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    Skills Alliance is partnered with a global pharmaceutical company that is currently looking for a Product Manager – Immunology to join their Immunology & HAE Sales and Marketing team in the area around Amsterdam.

    Employment Type: Full-time, Permanent
    Location: Amsterdam, Netherlands
    Language Requirements: Dutch and English

    Essential Duties & Responsibilities:

    • Lead the cross-functional team through strategic planning process, from analysis to strategy development and to implementation.
    • Identify and Implement multi-channel engagement strategies and solutions including digital, mailings & newsletter, media & PR activities for all customers in line with the strategic plan and compliance.
    • Manage marketing campaigns across print, promotional materials, congresses and online platforms; ensure high standard to meet customers’ expectations and to build the credibility of brand.
    • Collect and analyse data and insights on market dynamics, customer trends, brand positioning and competitors’ activities. Establish and assess KPIs for brand awareness, adoption and advocacy.
    • Lead and manage end to end new indications’ launches and other brand life cycle events.
    • Support the forecasting & planning process by providing insights on the market trends and growth opportunities.

    Skills and Competencies:

    • Strategic Approach: Balances between the long-term vision while driving the short-term goals.
    • Analytical thinking: Ensures that all marketing activities are based on solid insights and are being constantly optimized through well-defined KPIs.
    • Project management: Masters agility and effectively juggles between tasks leading the brand team through complex projects.
    • Collaboration: Builds a collaborative network of relationships with people in a variety of functions and roles and leverages formal and informal networks to accomplish goals.
    • Drive for Results: Holds self and others accountable for delivering on commitments that align with the company’s short- and long-term goals.
    • Engage Others- Communicate with Impact: Motivates and influences others to gain support for ideas, strategies and actions in service to providing superior pharmaceutical products to patients.
    • Customer & Patient centricity: Focuses on customer experience and satisfaction and delivers a quality service or product to the agreed standards.
    • Experience with new innovative technologies like Augmented reality.
    • Outstanding communication skills and ability to influence without authority.

    Education and Experience:

    • Degree in Marketing, Commercial Economics, Communication, and/or Life Sciences
    • Minimum 6-8 years of experience as a Product Manager in the pharmaceutical industry
    • Marketing experience within Immunology and/or Medical Device would be highly desirable
    • Experience in product life cycle management (launches, LOE management etc.)
    • Proven track record of managing complex cross functional projects in matrix organization
    • Excellent understanding of marketing and sales, including new marketing techniques
    • Proven knowledge of commercial processes/business acumen, standards, procedures, policies and codes of conduct of pharmaceutical market

    If you believe that you have the required background and skills for this position or if you would like to discuss this vacancy in detail, please feel free to contact Egi Bendo at +41 43 508 21 04.

  • UK

    Competitive salary + bonus + extensive benefits
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    My client is a leading global CRO that are looking for a CRA II or Senior CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials outsourced to one of the worlds largest and best-known pharmaceutical companies who offer excellent routes for progression.

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

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

    Key points:

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

    Key Requirements:

    • Effective clinical monitoring skills
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Flexibility and adaptability
    • Proficiency in Microsoft package

    Skills Alliance are the exclusive and preferred suppliers for this role. Please contact Arturo Maldonado for more information on 0203 668 3963
    Alternatively, click APPLY NOW

  • UK

    Competitive salary + bonus + extensive benefits
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    My client is a global pharmaceutical company who are looking for a Senior CRA by title to join their clinical operations team focused in the Oncology division.
    The title of the role is Senior CRA, however, the responsibilities are that of a study manager. There are no or very little monitoring aspects involved.
    This is an excellent opportunity to join a leading organisation in the industry with an exciting pipeline. There are also excellent opportunities for growth and development in a dynamic team.
    This is a permanent, full-time, office-based role just north of London.

