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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, 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 Oslo, Norway (or London, UK). They will offer a very competitive salary – please get in touch for more details.

    Skills Alliance are retained to fill this position. Please contact Mark Anderson for more details +44 207 220 6209.

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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, 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 Oslo, Norway (or London, UK). They will offer a very competitive salary – please get in touch for more details.

    Skills Alliance are retained to fill this position. Please contact Mark Anderson for more details +44 207 220 6209.

  • UK

    £50000 - £70000 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, 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 (Euston). The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £50-60K depending on experience + full benefits package.

    Skills Alliance are retained to fill this position. Please contact Mark Anderson for more details +44 207 220 6209.

  • UK

    £50000 - £70000 per annum, Excellent package
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    Share

    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, 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). The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-70K depending on experience + full benefits package.

    Skills Alliance are retained to fill this position. Please contact Mark Anderson for more details +44 207 220 6209.

  • €65 - €80 per hour
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    I am currently supporting an innovative Medical Device Company with an MDR Project, they are currently seeking a Lead Auditor:

    • As a Lead auditor, you check the quality management of medical device manufacturers based on the EC Directive 98/79 / EC and EN ISO 13485.
    • As an expert, you check product documentation (technical documentation) as part of the conformity assessment procedure based on the relevant standards.

    Your profile

    • You have a scientific or medical engineering degree or a specialist training in the field of laboratory medicine and have several years of professional experience in the field of in-vitro diagnostics (e.g. in the development, production or quality control of in-vitro diagnostics or in the field of laboratory medicine).
    • Previous experience with a Notified Body
    • Experience in conducting audits for either Active, non-active, dental or combination products
    • You have business fluent German and English.
    • They are characterized by flexibility and resilience, are able to work in a team and enjoy their job.
    • Experience in supporting Medical Device company with the transition from MDD to the new EU MDR (EU Medical Device Regulation).

    If you would like to find out more about this position please contact me:

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

  • UK

    Up to £40,000 + Strong bonus + Extensive Benefits Package
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    My client is a leading global pharmaceutical company who is looking for a Senior TMF specialist to join their exciting team. This is an opportunity to join one of the leading players in the Neurology and Oncology field, being actively part of a highly dynamic clinical team.

    Key Responsibilities:

    • Monitor and maintain clinical trial documents and data for global scope trials across all clinical phases
    • Meeting and liaising with study teams from both the UK and the US
    • Quality Control (QC) of studies including starting the study, maintaining the QC and close out of the study
    • Liaising with the company vendor and their CRO, maintaining stakeholder management

    Key Requirements:

    • At least 4 years in the pharmaceutical industry, working within clinical development/operations
    • Strong experience with clinical document management (TMF,eTMF and QC required)
    • Excellent organisational and communication skills
    • Life Science degree to BSc level minimum

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

  • UK

    Strong Competitive Salary + Excellent Bonus and Benefits
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    Skills Alliance is partnered with a global leading Medical Devices and Technologies company who are looking for an experienced Clinical Research Associate to join their exciting clinical division.

    You would be responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, SOPs, regulatory standards, and business policies. 2 Medical device trials in Pain and Cardiovascular studies would be the area of focus for this CRA.

    Most of the monitoring activities are done remotely, requiring little travel maybe once a week or month at times.

    Requirements for this role:

    • A minimum of 2 years of clinical monitoring experience as a CRA for medical device trials
    • Excellent CTMS experience due to the complexity of the client’s systems
    • Minimum of a Bachelors degree in a life science subject or another related discipline
    • Excellent communication skills, both written and oral

    This is a permanent position and fully field/home-based in the UK. Monitoring visits are mostly remote as mentioned.
    A full job description is available on request through Arturo Maldonado
    Alternatively, contact me on 0203 668 3963 for a confidential discussion on this and other opportunities

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    A Leading global Biopharmaceutical company are recruiting for a Regulatory Affairs Manager / Senior Manager position based in the Netherlands.

    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 Affairs Manager / Senior Manager position comes with a competitive salary and benefit package.

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

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    Our client is very innovative and dynamic biopharmaceutical company based in Basel area. For their Preclinical Pharmacokinetics and Drug Metabolism Department, we are seeking a talented individual for their Metabolite Identification laboratory dealing with the characterization of new drug candidates in a position of

    Research Technician / Scientific Associate

    Responsibilities

    • Development of analytical methods for the generation of metabolic profiles from in vitro and in vivo studies
    • Generation of in vitro metabolic profiles to support a selection of suitable animal species for toxicology testing
    • Identification of metabolizing enzymes and determination of enzyme kinetic parameters
    • In vivo metabolic profiling and excretion balance studies
    • Performing in vitro incubations in enzymatic systems and cell culture
    • Biochemical assays to assess reactive metabolite formation
    • Metabolite structure identification
    • Ability to efficiently plan, organize and clearly document experimental work in a multidisciplinary environment

    Requirements

    • Technical diploma, B.S. or M.S. in chemistry, pharmacology, biology or other relevant science disciplines
    • Strong experimental background in in-vitro and in vivo metabolism
    • Profound experience with HPLC coupled to different detection methodologies including radiodetection and mass spectrometry
    • Experience with biochemical assays
    • Basic knowledge in cell culturing (biological safety level 2)
    • Good communication and organizational skills and the ability to work in a team
    • Good command of English


    For more information please contact Maja Vidovic, Recruitment Consultant DACH:

    M: 0041 22 518 82 49

  • UK

    £35000 - £40000 per annum, Excellent Bonus + Extensive Benefits Package
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    Share

    Skills Alliance is partnered exclusively with a leading biopharmaceutical company in Central London who are looking for a Senior Clinical Trials Associate (CTA) to join their exciting Clinical Operations team in the UK.
    This client is a pioneer and leader in advanced treatments in the Hepatology space and treating life-threatening Liver Disease conditions. You would be reporting directly to the Director of Clinical Operations and helping support and execute the clinical trials from start-up through execution and the preparation of study reports and regulatory filings.

    Key Requirements:

    • Minimum of 2 years’ experience as a CTA/CRA in pharmaceutical, biotechnology or CRO environment.
    • Competency in ICH-GCP and a strong interest in clinical research
    • Bachelor’s degree, nursing qualification, or equivalent, in a biomedical, life science or related field of study.

    This is a fantastic opportunity to join a leading organisation in the biopharmaceutical space and expand your clinical research career. This company offers excellent progression routes into clinical monitoring or project and study management.

    A full job description is available on request along with further package details. Please send your CV in word format to Arturo Maldonado or call 0203 668 3963 for more information.

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    I am currently partnered with a Global Medical Device Company who are looking to add a Service and Repair Engineer to their team.

    Location: Hull

    Contract Length: 6 months (with a view to extend)

    Start: February 2020

    My client is looking for a candidate with:

    – Bachelor’s Degree in biomedical engineering, Integrated Logistics Support, Electronics Engineering or Mechanical Engineering

    – 3 years’ experience within the Medical Device Industry

    – Experience in Reliability Engineering, particularly in reliability tools/techniques

    – Experience in Change Management or Design Control

    The description of the role is stated below:

    – To take a leading role in SOP generation and revision to maintain compliance with cGMP’s.

    – To monitor, extrapolate and trend Service & Repair data using statistical techniques to recommend root cause analysis, investigations and / or CAPA activities.

    – To lead the execution of Change Control projects for Service & Repair.

    – To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.

    – To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.

    Please let me know if this would be a role of your interest.

    You can contact me via email or phone

    Email: shakir.hossain (at) skillsalliance.com

    Phone: +44 (0) 207 220 6232

  • UK

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

    Key Responsibilities:

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

    Key Requirements:

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

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

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

  • Apply

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    Medical Director – Cardiovascular – UK and Ireland

    I am currently working with a client of ours who are looking to take on a qualified medic to join their UK and Ireland medical affairs team as a Medical Director for their cardiovascular portfolio.

    As a globally renowned pharmaceutical company, our client are growing their cardiovascular portfolio as well as taking on new therapeutic areas to further their commitment to providing innovative pharmaceutical products across the globe.

    This is a highly operational role and will involve the leadership of medical affairs, regulatory affairs, medical information, pharmacovigilance and quality assurance teams, as well as making sure all medical affairs activities are in line with the ABPI and IPHA codes of practice.

    Our client are looking for GMC registered medics with medical affairs experience. You will also have experience in leading a team of medically-qualified professionals, as well as oversight and leadership of cross-functional teams.

    For more information on this opportunity or any similar opportunities, please contact Chanel Hicken on 0207 220 6206 or email your CV and we can arrange a time for a confidential discussion about your next career move.

  • UK

    £65000 - £80000 per annum, car allowance + bonus
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    Share

    Medical Final Signatory Manager – BRAND NEW ROLE, EU Wide Responsibility

    One of our clients are building out their European medical affairs team and are looking for an experienced final signatory professional to join the business to take on Final Signatory responsibilities across the business.

    Our client are a mid-sized pharmaceutical company, globally renowned for their work across most CNS and oncology and are due to launch a CNS product within the next 18 – 24 months. With this in mind, they require a dedicated final signatory professional to join the team to review anad examine both promtional and non-promotional materials across their European products/portfolios.

    For this position, our client are looking for either GMC or GPhC registered medics or pharmacists with final signatory experience.

    As part of this role, you will be working closely with the Head of Medical to ensure positive outcomes are achieved across the business and working on medical remediation across the European business.

    For more information about this position or any similar opportunities, please contact Chanel Hicken 0207 220 6206.

  • UK

    £90000 - £100000 per annum, car allowance + benefits
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    EU Medical Manager – Brand new team, EU responsibility

    Skills Alliance are currently partnered with a mid-sized pharmaceutical company who are looking to build out their European medical affairs team and are therefore looking for medical professionals to join their team as an EU Medical Manager.

    This is a great opportunity for anyone who is looking to take on above-country experience in order to provide input into the EU life cycle management of our clients’ products. You will be involved across all EU medical affairs activities as well as working very closely with the EU commercial team as well as the UK affiliates.

    Due to the build out, there are 3 positions available across a number of therapeutic areas including: neurology, nephrology and general medicine which encompasses oncological products. Depending on which portfolio you work with, you may also get the chance to take on product launch and/or pre-launch experience thereby enhancing your skillset.

    Our client are renowned for their work across these therapeutic areas, most notably within the field of oncology and neurology, hence these roles are business critical.

    If you’re a qualified, GMC registered medic with medical affairs experience in the industry and looking for your next career move, give me a call and we can discuss these positions or any other similar opportunities I may have available that could be of interest to you.

    Email me or call me on 0207 220 6206 and we can have a confidential discussion about how I can help with your job search.

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    A leading pharmaceutical company are recruiting for a Key Account Manager, covering South West England in Neurology. (Secondary Care)

    You would be responsible to sell niche pharmaceutical products to healthcare specialists, whilst always representing the company to high ethical principles.

    You will work with and report into your Regional Account Manager. You will create solid customer relationships assembled on your perception of their requirements and your capacity to demonstrate your integrity by filling those requirements.

    You will exhibit a high degree of knowledge within Neurology and utilize a variety of promotional strategies to successfully execute them. Contributing to the sales team and wider account teams you work within, whilst building and securing business strategies and conveying them successfully.

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

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

  • UK

    £30 - £40 per hour
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    I am currently on a Regulatory Affairs Associate Position for a 12-month contract.

    My client is a global research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need.

    Location: Cambridge is the preferred location but would consider Stockley Park

    Essential Duties and Job Functions

    • Support post-marketing activities for the preparation of regulatory submissions for HIV medicinal products via the EU centralised procedure, which may include, but is not restricted to variations, PSURs/RMPs, responses to questions and renewals.

    • Preparation and/or coordination of regulatory labelling variation submissions

    • Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licences in international territories including the review and provision of accurate labelling translations.

    • Support the preparation/ maintenance of clinical trial applications, ROW core dossiers and response to ROW questions.

    • Participate in regulatory HIV team meetings, product team meetings and departmental meetings.

    • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.

    • Support the HIV Int RA team as required.

    Would this be a role of your interest?

    If so, please let me know. You can contact me via:
    Email: shakir.hossain (at) skillsalliance.com
    Phone: +44 (0) 207 220 6232
    LinkedIn: Shakir Hossain

  • UK

    £90000 - £100000 per annum, car allowance + benefits
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    EU Medical Manager – Brand new team, EU responsibility

    Skills Alliance are currently partnered with a mid-sized pharmaceutical company who are looking to build out their European medical affairs team and are therefore looking for medical professionals to join their team as an EU Medical Manager.

    This is a great opportunity for anyone who is looking to take on above-country experience in order to provide input into the EU life cycle management of our clients’ products. You will be involved across all EU medical affairs activities as well as working very closely with the EU commercial team as well as the UK affiliates.

    Due to the build out, there are 3 positions available across a number of therapeutic areas including: neurology, nephrology and general medicine which encompasses oncological products. Depending on which portfolio you work with, you may also get the chance to take on product launch and/or pre-launch experience thereby enhancing your skillset.

    Our client are renowned for their work across these therapeutic areas, most notably within the field of oncology and neurology, hence these roles are business critical.

    If you’re a qualified, GMC registered medic with medical affairs experience in the industry and looking for your next career move, give me a call and we can discuss these positions or any other similar opportunities I may have available that could be of interest to you.

    Email me or call me on 0207 220 6206 and we can have a confidential discussion about how I can help with your job search.

  • UK

    £65000 - £80000 per annum, car allowance + bonus
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    Job
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    Share

    Medical Final Signatory Manager – BRAND NEW ROLE, EU Wide Responsibility

    One of our clients are building out their European medical affairs team and are looking for an experienced final signatory professional to join the business to take on Final Signatory responsibilities across the business.

    Our client are a mid-sized pharmaceutical company, globally renowned for their work across most CNS and oncology and are due to launch a CNS product within the next 18 – 24 months. With this in mind, they require a dedicated final signatory professional to join the team to review anad examine both promtional and non-promotional materials across their European products/portfolios.

    For this position, our client are looking for either GMC or GPhC registered medics or pharmacists with final signatory experience.

    As part of this role, you will be working closely with the Head of Medical to ensure positive outcomes are achieved across the business and working on medical remediation across the European business.

    For more information about this position or any similar opportunities, please contact Chanel Hicken 0207 220 6206.

  • Apply

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    Share

    Medical Director – Cardiovascular – UK and Ireland

    I am currently working with a client of ours who are looking to take on a qualified medic to join their UK and Ireland medical affairs team as a Medical Director for their cardiovascular portfolio.

    As a globally renowned pharmaceutical company, our client are growing their cardiovascular portfolio as well as taking on new therapeutic areas to further their commitment to providing innovative pharmaceutical products across the globe.

    This is a highly operational role and will involve the leadership of medical affairs, regulatory affairs, medical information, pharmacovigilance and quality assurance teams, as well as making sure all medical affairs activities are in line with the ABPI and IPHA codes of practice.

    Our client are looking for GMC registered medics with medical affairs experience. You will also have experience in leading a team of medically-qualified professionals, as well as oversight and leadership of cross-functional teams.

    For more information on this opportunity or any similar opportunities, please contact Chanel Hicken on 0207 220 6206 or email your CV and we can arrange a time for a confidential discussion about your next career move.

  • UK

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

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

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

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

  • UK

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

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

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

    Key Facts:

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

    Key Requirements:

    • Strong independent monitoring experience as a CRA in a commercial setting (CRO or Pharma)
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

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

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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

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    A Leading global Biopharmaceutical company are currently on the lookout for a CMC Regulatory Affair Senior Associate position covering the ROW territories, located in Cambridge.

    This is an opportunity to be a part a specialised global Regulatory Affairs team delivering the CMC Quality components for clinical trial applications, new licence applications and post approval submissions in International “Rest of World” territories including Asia, Latin America, Middle East, Eastern Europe and Africa. The opportunity will offer you the chance to grow your Regulatory Affairs expertise across a wide range of territories with diverse regulatory requirements and processes and an evolving regulatory landscape.


    Responsibilities:

    • Prepare the Quality sections of INDs/IMPDs, new MAAs, CMC variations and renewals for submission in Rest of World (RoW) territories.
    • Ensure that dossiers meet ICH and local regulatory requirements.
    • Co-ordinate the preparation of responses to CMC questions from regulatory authorities.
    • Work with pharmaceutical development, manufacturing, QA and external partners to deliver CMC Quality components for regulatory submissions in ROW territories in accordance with corporate objectives or post-licensing commitments.
    • Liaise with Gilead’s local Affiliates, distributors or agents to define/clarify CMC submission requirements.
    • Provide advice to pharmaceutical development and manufacturing colleagues on RoW regulatory requirements for new submissions and for post approval change management.
    • Develop expertise in assigned product areas and become Subject Matter Expert (SME) for assigned CMC Regulatory activities

    Requirements:

    • Typically requires a BA or BS degree in a relevant discipline and relevant experience in CMC Regulatory Affairs.
    • Experience in the preparation and maintenance of CMC components of regulatory submissions.
    • General understanding of CMC regulatory requirements and quality guidelines, including ICH and regional requirements.
    • Excellent organization skills and ability to work on a number of projects with tight timelines.
    • Excellent verbal and written communication skills and interpersonal skills.

    This Regulatory Affair Senior Associate is an office-based position with 40% home working. It Is a permanent role offering a competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi on 0207 220 6204 for more details or click APPLY NOW

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    A global pharmaceutical company are currently sourcing for a Regulatory Affairs Manager located in their Cambridge offices. This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability.

    Responsibilities:

    • Review, incl. advising and assessment of registration dossiers (esp. Module 1) prior to each submission step during the filing process for in-licensed developments with UK as the leading country
    • Preparation (esp. Module 1), submission and coordination of national and European registration procedures
    • Preparation, submission, coordination and monitoring of national phases of European Registration procedures, including national texts
    • Preparation (Module 1), Submission and Coordination of national and European variations and renewal procedures and/or response documents to deficiency letters
    • Maintenance and communication with internal and external contacts and interfaces, e.g. European Authorities, European affiliates, Headquarter and partners/customers (e.g. NHS, MHRA)

    Requirements:

    • Study / Degree in Pharmaceutical Sciences, Life Sciences or Natural Sciences with at least three-year experience in EU Regulatory Affairs incl. New Applications,
    • Experience with MHRA is preferred
    • Experience in project management is beneficial
    • Fluent in English is essential as it is used as the main communication language
    • Good knowledge of MS Office and of RA eSubmission tools are an advantage

    This Regulatory Affair Manager 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

  • UK

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

    Responsibilities:

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

    Requirements:

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

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

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

  • UK

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

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

    Responsibilities:

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

    Requirements:

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

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

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

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

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

    Responsibilities:

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

    Requirements:

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

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

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

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

    Responsibilities:

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

    Requirements:

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

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

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

  • UK

    £55000 - £60000 per annum
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    Would you be interested in working with a leading global CRO company as a Senior Regulatory Affairs Associate in West Sussex. You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

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

    Responsibilities:

    • Management, preparation, assembly, submission and full oversight for:
    • Clinical Trial Authorisation Applications (CTAA) and amendments.
    • All other regulatory and patient facing documents required to support ongoing approval of clinical trials, including all required translations, in accordance with the required current legislation and guidelines.
    • Tracks, reports, files and maintains oversight of CTAA and amendment submission / approval progress in electronic trial master files (eTMF), clinical trials management system (CTMS) or other applicable systems.
    • Ensures all CTAAs and amendments are submitted in accordance with clients’ timelines.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by RAs and ECs.

    Requirements:

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

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

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

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    A global pharmaceutical company are currently sourcing for a Regulatory Affairs Manager located in their Yorkshire offices. This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability.

    Responsibilities:

    • Review, incl. advising and assessment of registration dossiers (esp. Module 1) prior to each submission step during the filing process for in-licensed developments with UK as the leading country
    • Preparation (esp. Module 1), submission and coordination of national and European registration procedures
    • Preparation, submission, coordination and monitoring of national phases of European Registration procedures, including national texts
    • Preparation (Module 1), Submission and Coordination of national and European variations and renewal procedures and/or response documents to deficiency letters
    • Maintenance and communication with internal and external contacts and interfaces, e.g. European Authorities, European affiliates, Headquarter and partners/customers (e.g. NHS, MHRA)

    Requirements:

    • Study / Degree in Pharmaceutical Sciences, Life Sciences or Natural Sciences with at least three-year experience in EU Regulatory Affairs incl. New Applications,
    • Experience with MHRA is preferred
    • Experience in project management is beneficial
    • Fluent in English is essential as it is used as the main communication language
    • Good knowledge of MS Office and of RA eSubmission tools are an advantage

    This Regulatory Affair Manager is a permanent role offering a competitive salary and benefit package located in Yorkshire.

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

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    A Leading global full service CRO are currently recruiting for a Regulatory Affair Manager or Associate Director in their London offices.

    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 Oncology, Cardiology, Metabolic diseases and many more.

    Responsibilities:

    • Project management focus to facilitate full global regulatory submissions which will include:
    • Tracking, compiling, and maintaining full regulatory applications including initial INDs and NDAs;
    • Maintaining timelines for full regulatory submissions;
    • Providing regulatory advice and guidance to other departments to ensure compliance with EMA regulations and requirements;
    • Interaction with EMA and other regulatory agencies;
    • Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the EMA; and
    • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

    Requirements:

    • Bachelor’s degree and significant regulatory affairs experience;
    • CMC experience preferred;
    • Experience with EMA and other regulatory agencies is preferred;
    • Strong computer skills, project management skills, and a high attention to detail;
    • Strong communication skills (both written and oral); and
    • Must be a team player with a global regulatory mindset.
    • This position may require supervision of junior level staff.

    This Regulatory Affair Manager or Associate Director position is a permanent role offering a highly competitive salary + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi on 0207 220 6204 or click APPLY NOW

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

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

    Responsibilities and Tasks


    – Support the development and update of global publication plans across multiple therapeutic areas;
    – Facilitate the timely and ethical delivery of planned publications
    – Manage review process for Publications

    Required Qualifications and Experience


    – Advanced Scientific Degree
    – 3+ years of relevant Publication Management experience within pharmaceutical industry and/or medical communication agency
    – Thorough knowledge of industry and publication best practices and relevant guidelines
    – Ability to Develop, implement and/or maintain publication processes, standards and systems
    – Fluent in English, native English preferred
    – Medical Writing Experience preferred

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

  • £0 - £490 per day
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    The Associate Director, TA Project Manager will provide specialist expertise to develop consistent and effective execution of projects for the TAs, the Core Medical Teams (CMT) and Core Medical Plans (CMP) across multiple therapeutic areas. This role will be responsible for multiple year planning and execution of projects. This position will drive the department efforts to align with internal stakeholders to ensure best practices are used consistently within the region and across the EMEA affiliates for project management. This position will also have TA project management responsibilities as follows:

    1. Provides leadership in the operational strategy by ensuring the completion of the activities foreseen in the Core Medical Plans (CMPs) in order to meet project, department and organizational objectives.

    2. Responsible for the support of the TAs and the CMTs in overseeing budget of projects.

    3. Responsible for the implementation of the CMP and the brand plan for assigned global/ 1 region and 1 country compounds in one or two TAs within MA,EMEA.

    4. Collaborates with Regional Clinical Operations to ensure the execution of projects.

    annelie.murray at skillsalliance.com

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    Medical Director – Cardiovascular – UK and Ireland

    I am currently working with a client of ours who are looking to take on a qualified medic to join their UK and Ireland medical affairs team as a Medical Director for their cardiovascular portfolio.

    As a globally renowned pharmaceutical company, our client are growing their cardiovascular portfolio as well as taking on new therapeutic areas to further their commitment to providing innovative pharmaceutical products across the globe.

    This is a highly operational role and will involve the leadership of medical affairs, regulatory affairs, medical information, pharmacovigilance and quality assurance teams, as well as making sure all medical affairs activities are in line with the ABPI and IPHA codes of practice.

    Our client are looking for GMC registered medics with medical affairs experience. You will also have experience in leading a team of medically-qualified professionals, as well as oversight and leadership of cross-functional teams.

    For more information on this opportunity or any similar opportunities, please contact Chanel Hicken on 0207 220 6206 or email your CV and we can arrange a time for a confidential discussion about your next career move.

  • UK

    £90000 - £100000 per annum, car allowance + benefits
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    EU Medical Manager – Brand new team, EU responsibility

    Skills Alliance are currently partnered with a mid-sized pharmaceutical company who are looking to build out their European medical affairs team and are therefore looking for medical professionals to join their team as an EU Medical Manager.

    This is a great opportunity for anyone who is looking to take on above-country experience in order to provide input into the EU life cycle management of our clients’ products. You will be involved across all EU medical affairs activities as well as working very closely with the EU commercial team as well as the UK affiliates.

    Due to the build out, there are 3 positions available across a number of therapeutic areas including: neurology, nephrology and general medicine which encompasses oncological products. Depending on which portfolio you work with, you may also get the chance to take on product launch and/or pre-launch experience thereby enhancing your skillset.

    Our client are renowned for their work across these therapeutic areas, most notably within the field of oncology and neurology, hence these roles are business critical.

    If you’re a qualified, GMC registered medic with medical affairs experience in the industry and looking for your next career move, give me a call and we can discuss these positions or any other similar opportunities I may have available that could be of interest to you.

    Email me or call me on 0207 220 6206 and we can have a confidential discussion about how I can help with your job search.

  • UK

    £65000 - £80000 per annum, car allowance + bonus
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    Medical Final Signatory Manager – BRAND NEW ROLE, EU Wide Responsibility

    One of our clients are building out their European medical affairs team and are looking for an experienced final signatory professional to join the business to take on Final Signatory responsibilities across the business.

    Our client are a mid-sized pharmaceutical company, globally renowned for their work across most CNS and oncology and are due to launch a CNS product within the next 18 – 24 months. With this in mind, they require a dedicated final signatory professional to join the team to review anad examine both promtional and non-promotional materials across their European products/portfolios.

    For this position, our client are looking for either GMC or GPhC registered medics or pharmacists with final signatory experience.

    As part of this role, you will be working closely with the Head of Medical to ensure positive outcomes are achieved across the business and working on medical remediation across the European business.

    For more information about this position or any similar opportunities, please contact Chanel Hicken 0207 220 6206.

  • UK

    Competitive
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    An exciting opportunity for an experienced Administrative Assistant to join a global specialist medical device company based in Oxford.

    You will be providing support to the marketing department, assisting with organising internal meetings (on site or off site), In coordination with the Sr. Marketing Manager, process invoice payments for marketing and sales activities and support the marketing team with general administrative tasks as required

    My client is a globally renowned medical devices company covering a number of product portfolios. As part of this international company, you’ll have the opportunity to gain international exposure to further expand your niche skillset and will be working alongside some of the world-leading experts in this field.

    Although a global company, they are still going through a huge period of growth at the moment with an ever-growing pipeline, thereby giving you the opportunity to progress your career quickly once within the business.

    Requirements:

    • Minimum of 2 years’ experience supporting sales and/or marketing teams
    • Experience in healthcare and/ or medical devices preferred but not essential
    • Strong organizational skills and ability to work in a team environment providing cross-functional support

    This is a permanent and full-time position. It is office-based in Oxford 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 NOW!

  • UK

    £50000 - £70000 per annum, Excellent Bonus + Extensive Benefits Package
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    Skills Alliance are partnered with an exciting Biotechnology company in London and Hertfordshire who are looking for a Clinical Project Manager OR Senior Clinical Project Manager to join their exciting Clinical Operations team. This exciting biotech is focused on Advanced Therapies such as Cell and Gene Therapy and is currently undergoing a period of exponential growth meaning their are and will be amazing developmental opportunities for personal growth into Board of Director level.

    Key Responsibilities:

    • Working with the Director of Clinical Operations and team to support the execution of the deliverables for the clinical studies whether interventional or observational
    • Monitoring of study deliverables
    • