact: Shakir Hossain
    Email: shakir.hossain (at) skillsalliance.com
    Phone: + 44 (0) 207 220 6232

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    A leading pioneering software medical device company are currently on the market for a VP of Regulatory Affairs. With the company within its pivotal moment in its history and following the launch of a new program, the VP would overlook and be accountable for the overall Regulatory Affairs function.

    Responsibilities:

    • Provide strategic vision, expertise and leadership in the development of products and regulatory approval in the UK, Europe, US and then worldwide.
    • Responsibility for the company’s compliance with regulatory agencies and all applicable standards worldwide
    • Input as needed into the clinical studies required for Regulatory Approvals. Conversant in the key aspects and able to work with in-house and external experts in medical statistics, clinical study design, and data analysis.
    • Provide training and interpretation of FDA and other regulatory issues across the company more generally
    • Be responsible for the review and approval of promotional, advertising, and labelling items as and where necessary
    • Lead the Compliance to the Medical Device Directive (MDD) in the EU, FDA, and other regulatory agencies.

    Requirements:

    • Demonstrate significant regulatory experience and strategic thinking in novel situations.
    • Proven experience of achieving regulatory approvals for Software as a Medical device in the EU and USA.
    • A commercial focus in the application of regulatory requirements.
    • Outstanding communication skills, both verbal and written, and the ability to interface effectively with software engineering, operations, sales and marketing, and a wide range of other stakeholders
    • Bachelor’s or higher degree, preferably in life sciences, engineering, or business desirable

    The VP of Regulatory Affair is a permanent role offering a competitive salary and benefit package located in Cambridge.

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

  • Rate on application
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    A global pharmaceutical company are recruiting for a Payroll Specialist based in South East England, Surrey. This is an opportunity to join a reputable pharmaceutical company that are undergoing significant changes with a large underdoing project. They are looking for a contractor to manage and lead a team of payroll officers and facilitate smooth running of company’s payroll services with the following respomnsibilies:

    Responsibilities:

    • Payroll – Manage relationship with current Payroll Provider and ensure a successful implementation of new payroll with NGA
    • Manage UK Payroll Team on review, improving process and policies.
    • Guide and support the team on the process, dealing with issues and queries.
    • Ensure team meets key deadlines on annual timetables and compensation activities.

    Requirements:

    • Must have NGA knowledge and experience
    • Experience of Payroll oversight e.g. NIC, tax codes etc.
    • Knowledge of SAP/ NGA/ADP payroll systems
    • Proven compliance expertise; to understand and comply with industry laws and relevant regulations

    This role is an office-based position in South East England. It is a 3-month contract role on an competitive hourly rate.

    Skills Alliance are the preferred supplier for this role. Please contact Gena Mazreku for more details on +44 207 220 6216 or click APPLY NOW.

  • €600 - €800 per day
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    I have a unique opportunity to join developing biotech focused on cell therapy as an Interim Associate Director of Clinical Operations.

    This is an office-based position located 30 minutes South of Brussels.

    They are looking for this individual to be responsible for the overall coordination of the clinical team and monitoring of daily activities to ensure the successful completion of clinical trials. Exposure and participation in the planning, implementation, monitoring and management of clinical trials in compliance with applicable regulations, ICH–GCP Guidelines and SOPs.

    Additionally to supports overall management of the department in collaboration with senior management. Reports to the VP of Clinical Development.

    Experience required:

    ▪ 10+ year’s relevant experience in clinical operations.
    ▪ Considerable depth of experience in clinical study management, monitoring, and developing study-related documents.
    ▪ Management experience required – will be responsible for a team of 12. ▪

    Must be french speaking I look forward to speaking with those interested.

    +44 (0)2072206235

    My email is (No spaces) jack . sinclair (@) skillsalliance . com

  • Competitive Pay
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    We are partnered with a forward thinking CRO in the Greater Seattle area in search of a Histology Technician. This company’s mission is to enhance human life through therapeutics, and they have a focus on animal welfare and the humane treatment of their animal models. This person will work on the preparation of quality tissue samples for histopathologic evaluation; identification of tissue samples for proper embedding orientation; microtomy skills; performance routine hematoxylin and eosin (H&E) staining procedures; knowledge of the use and maintenance of equipment used for the preparation of tissue samples and the ability to maintain a clean and orderly laboratory environment.

    Responsibilities

    • Maintain and document the use and maintenance of laboratory equipment
    • Microtomy daily
    • Performs paraffin tissue processing
    • Identifies required tissue sample orientation and performs paraffin embedding procedures
    • Uses microtomy skills in the preparation of routine (paraffin embedded) microscopic slides according to standard operating procedures and/or required by study protocols
    • Performs routine hematoxylin and eosin (H&E) staining as well as cover slipping microscopic slides

    • Requirements:
      Associate’s degree (AA), specializing in science, preferred
    • Work experience includes, but not limited to at least 1+ years laboratory experience and/or training HT (ASCP) eligible within one year of employment

    This position is moving quickly so do not hesitate to apply!

  • Competitive Pay + Benefits
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    Title: Medical Director

    Location: New Jersey

    I’m partnered with a boutique pharmaceutical company just launched in the US, who is a global leader in the treatment of iron deficiency anemia in humans and animals.

    With Global HQ in Denmark and a product recently approved by the FDA, they are now looking for a Medical Director who can help them grow in the U.S. Ideally, they would like this person to have experience in hematology or oncology and if you’ve expertise specifically within anemia that is a plus but not essential.

    Responsibilities/Requirements

    • Experience with teams/organizations expanding into new markets
    • Therapeutic area experience: Hematology or Oncology required
    • Experience within Anemia a plus
    • Exciting opportunity to grow a new division for a newly approved FDA product

    We’re moving very quickly with this role, please don’t hesitate to apply as soon as possible. Please also feel free to reach out directly to Christine.Erickson@skillsalliance.com.

  • Competitive Pay + Benefits
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    We are partnered with a growing Companion Diagnostics in Seattle, working on state-of-the-art technology, and revolutionizing cancer diagnostics and monitoring through their novel approach to Next Generation Sequencing. Their goal is to bring this technology to as many cancer patients at possible.


    They are looking to grow the team with a Regulatory Manager who has experience with medical devices, as they are on their way to FDA approval.


    Role and Responsibilities:

    • Evaluate proposed products for product classification and regulatory pathway.
    • Assess regulatory intelligence in the development of regulatory strategies.
    • Develop and maintain Regulatory Strategy/Plan.
    • Develop regulatory procedures and SOPs and participates in implementation.
    • Manage submission activities for a variety of device regulatory approvals including CE mark, US premarket approvals (PMAs), US Premarket Notifications 510(k), post-approval reports, export certificates, establishment registrations, and device listings.
    • Review labeling and promotional material.


    Qualifications and Skills:

    • Bachelor’s degree.
    • At least 6 years of direct experience in the diagnostic industry, including a minimum of 5 years of Regulatory Affairs experience.
    • Experience in writing and preparing Regulatory Documents required.

    This position is moving quickly so do not hesitate to apply!

  • Competitive Salary + Comprehensive Benefits
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    Location: Greater Boston Area

    We are currently partnered with a pioneering biosimilars company who are focused on making medications easily accessible across some of the greatest healthcare needs. They are looking to hire key leadership positions to help successfully launch their US business.

    In this role, you would be responsible for executing legislative and advocacy strategies in the US Congress, federal agencies and with other stakeholders This role requires someone who can think strategically while working in a hands-on manner, as well as someone who can engage both internal and external stakeholders.

    Requirements:

    • Bachelor’s Degree; Advanced Degree in healthcare/policy is strongly preferred
    • Minimum 10+ years of relevant experience. Minimum 3-5 years in a government body relevant to healthcare policy
    • Experience with lobbying trade associations, industry groups, and/or working on Capitol Hill or another legislative or administrative body
    • US specialty biologics and biosimilars experience preferred
    • Can travel domestically and internationally approximately 40% of the time

    We are moving very quickly with this role, so please do not hesitate to apply as soon as possible

  • Competitive Pay + Benefits
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    We are partnered with a Companion Diagnostic Company in Seattle that is transforming care for cancer patients by providing genomic analysis of the disease using non-invasive liquid biopsy methods. Their assay platform has been validated to detect all four major types of genetic alterations that cause cancer! They are seeking an experienced Senior Full Stack Engineer for their team. You’ll be architecting and developing essential software systems that support the IVD development and local R&D projects, as well as facilitate integration with clients and research partners. This is a great opportunity to work for an exciting growing company who will truly make an impact in people’s lives.

    • 5+ years professional experience in software development

    • Experience gathering requirements and user acceptance required

    • React and/or React Native based development

    • Full stack development in a serverless environment using AWS, AWS core services

    • REST API design and development using Node.JS Express

    • Git / GitHub Flow

    • TDD

    • Kanban and/or SCRUM type practice, Jira/Trello

    • Ubuntu / Amazon Linux flavorings

    We are moving quickly on this position so do not hesitate to apply!

  • Competitive Salary + Comprehensive Benefits
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    Location: Boston, MA

    We are currently partnered with a pioneering biosimilars company who are focused on making medications easily accessible across some of the greatest healthcare needs. They are looking to hire key leadership positions to help successfully launch their US business.

    In this role, you would be responsible for managing all channels of the market access, and establishing relationships with payers in the U.S. This role requires a true strategic thinker, as well as an individual who thrives in a hands-on, growing environment.

    Requirements:

    • Bachelor’s Degree; advanced degree in health management / business is strongly preferred.
    • Minimum of 10-15 years’ experience in US pricing / market access, commercial or finance in the pharmaceutical industry is required.
    • Strong knowledge of the U.S. managed markets including commercial and government payers as well as other channels like Specialty Pharmacies, ACOs, IDNs etc.
    • Can travel domestically and internationally approximately 50% of the time

    We are moving very quickly with this role, so please do not hesitate to apply as soon as possible.

  • Competitive Salary + Comprehensive Benefits
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    We are currently partnered with a Swedish-based Medical Technology company looking to revolutionize how ADHD is assessed and diagnosed. They are focused in on creating informed decisions, combining both subjective and objective data, allowing for a more accurate diagnosis.

    Looking to continue their mission, and secure clinical utility studies in the US that will strengthen the medical necessity for tests, they are looking for a Clinical Research Head to join their team. This role will be responsible for all ongoing Clinical Research projects, and ensuring their success.

    Requirements:

    • Extensive experience in Clinical Trials methodology and/or Neurodevelopmental Disorders
    • Global Clinical Trials Experience
    • Medical Device/Technology experience preferred
    • Documented capacity to write scientific reports and papers
    • Strong interpersonal and communication skills
    • Previous Leadership experience

    We are moving very quickly with this role, so please don’t hesitate to apply!

  • Competitive Salary + Comprehensive Benefits
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    I’m working a confidential search with a pioneering biotechnology company working to expand the human healthspan by slowing and reversing age related diseases. Working at the forefront of biotechnology and medicine, their main mission stands behind extending our health unburdened by the disease of aging.

    In this role would, you would play a crucial part in experimental design and execution, analysis and interpretation of data, and presentation of findings to the larger Discovery organization. You would have a truly important role in the critical selection of clinical development candidates.

    Requirements:

    • Bachelor’s degree in the Life Sciences with 6-10 years of scientific experience in the biopharmaceutical industry, a Master’s degree and 2-6 years of experience, or a PhD in a relevant research field
    • Direct experience in developing in vitro assays (both cellular and biochemical)
    • Preferred experience in primary cell culture and/or co-culture models
    • Preferred experience in antibody screening and discovery

    We are moving very quickly with this role, so please don’t hesitate to apply!

  • Competitive Salary + Comprehensive Benefits
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    We are confidentially partnered with a pioneering biotechnology company working to expand the human healthspan by slowing and reversing age related diseases. Working at the forefront of biotechnology and medicine, their main mission stands behind extending our health unburdened by the disease of aging.

    For this role, you will have strong experience in experimental design, tissue handling, immunohistochemistry and digital quantitative analysis of histological images all supported by a solid background in histological technique and theory.

    Requirements:

    • Bachelor’s or associate’s degree in medical technology, clinical laboratory, chemical, physical or biological science and at least 4 years relevant work experience.
    • Experience performing histological stains, IHC / IF, or ISH on mouse and human tissue utilizing both manual and automated platforms.
    • Experience with slide imaging and fluorescence microscopy.
    • Experience with image quantification and analysis.


    We are moving very quickly with this role, so please don’t hesitate to apply!

  • £30000 - £40000 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 visit

    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.

  • £30000 - £40000 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 visit

    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.

  • £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 late phase.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Late Phase team to work on a wide variety of trials. 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. The candidate would need phase III or phase IV experience and be interested in observational studies.

    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 preferred 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.

  • £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.

  • £70000 - £80000 per annum, excellent package
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    A very exciting opportunity to join a growing Biopharma. Permanent Late Phase Associate Director / Program Manager role based in West London offering an excellent salary and package.

    This exciting and innovative Biopharma have many products on the market and a very strong pipeline. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Program Manager or Associate Director, this would be working on a variety of late phase phase studies. They require a substiantial clinical trial management background, line management and strong and recent non-interventional trials experience.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work from home. They offer an excellent salary and package around GBP 75-90K depending on experience + bonus + extensive benefits.

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

  • £50000 - £60000 per annum
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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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    A Global Pharmaceutical company focusing on the manufacturing and distribution of Generics through the differing business arms allowing them to provide medicinal solutions from production through to supply chain.

    This organisation is currently going through some expansion plans, diversifying their portfolio and looking at new countries, in which to offer solutions to more patients.

    With this in mind they are currently looking to recruit a Senior QA Manager – Auditor with the following experience:

    • Work on internal/external GMDP audits covering Third-Party Manufacturers, Laboratories, Warehouse and Logistics.
    • Complete QTAs
    • Stability Report Reviews
    • Risk Assessments
    • Work with CMOs

    If this role looks to be of interest and you would like to have an informal conversation to discuss your current situation and whether this position aligns well with your career progression plans, please submit your CV and I will contact you with more information

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    Skills Alliance are currently partnered with a Global Specialist CNS Pharmaceutical company who is increasing their Manufacturing and as a result searching for an experienced QP to join their team.


    Key Responsibilities

    • Qualified Person as defined in Article 51 of 2001/83/EC
    • Responsible for ensuring that all medicinal products are manufactured to the requirements of EU GMP
    • MHRA and FDA Inspections
    • Lead internal/external quality audits

    Requirements

    • Knowledge of EU GMP, regulations and guidelines.
    • Managing QMS Systems
    • Experience in sterile and non-sterile dosage forms
    • BSc degree in Life Sciences.

    This Qualified Person position is a permanent position and comes with a competitive salary + benefits. Skills Alliance are the preferred supplier for this role. Please contact Stephanie Khalife for more details on +44 (0) 20 7220 6230 OR click APPLY NOW.

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    Skills Alliance is currently partnered with the leading global pharmaceutical company based in the UK. For this purpose, our client is looking for a Local Study Manager/Project Manager to join their team on a permanent basis.

    This is a permanent employment with a global mid-sized CRO and a 1 year contract (to begin with a possibility of extension) with the Sponsor (a leading global pharmaceutical company).

    Please refer Job Description below:-

    Must have Criteria/Requirements:-

    Experience in working managing studies for Oncology trials within the UK.
    Project Management experience is a MUST along with experience in managing CRA’s is also a MUST.
    Budget management experience is nice to have but is not a deal breaker.
    You should ideally able to be based in Luton office for 1-2 days per week – rest of the days is Home-office.

    Responsibilities:-

    • Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
    • Lead local study team(s) consisting of CRAs, lead CRAs (if Nordic countries outside Sweden participate in the study) and study administrator(s).
    • In collaboration with Line Manager(s):
      • Lead and optimize the performance of the local study team(s) at country level verifying compliance with AZ procedural documents, ICH-GCP and local regulations and to update other study team members on study matters
      • Lead development of local monitoring plan as per targeted monitoring guidance from respective study team.
      • Perform any required co-monitoring and QC visits with study monitor(s)
    • Contribute to review of monitoring visit reports and pro-actively advice the CRA(s) on study related matters.
    • Proactively identify and facilitate resolution of complex study problems and issues.
    • Organize regular local study team meetings on an agenda driven basis.
    • Actively work towards achieving good relationships with all local study team members.
    • Report study progress/update to the SMO study leader/team.
    • Contribute to patient recruitment strategy with monitors, including regular communication with concerned investigators as necessary.
    • Communicate and co-ordinate regularly with national coordinating investigator/national lead investigator on recruitment and other study matters.
    • Coordinate the process for selection of potential investigators considering capability, competence, etc. of the hospitals/sites.
    • Plan and lead national Investigator meetings, in line with local codes.
    • Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
    • Work in close coordination with study drug coordinator to create a robust drug consumption plan.
    • Oversee timely preparation of country SMA, country fSMA and country master CSA.
    • In collaboration with the local study team, verify completeness of the electronic trial master file and/or paper trial master file on country and site level, and confirm essential documents are sent to SMO/hub location/site.
    • Oversee timely submission of proper application/documents to EC/IRB.
    • Work together with regulatory affairs to see to timely delivery of proper application/documents for submissions to regulatory authority.
    • Set up and maintain the study in CTMS and/or other clinical trial management system, at study country level.
    • Confirm accurate payments related to the study are performed.
    • Participate in training and coaching new members of the local study team.
    • Verify that all study documents are ready for final archiving and sign-off completion of local part of the trial master file.
    • Plan and lead activities associated with audits and regulatory inspections in liaison with line manager, clinical process manager and CQM.
    • Provide input to process development and improvement.
    • Provide regular information to SMM Director and Associate Directs(s) at country level on studies and planned study milestones/key issues.
    • Update SMM Director and Associate Directs(s) about the performance of the CRAs/lead CRAs and CSAs in the local ST.
    • Confirm that study activities at country level comply with AZ’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
    • Assist SMM Director and Associate Directs(s) in efficient functioning of department at country level.
    • Prepare and maintain study budget at country level in ACCORD.
    • Liaise with local compliance officer and nominated signatory regarding payments to investigators to confirm these are in accordance with local requirements.
    • Timely preparation and support to process of registration of applicable clinical studies in country-specific or regional websites.
    • See that clinical and operational feasibility assessment of study design concept and clinical study protocol is performed to highest quality.
    • Support SMM region in initiatives as agreed with SMM Director and Associate Directs(s).

    If interested, or you know someone who would be interested please apply directly here or contact Heena Verma via phone: +41 44 798 2410.

  • £30000 - £40000 per annum
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    Quality Specialist


    This is a great opportunity to join a successful and rapidly growing pharmaceutical company, currently recruiting for a Quality Specialist.

    If you are looking for a more challenging role within a well-funded pharma company that will give you the opportunity to progress, this is it! As the company expands, you will have the capability to progress within your career, as well as contributing towards making a difference within the healthcare industry.

    Responsibilities:

    • To support Quality Operations in the warehouse

    • To review pharmaceutical product batch files

    • To provide QA support

    • To monitor Complaints, CAPA, Deviation and Change Control

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Previous experience working in a GMP environment

    • Enthusiastic and highly motivated

    • Excellent communicator

    This is an office-based position in Essex. It is a temporary 12-month contract role offering a competitive salary which can be discussed on the application.

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

  • £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.

  • £30000 - £40000 per annum
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    This is a great opportunity to join a pharmaceutical company with global reach, currently recruiting for a QC Analyst position.

    You would be part of a well-established and well-known Pharma organisation, which specialises in the treatment of addiction and critical care. As the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Carrying out analysis of finished products and stability batches

    • Working alongside the technical team

    • Developing analytical methods

    • Working according to GMP standards

    Requirements:

    • 2+ years of relevant experience

    • HPLC, GMP, GLP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal and communication skills

    This Quality Control Analyst position is a permanent position and comes with a competitive basic salary. 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.

  • £30000 - £38000 per annum
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    This is a great opportunity to join a European-based pharmaceutical company with global reach, currently recruiting for a QA Team Leader.

    You would be part of a well-established and well-known Pharma organisation, and as the company expands their manufacturing plans, you will have the capability to progress within your career, as well as contribute towards reaching the companies targets and vision.


    Responsibilities:

    • Oversee the quality of the entire product journey
    • Working alongside the Quality Systems Department
    • Generating the departmental KPIs as required by the business
    • Ensure that all staff members are trained and aware of the importance of GMP guidelines


    Requirements:

    • Previous managerial experience/ leading a team
    • Prior experience working with GMP and GDP standards
    • Previous managerial experience
    • Experience with regulatory GMDP audits
    • Excellent interpersonal and leadership skills


    This QA Team Leader position is a permanent position and comes with a competitive basic salary. 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.

  • Competitive
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    A global medical device company are recruiting for a HR Business Partner based in North West of London. This is an opportunity to join a reputable Medical Device company that are looking for a business partner who will be carrying out the following responsibilities:

    Responsibilities:

    • You will work across the full range of the HR function, and partner with managers and local HR to understand the key performance issues, objectives and drivers and in order to proactively drive the HR agenda.

    Requirements:

    • Demonstrated ability to consult, influence, and partner with senior leaders to drive business performance
    • Demonstrated relationship management skills at all levels of the organisation as well as team management
    • Experience in Organisational Design and creating High Performing Organisations.
    • Degree qualified or equivalent, ideally CIPD qualified.

    This is a 6-month contract role on a competitive day rate.

    Skills Alliance are the preferred supplier for this role. Please contact Gena Mazreku for more details on +44 207 220 6216 or click APPLY NOW.

  • Rate on application
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    A multinational medical manufacturing company are recruiting for a Service Now Consultant III based in North West London for a 6 month (100% remote) contract. This role is an excellent opportunity for a driven individual to work within a large, complex Transformation Programme, leading the delivery of one of the key technology solutions.

    The Service Now Consultant will be responsible for working with a number key stakeholders and third parties to successfully deliver the changes to Service Now Platform. In addition to managing and executing the project level plans to achieve the overarching Programme delivery. The Incumbent will play a key role in understanding the status, risks and issues at the project level and then reporting this into the overall Programme.

    Requirements:

    • Proven experience (5 years+) project managing SaaS and PaaS solutions, with specific knowledge in architecting solutions for ServiceNow
    • Significant experience in the delivery of design documentation addressing business requirements and translating those requirements to application development teams
    • Knowledge of ServiceNow/ITIL modules, particularly HR case management and the use of that technology in a similar large corporate organisation
    • Experience in designing and implementing complex, multi-tier, multi-tenant, end-to-end solutions in a high availability environment.
    • Proven success on projects with large-scale deployments; understanding of application life-cycle management.
    • Ability to work globally, with management of remote and distributed project teams

    This role is a 6 month contract on an excellent hourly rate. Skills Alliance are the preferred supplier for this role. Please contact Gena Mazreku for more details on +44 207 220 6216 or click APPLY NOW.

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    A leading global Pharmaceutical company are currently recruiting for a Safety Evaluation and Risk Management – Pharmacovigilance manager based in London. The role sits in the pharma safety group which supports all aspects of the safety profile of the company’s medicine portfolio both in development and post marketing.

    In this role you will join a team engaged in early post marketing activities for one of the recently launched respiratory medicines. The pace is very dynamic with some opportunity to work flexibly across different projects.

    Key Responsibilities:

    • Provide high level scientific expertise in the safety evaluation and risk management of GSK medicines either in clinical development and/or the post-marketing.
    • Ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives
    • Support the disease area or product area safety strategy at internal company cross functional meetings and may represent the company externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners
    • Participate in pharmacovigilance and risk management planning in the clinical matrix.
    • Plan and prioritize activities for designated products
    • Lead safety input into regulatory benefit-risk assessments and the preparation of Risk Management Plans
    • Deliver the clinical safety input into clinical development planning activities
    • May represent clinical safety on cross functional Clinical Matrix Teams and/or Project Teams.
    • Contribute to cross-functional ad hoc teams to address urgent and important product safety issues
    • Review and provide technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
    • May lead or participate in discussion at Global Safety Board for safety related findings.
    • Escalate safety signals appropriately as identified through the Safety Review Process

    Additional responsibilities in Signal Detection, Evaluation, Labelling and submissions

    • Requirements:
    • Prior experience in pharmacovigilance including aggregate reports and risk management activities.
    • Strong evaluation skills and analytical thinking
    • Medical writing skills
    • Sound knowledge of relevant pharmacovigilance regulations and methodologies applicable to safety evaluation and risk management activities
    • Track record of quality decision making, and problem resolution based on assessment of all relevant supporting and conflicting information/factors
    • Experience in managing complex tasks in a matrix team setting.
    • Degree in Biomedical or Health Care related specialty

    This role is based in London and comes with a competitive base salary + benefits package. Skills Alliance are the preferred supplier for this role. For more information or to apply please contact Ibraheem Idrissi on 0207 220 6204 or quick APPLY NOW!

  • Competitive
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    Skills Alliance has been exclusively retained by a clinical-stage, rare disease biotech to hire a Head of Clinical Operations to maintain exceptional clinical study standards for their growing pipeline. This highly visible position reports directly into the Chief Medical Officer and is office-based in Lombardy, Italy.

    The company has an active research pipeline of early and late-phase combinational therapies for a range of rare diseases with high unmet need. With patient enrollment nearing completion for their leading phase III asset, this position will support the delivery of their global study and ensure clinical filing by Q4 2020.

    This is an exciting opportunity for an experienced Clinical Operations professional to apply their technical and managerial expertise to advancing a pipeline of life-saving therapies.

    Responsibilities:

    • Provide strategic and operational direction to clinical development programs
    • Direct management of small clinical team; motivate and educate clinical staff
    • Ensure cross-collaboration with internal teams (CMC, Manufacturing, etc)
    • Identify, qualify and select sites, CROs and vendors (review of master service agreements, budgets and work/change orders)
    • Manage CROs and vendors; ensure trials are delivered on time and on budget
    • Hands-on approach to clinical activities (site/CRA performance reviews, manage data and clinical monitoring board, etc)
    • Manage electronic master file
    • Ensure studies in line with FDA, EMA, GCP, and ICH guidelines
    • Author and review study documents (clinical study protocols, informed consent forms, clinical study reports, etc)
    • Establish key partnerships with leading research institutes and maintain sponsor-site relationships
    • Participate in preparation of regulatory filings (IND, pre-IND, etc)


    Qualifications:

    • Fluent in English
    • Strong knowledge of FDA, EMA, GCP and ICH guidelines
    • Experience managing clinical study teams and external vendors (eg. CROs)
    • Track record of succesfully completing registration studies
    • Experience managing electronic master files
    • NDA filing experience
    • Strong leadership and communication skills

    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 exclusively partnered with a mid-sized Biopharmaceutical company looking to hire a Director, Medical Affairs to provide strategical support for their growing Neuroscience franchise. The role reports into the Executive Director, Medical Affairs, Neuroscience and is office-based in the Greater San Francisco Bay area.

    This is a dynamic, highly collaborative and science-focused organisation with an established and expanding footprint in global markets, with several affiliate offices. The position is strategic with accountability for fostering internal collaborations with R&D, Commercial and other departments, and building strong relationships with external KOLs, ensuring all Medical Affairs material is current and meets all requirements. There is a strong preference for an experienced Medical Affairs leader with a strong understanding of neurology compounds and established network.

    Job Responsibilities:

    • Provide strategic input into internal Medical Affairs projects and additional guidance into other department-related activities (e.g. congresses preparation, planning, publications, medical information)
    • Give medical input into the integrated launch strategies, working closely with the Commercial, Clinical, and other internal teams
    • Contribute scientific knowledge into publication strategies (e.g. abstracts, posters)
    • Develop and actively participate in advisory boards
    • Provide medical and scientific input to responses to HCPs
    • Ensuring all Medical Affairs material is accurate and meaningful from clinical perspective
    • Assist with the medical affairs budget development and management

    Essential Qualifications

    • Advanced scientific degree
    • Industry experience in Medical Affairs leadership positions
    • Experience working on neurology assets
    • Strong scientific knowledge of neurology
    • Willingness to be office-based and ~20% travel


    Skills Alliance is exclusively partnered with this organization. All queries should be directed to Karina Sharipova who will be able to provide further information. Please call Karina on 020 7220 6205 or click APPLY to submit a copy of your CV.

  • £85 - £95 per hour
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    Skills Alliance are partnering with a very exciting mid-sized Biotech who are focussing on bringing a new drug through from the clinical trial to commercialisation across Europe. They need a strong Regulatory Affairs Director who is able to lead the MAA submission and has the experience of liaising with the relevant health bodies.

    This will be a 5 day a week freelance position for 12 months initially to be based in London (full time from home until Government guidelines change) with flex to work from home in the long term and an excellent rate on offer.

    Please let me know if this role is of your interest.

    Email: shakir.hossain (at) skillsalliance.com
    Phone: 0207 220 6232
    LinkedIn: Shakir Hossain

  • £300 - £350 per day
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    Skills Alliance are partnering with a very exciting Global Biopharmaceutical Company who are focusing on bringing a new drug through from the clinical trial to commercialisation across Europe.

    They need a strong Regulatory Affairs Associate who is able to support to the Intercontinental & Global Patient Solutions team with initial marketing applications, including responses to regulatory questions, launch activities, variations and renewals.

    This will be a 5 day a week freelance position for 12 months to be based in Cambridge and an excellent rate on offer.

    Please let me know if this role is of your interest?

    Email: shakir.hossain(at)skillsalliance.com
    Phone: 0207 220 6232

  • £50 - £60 per hour
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    Skills Alliance are partnering with a very exciting Global Biotech Company who specialise in rare diseases. They need a strong Medical Writer who is able to support with drafting and editing documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)

    This will be a 5 day a week freelance position for 12 months initially to be based in London (remote working available due to government travel restrictions) and an excellent rate on offer.

    Please let me know if this role is of your interest?

    Email: shakir.hossain (at) skillsalliance.com
    Phone: 0207 220 6232

  • £50 - £60 per hour
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    Skills Alliance are partnering with a very exciting Global Biotech Company who specialise in antiviral drugs. They need a strong Medical Writer who is able to support with drafting and editing regulatory documents (CSRs, PIPs, etc.)

    This will be a 5 day a week freelance position for 12 months initially to be based in London (remote working available) and an excellent rate on offer.

    Please let me know if this role is of your interest.

    Email: shakir.hossain (at) skillsalliance.com
    Phone: 0207 220 6232

  • £60000 - £80000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (near Euston) with some flexibility. The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

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    Skills Alliance has been exclusively retained by a clinical-stage biotechnology company to hire an International Medical Science Liaison as part of their global team build in Medical Affairs.
    The company has an innovative and active research pipeline focused on enzyme therapies in pre-clinical and clinical stage for rare and oncologic diseases. Following successful Phase II data on the lead asset, a global Phase III trial is now underway.

    To support the VP Global Medical Affairs, the company is hiring an International MSL to cover Italy, Germany and further countries. This is a rare opportunity for a scientifically driven, patient-centric individual to help devise and shape the medical strategy and bring an orphan drug to market in 2020/2021.

    Job Responsibilities:

    • Create and implement strategic Medical Affairs plans in line with the biotech’s product development objectives
    • Build an extensive regional KOL network to ensure successful implementation of the medical strategy
    • Implement local pharmaceutical regulations and company policies and procedures
    • Be a reliable and trusted source for accurate medical and scientific knowledge, providing product information and the disease state as requested in an accurate and timely manner
    • Feed back field insights to internal stakeholders and coordinate with internal teams
    • Collaborate with Clinical and Regulatory teams in identifying sites, recruitment, evaluation and training to advance clinical trial execution at study sites
    • Implement medical affairs practices to assess potential new indications, including the treating community, patient pathways, diagnostic practices and management
    • Identify potential high-impact medical research projects and publication opportunities, in line with the company’s’ identified areas of interest
    • Conduct training with CRO, CRAs and study site staff as required
    • Support cross-functional collaboration to ensure operations are patient-focused



    Qualifications:

    • Advanced scientific degree (PhD, PharmD, MD)
    • Fluent in Italian and English, Fluency in German is a benefit
    • Prior industry experience in a similar MSL role
    • Experience with Hematological or rare diseases is essential
    • Willingness for up to 70% travel time
    • Excellent rapport building and interpersonal skills

    The role will involve paving the way for pioneering science with great autonomy and accountability for the medical strategy, with a direct reporting line and exposure to senior management. Skills Alliance is exclusively partnered with this innovative biotech.

    Please click APPLY or call 0044 203 772 8232 to receive further information, including a full job description.

  • Competitive Pay + Benefits
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    We are partnered with a clinical stage biopharma in New York who are passionate about focusing on developing therapies for the treatment of cancer patients with unmet needs with the goal of improving patients’ outcomes. They have an incredibly strong pipeline, including over 10 products in various stages, preclinical through Phase III.

    They are looking for a Director of Clinical Operations to play a key leadership role in moving their clinical studies forward. They are searching for someone with a prior pharma background who has specifically worked within oncology. Prior hematology and radio-immunotherapy drug experience a plus! A leader and someone to be hands on with strong communication and presentation skills who is passionate about their mission to improve patient lives.

    • Bachelor’s degree required, advanced degree preferred
    • Minimum of 3-5+ years of experience in clinical research required, with at least 2 years’ oncology experience
    • Previous experience monitoring at clinical sites preferred
    • Training in GCP and knowledge of the research process, of the importance of adherence to protocols, and of the accuracy needed in collection and documentation of research data

    This job is moving quickly, so do not hesitate to apply!

  • Regulatory Affairs Director

    This is an exciting opportunity for someone with extensive Regulatory Affairs background to join a pioneering Biotech company to hire a Director, Regulatory Affairs for a 12-month fixed term contract to join their organisation.

    With a very strong pipeline, their current focus is to move from Phase III to commercialisation, with the intention to supply globally. This position will facilitate interfacing between internal and external stakeholders of the organisation and being the main point of contact with all regulatory bodies to assist the process of approving the product to market. The Regulatory Affairs Director will also create and implement different regulatory strategies and will effectively communicate and manage other partnering organisations as appropriate, while assisting with all Regulatory matters.

    Responsibilities:

    • Coordinate and prepare meetings with regulatory agencies
    • Oversee the regulatory collaboration with CROs
    • Drive collaboration with the Legal and Compliance Team
    • Write and amend electronic submissions to facilitate regulatory agency requests

    Requirements:

    • Bachelor’s degree in Life Science/ advanced degree preferred
    • Strong verbal and written communication skills
    • Strong strategic-thinking and organisational skills
    • Prior experience working on an EU regulatory procedure

    This is a 12-month fixed term contract position based in London with full-time working from home until current national restrictions change, and a great salary on offer.

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

  • Quality Specialist


    This is a great opportunity to join a successful and rapidly growing pharmaceutical company, currently recruiting for a Quality Specialist.

    If you are looking for a more challenging role within a well-funded pharma company that will give you the opportunity to progress, this is it! As the company expands, you will have the capability to progress within your career, as well as contributing towards making a difference within the healthcare industry.

    Responsibilities:

    • To support Quality Operations in the warehouse

    • To review pharmaceutical product batch files

    • To provide QA support

    • To monitor Complaints, CAPA, Deviation and Change Control

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Previous experience working in a GMP environment

    • Enthusiastic and highly motivated

    • Excellent communicator

    This is an office-based position in Essex. It is a temporary 12-month contract role offering a competitive salary which can be discussed on the application.

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

  • Procurement

    £400 - £425 per day
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    Skills Alliance are working with a global pharmaceutical organisation on a major transformation programme surrounding a number of internal systems. These include implementation and upgrades for SAP P2P, O2C, FIN, EDM, BPC systems, amongst others. They require a strong communicator with a proven background in SAP change programmes to join and be the ambassador to act on behalf of the project delivery team to the rest of the affiliate departments within the organisation. This will be a 12 month contract, based in Surrey, however will offer flexible working.

    Job Purpose:
    The Transition Lead supports the EMEA programme in developing regionally standardised processes and improving the performance of the organisation to meet the process and system related programme objectives.

    Specifically, they will be responsible for ensuring that market unique requirements are recognised and implemented in the global template design. This will occur through:

    • Participation in the development and implementation of standard processes and Master Data
    • Participation in planning and execution of the process change management activities
    • Effective definition and communication of process controls in EMEA in order to support a culture of compliance

    The role will cover multiple Affiliates in a heavily matrixed environment and will be responsible for leading change and process enhancements in their respective markets. In order to ensure a successful outcome for their relevant markets, influencing will be required of a significant network of key stakeholders.


    Key Responsibilities:

    • Participate in development of standard processes and Master Data as part of the programme
    • Participate in implementation of standard processes and Master Data as part of the programme
    • Participate in planning and execution of the programme related process change management activities
    • Assist in defining and communicating controls in EMEA, support a culture of compliance

    Required Experience:

    • Strong experience working with SAP across systems/modules covering P2P, O2C, FIN, EDM, BPC functions, amongst others.
    • Experience acting as a transition/change manager or team lead, within SAP implementation or upgrade projects.
    • Experience working cross-functionally, managing key stakeholders from areas such as affiliates, manufacturing, finance and general business services, to name a few.
    • Proven delivery track record in complex, multi-national environments.
  • Scientific

    Competitive Salary + Benefits
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    I’m working a confidential search with a pioneering biotechnology company working to expand the human healthspan by slowing and reversing age related diseases. Working at the forefront of biotechnology and medicine, their main mission stands behind extending our health unburdened by the disease of aging.

    In this role would, you would play a crucial part in experimental design and execution, analysis and interpretation of data, and presentation of findings to the larger Discovery organization. You would have a truly important role in the critical selection of clinical development candidates.

    Requirements:

    • Bachelor’s degree with >4 years of scientific experience or a Master’s degree and >2 years of experience
    • Experience in at least one of the following areas: multi-color flow cytometry, cellular immunology including primary cell isolation, cell transfections/transductions using retroviral or lentiviral systems, CRISPR/gene editing, antibody discovery and characterization
    • Experience in developing & utilizing cellular assays: cytotoxicity, proliferation and differentiation endpoints
    • Expertise in culture of primary cells and immortalized cell lines
    • Experience working with and characterizing/validating antibodies is highly preferred

    We are moving very quickly with this role, so please don’t hesitate to apply!

  • Clinical Operations

    £65000 - £80000 per annum, Bonus + benefits
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    Great opportunity for a Senior Study Manager to join a niche Bitoech working in advanced therapies. This is a very varied role, it is permanent, full-time and office-based in West London.

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need a senior and autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and ATMPs.

    This is a permanent and full-time role. They would prefer people to be office-based in London. They offer an excellent salary – up to £80K + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £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 55-70K 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.

  • Pharmacovigilance

    €700 - €1000 per day
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    Skills Alliance are exclusively working with a Biotech to support their PV requirements.

    Role: EU D/QPPV Physician or Non Physician

    A leading biotech in Rare Disease and Liver Disease with an active clinical pipeline and marketd products. This is a fast paced, accountable and autonomous envoirnment with a driven and energic team.

    The role will require hands on knowldge of Rep of Ire PV local regulations and EU and QPPV or Director level experince.

    Role:

    • Establish and maintain PV system to ensure compliance with all legal and regulatory requirements in the EU for the applicable Marketing Authorisations
    • Act as the main point of contact with EU competent authorities for Pharmacovigilance
    • Must have strong EMA, EU national Competent Authority PV inspection experience
    • If not a physician, a registered Pharmacist or science graduate
    • Flexible working, 2-4 days a week, remote
  • Quality

    £30000 - £40000 per annum
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    QC First Line Manager

    This is a great opportunity to join a growing and very exciting bio-pharmaceutical company, currently recruiting for a Senior QC Line Manager.

    You would be part of a well-established Pharma organisation and will get the chance to gain managerial experience whilst supervising more junior QC members. Also, this opportunity will allow you to improve your QC skillset even further as you will have to support the QC function and provide specialist training in microbiological environmental monitoring methods.

    Responsibilities:

    • Manage the performance of the Environmental Monitoring Team
    • Write and update SOPs
    • Execute CAPAs and compliance action items in a timely manner
    • Support QC staff with training as necessary

    Requirements:

    • Minimum 3 years of experience working in a laboratory
    • QC, HPLC, GMP, GLP knowledge
    • Bachelor’s Degree
    • Excellent interpersonal and communication skills

    This QC First Line Manager position is a permanent position based in South West of England and comes with a competitive basic salary. 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.