    Key responsibilities:

    • Assist Clinical Lead with the management of one or more Oncology studies
    • Ensuring study milestones and deliverables are achieved
    • Ensuring the quality of data for submission
    • Oversight of CRO and vendors
    • Ensuring studies are executed to ICH-GCP and company SOPs

    Key Requirements:

    • Lead CRA experience managing one or more trials in EMEA
    • Therapeutic experience in Oncology and early phase trials
    • International monitoring or team leader experience
    • Life science degree
    • Excellent knowledge of ICH-GCP guidelines

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

  • UK

    Competitive salary including bonus and benefits
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    My client is a global pharmaceutical company who are looking for a Director to join their clinical operations team focused in the Oncology division.
    This is an excellent opportunity to join a leading organisation in the industry with an exciting pipeline. There are also excellent opportunities for growth and development in a dynamic team.
    This is a permanent, full-time, office-based role just north of London.

    Key responsibilities:

    • Provide oversight of a portfolio of a range of early phase clinical trials in Oncology
    • Line and matrix management of multiple global study managers across the world
    • Ensuring study managers are meeting development milestones and supporting them in this
    • Budget and resource allocation

    Key Requirements:

    • Significant experience working in Oncology and early phase studies
    • Strong line management experience of study managers across the EMEA region
    • Life science degree
    • Excellent knowledge of GCP guidelines and SOPs

    Skills Alliance are the preferred suppliers for this role. Please contact Arturo Maldonado on 02036683963 to discuss further, or alternatively apply now.

  • UK

    £50000 - £55000 per annum, Bonus + extensive benefits package
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    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 and 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.

  • Competitive salary + benefits
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    An exciting medium size, privately owned CRO is looking for a CRA II or Senior CRA for their operations in Germany.
    It is a great opportunity for an experienced Clinical Research Associate or a CRA II/Senior CRA to undertake more responsibilities and work on challenging studies, in complex therapeutic areas in a company that offers great career progression opportunities as they expand their European Operations as well as close collaboration with management.

    You would be responsible for overseeing the monitoring and start-up activities for their German operations.

    This (Senior) Clinical Research Associate/CRA II role is a homebased role in Germany. It is a permanent role and there is a competitive salary and package.

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

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    Medical Information Specialist, EU – ENTRY LEVEL ROLE for Pharmacists

    I am currently working with a client of mine who are renonwed for their work within the neurology and psychiatry space. My client are currently going through a huge period of growth and restructure, and through internal promotions they now have a vacant position in their medical information team.

    This is an exciting opportunity for any qualified pharmacists who are looking to move into the pharmaceutical industry. If you’re considering a career in medical affairs with your pharmacy degree, this is a great chance to take on the experience you need to move into the medical affairs arena.

    This position comes with great autonomy and means you will have to be fairly independent in taking on this position, but full training will be provided on the company’s systems and processes within medical information.

    The more experience you gain in this role, the more you will get the chance to work cross-functionally with commercial teams but you will also be expected to work closely with the wider medical affairs team as well as the MSLs.

    This is a company who encourage promoting within and opportunities like this don’t come around often, so get in touch now to ensure you don’t miss out!

    Ths position is based in central London and is office-based.

    For more information, please contact Chanel Hicken on 0207 220 6206 or email me your CV and we can arrange a time for a confidential discussion on how this could be the perfect role for you.

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    Our client is very innovative and dynamic biopharmaceutical company based in Basel area. They are looking for an experienced scientist/physician to join their team in a position of

    Senior Drug Safety Physician

    Responsibilities

    • Accountable for all aspects of safety related to the assigned projects/products including medical assessment, aggregate reporting, signal detection, risk management, and risk minimization activities throughout the product’s life cycle
    • Leads the cross-functional Safety Management Team (SMT) for assigned projects/products; responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical throughout life cycle product management
    • Coordinates and ensures good quality presentation by the SMT at Client Drug Safety Committee
    • Provide drug safety expertise in all phases of drug development
    • Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information
    • Responsible for the preparation of aggregated periodic safety reports: DSUR, PSUR/PBRER, Reference Safety Information (RSI) section of the Investigator Brochure (IB) and contribute to other key regulatory key safety documents
    • Review, contribute and provide medical and safety expertise for study synopsis, protocol, Core Informed Consent (CIC), Briefing Book (BB), Clinical Development Plan (CDP), Clinical Study Report (CSR), Investigational Medicinal Product Dossier (IMPD), Statistical Analysis Plan (SAP) and Pediatric Investigation Plan (PIP) as required
    • Represents Client in interactions with Health Authorities and Independent Data Safety Monitoring
    • Responsible for responses on safety inquiries from regulatory authorities or health care professionals

    Requirements

    • Doctor of Medicine degree with at least 7-year experience in clinical and post-marketing safety and/or clinical development in the pharmaceutical or biotechnology industry
    • Broad scientific background and excellent clinical development knowledge, experience and ability to interpret clinical study safety information
    • Possessing extensive medicinal product and disease knowledge based on didactic and clinical experience, with considerable additional expertise in safety surveillance and pharmacovigilance
    • Full understanding of the clinical trials and post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of investigational and post-marketing regulatory safety reports/documents
    • Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements
    • Previous experience with regulatory filing and contribution to key safety documents
    • Good experience and knowledge with safety signal identification methodology and risk minimization measures
    • Excellent medical writing, presentation and communication skills
  • UK

    £45000 - £55000 per annum
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    Clinical Quality Assurance Manager


    A rare opportunity to join a global, mid-sized leading pharmaceutical company, currently recruiting for a Clinical Quality Assurance Manager.

    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 the development of product portfolios for both business groups.

    Responsibilities:

    • To support audit programs in EMEA region

    • To report and plan GCP Investigator site audits in EMEA region

    • To conduct GCP vendor and GCP System and process audits

    • To maintain CQA Management Program

    Requirements:

    • Excellent auditing and quality knowledge

    • Good knowledge of phase II and III studies

    • Management experience

    • Excellent communicator

    This is an office-based position based in North London. It is a permanent role offering a competitive salary between 45K-55K and the chance to travel in the EMEA region up to 30% of the time.

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

  • UK

    £18000 - £23000 per annum
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    Quality Officer

    Are you a graduate and looking to take the first step in your career within the pharmaceutical industry?

    My client is a well-established organisation focusing on offering a range of medical products, currently recruiting for a Quality Officer to join their growing team.

    This is a perfect opportunity to join a well-known Pharma organisation, with a strong culture and great career progression opportunities. As the company expands, you will have the chance to contribute towards reaching the companies vision and enlarge your knowledge within the wider business by providing administrative support and taking on a range of other responsibilities.

    Responsibilities:

    • To support the activities related to the launch of a product

    • To maintain GMP/GDP guidelines

    • To coordinate and review internal and external audits

    • To support SOPs and associated documents

    Requirements:

    • A Science degree

    • Good written and spoken English

    • Ability to maintain a professional behaviour

    • Excellent communication skills

    This is an office-based position based in Hampshire. It is a permanent role offering a competitive salary up to 23K, 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.

  • UK

    £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.

  • £55000 - £65000 per annum, car allowance + bonus
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    Medical Science Liaison – Young Biotech Company working in Medicinal Cannabis

    Skills Alliance have partnered with a brand new biotechnology company in the field of medicinal cannabis who are eager to expand their team by recruiting an experienced MSL to get involved in this exciting area of life sciences.

    This is a great chance to join a young biotech who are looking for inspiring talent within the market to further enhance and expand their current skillset as an MSL.

    The use of medicinal cannabis in the UK is becoming more and more common among specialist clinicians as treatment for epilepsy, multiple sclerosis and even chronic pain, with the science behind the use of medicinal cannabis offering huge potential for the life sciences industry.

    If you have experience as an MSL and are considering moving into a new area of science, this is a great opportunity to take on that challenge. Our client is looking for someone who has MSL experience ideally in the field of neurology, palliative care or, of course, within the medicinal cannabis space.

    As an MSL, you will be responsible for targeting mostly specialist clinicians and professors within the field of medicinal cannabis to effectively communicate medical and scientific information about the uses, strains and doses of medicinal cannabis therefore being able to provide the gold standard of medical education to the specialist clinicians and other healthcare professionals and key opinion leaders.

    For more information about this position or any similar positions I may have available, please contact Chanel Hicken on 0207 220 6206.

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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 antibody 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 MSL to cover the United Kingdom. The role will be remote-based and will involve some international travel to mainland Europe. This is a rare opportunity for a scientifically driven, patient-centric individual to help devise and shape the medical strategy and bring an ultra-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)
    • Prior industry experience in a similar MSL role
    • Neurology/hematology experience preferred (specialty / rare / orphan / metabolic disease also an advantage)
    • Willingness for up to 50% travel time
    • Excellent rapport building and interpersonal skills
    • Strong command of the English language

    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 Karina Sharipova at +44 (0) 207 220 6205 to receive further information, including a full job description.

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    Skills Alliance has been exclusively retained by a global biopharmaceutical company to hire a VP, Medical Affairs, International to lead the expanding ex-US Medical Affairs organisation. The individual can be based remotely in Switzerland, France, Germany or the Netherlands with a commuter agreement to London.

    As the business prepares for a potential blockbuster launch in 2020, this individual will lead a team of 50 and serve as a member of the Medical Affairs and International leadership teams. The company has an impressive pipeline in an area of unmet medical need with one globally approved and marketed first-in-class product. They are well-funded, with a strong cash position and significant R&D spend, and expect to be first- and best-in-class for their upcoming drug launch.

    Reporting to the SVP Global Medical Affairs, this position will lead the ex-US team, with a focus on developing the medical strategy for Europe and Canada. This is a great opportunity for a senior Medical Affairs professional to grow and transform the function and to bring a potential blockbuster drug to market.

    Responsibilities

    • Manage the International Medical Affairs team, driving the ex-US strategy and developing the team
    • Foster cross-functional collaboration between the medical, commercial and scientific functions for broader input into development programs and the medical affairs strategy
    • Develop international medical strategy through partnerships with the Medical Affairs Leadership and International teams
    • Make sure the Medical Affairs team is well informed on the company’s therapeutics areas, medicines and pipeline products (e.g. understanding of study design, interpreting data, global medical treatment programs, pharmacology)
    • Lead medical and scientific interactions with medical societies and external experts, supporting advocacy development and education
    • Provide medical expertise and support to internal groups (e.g. medical information, commercial) and external stakeholders (e.g. payers, subject matter experts)
    • Manage resource planning for medical affairs, including budgets, setting timelines and identifying potential issues and creating contingency plans for them
    • Provide medical input into clinical development and research, along with business development and lifecycle activities


    Qualifications:

    • Advanced degree (MD, PhD)
    • Several years of leadership experience in a biotechnology or pharmaceutical company
    • Deep knowledge of the Medical Affairs function, leading international teams (experience in Europe and Canada preferred)
    • Drug launch experience
    • Knowledge or European and Canadian regulatory agencies (e.g. access, specific processes)
    • Willingness for up to 50% travel
    • Experience in endocrinology, gastro or hepatology preferred
    • Experience in safety audits and additional safety activities from a Medical perspective preferred


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

  • UK

    £40000 - £50000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager or Junior Clinical Study Manager role based in London and working in cell and gene therapy.

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

    This is a full-time and permanent position. It is office-based in London with flexibility to work from home for the right candidate. They offer an excellent salary and package around GBP 40-50K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Junior Clinical Study Manager / Junior Clinical Trial 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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    Clinical Study Manager opportunity with a World-class Pharma company, working specifically in Oncology studies. The role is based just North of London and is permanent and full-time.

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

    This is a full-time and permanent position. It is office-based just North of London with flexibility. They offer an excellent salary and package around GBP 55-65K 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.

  • UK

    £55000 - £65000 per annum, excellent package
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    Clinical Trial Manager opportunity with a World-class Pharma company, working specifically in Oncology studies. The role is based just North of London and is permanent and full-time.

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

    This is a full-time and permanent position. It is office-based just North of London with flexibility. They offer an excellent salary and package around GBP 55-65K 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 - £60000 per annum, Bonus + benefits
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    Great opportunity for a Project Manager or Senior Project Manager to join a niche and growing organisation. This is a very varied role, it is permanent, full-time and home-based anywhere in the UK going to the office every few weeks.

    The role is with a niche company who are leaders in the market. The company have seen rapid growth in the past 5 years and will continue to grow and evolve, as such they need someone who is adaptable.

    The position is a wide ranging one with responsibility for project work, oversight of clinical teams, client facing responsibility and potentially line management if you are interested in that area. They require previous clinical project management experience and international experience.

    This is a permanent and full-time role (may be flex on this). They can consider strong candidates to be home-based across the UK. They offer an excellent salary + 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.

    Keywords: Clinical Study Manager / Junior Study Manager / Senior Study Manager / Clinical Trial Manager / Senior Project Manager / Clinical Project Manager / Oncology / London / Berkshire / Pharma / Biotech / UK / London / Hertfordshire / Herts / Niche / CRO

  • UK

    Excellent salary and package - £100K +
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    This is a rare opportunity to join a fast-growing UK based Biotech company working in a very niche an innovative area. They work in complex early phase trials and are growing rapidly. The company has a strong leadership team and is very well financed. They expect to double in size in the next few years, therefore offering good progression opportunities.

    The Director of Clinical Operations position is a pivotal role within the company and will have high visibility reporting to board level. They require someone to come in and oversee the clinical function. Whilst running international trials, the company and role is UK based.

    This will involve oversight of the clinical department and multiple early-phase programs in complex therapy areas as well as line management of the clin ops team. They need an experienced Director level candidate. Given their technology, they plan to expand into other therapy areas quite quickly.

    Being a small Biotech, there is a preference for someone who has worked in a similar environment previously or someone who can demonstrate the ability to take on a lot of responsibility outside of the job spec. They will need to work with a high level of autonomy and make strategic decisions.

    This is a full-time and permanent position, office-based in the South East but with a good level of flexibility. The salary will be in line with a position at this level – £100K + and with a good benefits package + bonus + stock.

    Please contact Mark Anderson for more details – call 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

    £60000 - £70000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Senior Clinical Study Manager role based in West London and working in one of their leading therapy areas.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for one of their leading TAs, a life threatening area, therefore the opportunity to have a real impact on patients. They will be expanding and will offer great long-term prospects. The company are looking for an experienced PM or Study Manager, ideally with line management experience. This would be working on studies at the cutting edge of science.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work. They offer an excellent salary and package around GBP 60-70K depending on experience + bonus + extensive benefits + stock options.

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

  • €50000 - €60000 per annum
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    Skills Alliance is exclusively collaborating with Takeda to recruit a Quality Validation Engineer to join Takeda’s manufacturing facility in Lessines.

    Responsibilities:

    • Review/approval of validation documentation, specification documents (URS, Functional/ Design Specification) and study protocols/ reports (IQ/ OQ/ PQ/ PPQ) to ensure compliance to procedures and regulatory requirements.
    • Review and approve test incident occurred during the validation in a quality perspective
    • Participate and approve the risk analysis linked to validation activities in a quality perspective.
    • Review/approval of periodic review of critical system to ensure compliance to procedures and regulatory requirements.
    • Collaboration and participations in projects as Quality Representative for Validation. Provide quality guidance for the development of the validation approach. Assure requirements traceability throughout the whole project validation file (from URS to PQ).
    • Take part in internal and external audits.

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

  • UK

    £45000 - £55000 per annum
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    Clinical Quality Assurance Manager


    A rare opportunity to join a global, mid-sized leading pharmaceutical company, currently recruiting for a Clinical Quality Assurance Manager.

    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 the development of product portfolios for both business groups.

    Responsibilities:

    • To support audit programs in EMEA region

    • To report and plan GCP Investigator site audits in EMEA region

    • To conduct GCP vendor and GCP System and process audits

    • To maintain CQA Management Program

    Requirements:

    • Excellent auditing and quality knowledge

    • Good knowledge of phase II and III studies

    • Management experience

    • Excellent communicator

    This is an office-based position based in North London. It is a permanent role offering a competitive salary between 45K-55K and the chance to travel in the EMEA region up to 30% of the time.

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

  • UK

    £45000 - £50000 per annum
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    Skills Alliance are partnering a growing global pharmaceutical organisation based in London. They are seeking an experienced supply chain manager with a strong background in life sciences or FMCG, to support the set-up and development of the entire supply chain function. This presents an excellent opportunity for a driven, proactive supply chain professional that is keen to be a part of a comprehensive supply chain expansion programme.


    The Role:

    As part of this role you will be leading the set-up and development of the supply chain function. This will include improving our current supply chain, expanding the supply chain into new markets and developing a long-term supply chain strategy. Over the medium to long term, it is expected that you would build your own supply chain team. The supply chain function encompasses both medical device and pharmaceutical needs to conform with a range of regulatory requirements both locally and internationally. Responsibilities for this role will include the following:

    • Planning and implementing the overall supply chain strategy
    • Providing purchase orders and managing logistics to facilitate collection and delivery of products
    • Managing all operations both inbound and outbound for finished products and materials and being the key point of contact for suppliers, CMO’s and distributors
    • Ensuring all necessary import and export permits are in place to allow goods to move
    • Collaborating with individuals across the business, both employees and external advisors, to manage and execute the day to day operations
    • Creating and owning product demand forecasts and inventories, keeping an accurate record of the process and analysing performance, providing opportunities to reduce costs
    • Develop and implement processes (S&OP) and KPI scorecard to measure the performance of the supply chain
    • Working with Finance, Sales, and Manufacturing teams to determine best vendors and distributors in an effort to improve financial and operational performance
    • Build and maintain good relationships with vendors
    • Improving the overall supply chain performance and look for any possible innovations to the process


    Required Attributes:

    • Extremely organised with strong planning skills and a good eye for detail
    • Critical thinker and problem-solving skills with a logical and systematic approach to work
    • Have a ‘can-do’ attitude and no task is too big or too small for you
    • Able to work in a fast paced and dynamic environment, both autonomously or part of a team
    • Highly PC literate with strong competence in Microsoft Word and Excel and familiarity with software relevant to accounting and auditing software and/or supply chain management
    • Sense of ownership and pride in your performance and its impact on company success
    • Desire to build and develop supply chain capability within the organisation
    • The ideal candidate will have a desire to take on more responsibility and expand the capabilities of the organisation. They will have developed their skill set in fast paced industries where compliance with regulation is important and be eager to apply those skills and learnings to new applications and environments. There is a significant strategic element to this role, developing the supply chain strategy and ensuring it meets the needs of the growing business.
    • The candidate must be comfortable in a start-up environment and thrive with high levels of change. We are looking for people who want to learn new skills and know-how as we develop.


    Required Experience:

    • Bachelor’s degree or higher in a relevant area (business, finance, engineering, logistics, supply chain, procurement, etc.)
    • 7-10 years + demonstrable experience in domestic and international supply chain operations ideally in consumer healthcare or FMCG
    • Experience operating within different regulated environments, and aware of regulatory affairs requirements in supply chain
    • Experience launching products to international markets, from early planning through to execution and hitting commercial milestones
    • Experience developing and implementation of supply chain strategy in conjunction with all areas of the business, this should include forecasting and commercial skills and team building across multiple markets
    • An understanding of supply-side financial and operational metrics, it is desirable for this experience to have been gained in the pharmaceutical and/or medical device industry however we recognise this is a transferrable skill set and are open to candidates with backgrounds from other industries such as FMCG
    • Desirable: Medical devices background and a passion for healthcare
  • 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 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.
  • 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.
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    Our client is very innovative and dynamic biopharmaceutical company based in Basel area. They are looking for a physician with extensive experience in in clinical and post-marekting safety to join their team in a position of

    Senior Drug Safety Physician

    Responsibilities

    • Accountable for all aspects of safety related to the assigned projects/products including medical assessment, aggregate reporting, signal detection, risk management, and risk minimization activities throughout the product’s life cycle
    • Leads the cross-functional Safety Management Team (SMT) for assigned projects/products; responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical throughout life cycle product management
    • Coordinates and ensures good quality presentation by the SMT at Client Drug Safety Committee
    • Provide drug safety expertise in all phases of drug development
    • Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information
    • Responsible for the preparation of aggregated periodic safety reports: DSUR, PSUR/PBRER, Reference Safety Information (RSI) section of the Investigator Brochure (IB) and contribute to other key regulatory key safety documents
    • Review, contribute and provide medical and safety expertise for study synopsis, protocol, Core Informed Consent (CIC), Briefing Book (BB), Clinical Development Plan (CDP), Clinical Study Report (CSR), Investigational Medicinal Product Dossier (IMPD), Statistical Analysis Plan (SAP) and Pediatric Investigation Plan (PIP) as required
    • Represents Client in interactions with Health Authorities and Independent Data Safety Monitoring
    • Responsible for responses on safety inquiries from regulatory authorities or health care professionals

    Requirements

    • Doctor of Medicine degree with at least 7-year experience in clinical and post-marketing safety and/or clinical development in the pharmaceutical or biotechnology industry
    • Broad scientific background and excellent clinical development knowledge, experience and ability to interpret clinical study safety information
    • Possessing extensive medicinal product and disease knowledge based on didactic and clinical experience, with considerable additional expertise in safety surveillance and pharmacovigilance
    • Full understanding of the clinical trials and post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of investigational and post-marketing regulatory safety reports/documents
    • Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements
    • Previous experience with regulatory filing and contribution to key safety documents
    • Good experience and knowledge with safety signal identification methodology and risk minimization measures
    • Excellent medical writing, presentation and communication skills

    For more information please contact Maja Vidovic:

    M: 0041 22 518 82 49

  • £55000 - £62000 per annum
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    A Leading global Biopharmaceutical company are recruiting for a Regulatory Affairs Manager position based in the Benelux region.

    This is an opportunity to be a part a growing International Regulatory Affairs team that are paving a new way to develop medications to deliver to patients across the globe. The rapid growth of the company is accompanied by excellent career progression opportunities.

    Responsibilities:

    • Review the draft guideline for EU and provide the comments on the draft guidance for EU environment shaping
    • Sensing the EU regulatory change/trend and collect the regulatory intelligence and update the EU regulatory environment change
    • Develop EU specific SOPs and manuals in line with EU regulation/guidance and internal process
    • Provide regulatory strategies, risks and mitigations
    • Act as a local representative for clinical trial application in EU
    • CRO management on regulatory compliance submission (e.g. PSUR submission, pharmacovigilance)
    • Manage/support the regulatory procedure/document preparation including MAA, post-approval activities (e.g. EU document request, CPP request, legalisation, notarisation etc.)
    • Draft final labelling/artwork components for regulatory submissions/commercial purpose

    Requirements:

    • At least 4 years’ experience in relevant fields
    • Good breadth of understanding of the European regulations
    • Project management experience is preferred
    • A Bachelor’s degree in science or related fields

    This Regulatory Affair Manager position comes with a competitive salary of £55,000 – £62,000 and benefit package.

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

  • UK

    £50000 - £58000 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

    Now onto a little about the opportunity itself; You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline. The role requires a Regulatory associate with a background in Oncology and covering all aspects of CTA’s for their end client, clinical trial products.


    Responsibilities:

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



    Requirements:

    • Life-sciences graduate with at least 2 years of industry experience
    • Experience in a Regulatory enviroment with CT regulatory agency submissions in 2 or more countries
    • Detailed knowledge of ICH-GCP and local Regulatory agency and ethics committee regulations and requirements
    • Strong analytical and communication skills
    • Oncology experience
    • CRO experience

    This Senior Regulatory Affairs Associate role is an office-based position with flexibility in West Sussex. It is a permanent role offering an attractive salary between £50,000 – £58,000 + 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 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

    £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.

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    A Leading global Biopharmaceutical company are recruiting for an International Senior Safety Evaluation Physician in Hertfordshire.

    This is a unique opportunity to support the Head of Safety Evaluation and the EU QPPV in early product stages. The company specialises in a range of areas including Oncology and Gastrointestinal.

    Responsibilities:

    • As assigned by the Global Safety Board Chair, to act as General Safety Officer (GSO) to proactively manage the global safety aspects for a specific product, or group of products as defined in company policies and SOPs

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

    • Be responsible for leading safety evaluation for specified products, including signal detection and benefit-risk analysis

    • To lead the safety related aspects of the design and running of clinical studies, including involvement in the protocol production, investigators brochure production, support to the study team, monitoring of safety signals and involvement in the production of the clinical study report.

    • To establish and maintain a high level of familiarity with the local, European, and international pharmacovigilance regulations and guidance relating to drug safety and pharmacovigilance and act as a point of reference for others.

    • Leading the production and amendment of safety information, including product labelling for specified products

    Requirements:

    • The Senior Safety Evaluation Physician will be expected to hold a UK GMC-approved or similar medical registration and have demonstrated experience in post-registration clinical medicine.

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

    • Ideally 4 years’ worth of experience
    • Excellent communications skills.

    • Team player able to provide mentoring and support to less experienced physicians in the Product Safety department in a professional and empathetic manner.

    This Senior Safety Evaluation Physician 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. For more details Please contact Ibraheem Idrissi on +44 (0) 207 220 6204 at click APPLY NOW

  • Competitive Salary and benefits package
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    Skills Alliance has been exclusively retained by a clinical-stage biotechnology company to hire a Senior Analytical Scientist, CMC 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 role is responsible for the creation and authorisation of analytical techniques used for the testing and characterisation of therapeutic drug candidates throughout clinical development. This is a great opportunity to contribute to strategic decision-making on protein behavior. The role reports to the Head of CMC and will be based in Belgium.

    Responsibilities:

    • Involvement in CMC development of pre-clinical and clinical programs and collaboration with team members
    • Lead the creation and validation of analytical testing methods for large molecules release and conduct stability testing in line with relevant regulatory requirements
    • Lead the technology transfer between sites
    • Involvement in analytical testing strategies globally with external and internal stakeholders
    • Support analytical oversight and coordination across sites
    • Contribute expert input into protein formulation and characterisation activities
    • Provide input into statistical tending programs in support of quality reviews for products and specification settings
    • Contribute to writing up quality dossier materials (INDs, IMPDs, BLAs) and creating draft responses for regulatory agency enquiries

    Qualifications:

    • Masters Degree or PhD in relevant field of study
    • Strong technical knowledge in validation, protein characterisation and analytical method development
    • Experience in writing and reviewing registration dossier sections preferred (INDs, IMPDs, BLAs)
    • Strong command of the English language

    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.

  • 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.

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    An exciting opportunity to join a Global Japanese Pharmaceutical company based just outside London, who are recruiting for an Early Pipeline Director.

    This Role will lead global research and development teams to determine potential for discovery compounds for Europe. As well partnering with medical, clinical development and regulatory directors to provide market expertise for analysis and action planning purposes.

    Working from Phase I to Phase III.

    As part of this company, you’ll have the opportunity to gain exposure across multiple therapy and disease areas including Oncology (Solid Tumours) and Neurology (CNS). To further expand your skillset, you will be working alongside some of the world-leading experts in this field.

    Incorporating elements of both Business and Clinical Development.

    Requirements:

    • Essential – Bachelor’s Degree. Scientific/Medical related field
    • Previous Experience within evalution of P1-P3 assets and strategy development
    • Strong understanding of clinical R&D in Pharmaceuticals
    • Strong senior leader engagement skills
    • Ability to travel 30%. International travel is required.


    This is a Fixed Term 12 month contract. It is office-based, offering a competitive salary depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this role, please contact Warda Issa for more details +44 203 823 4158 or click apply.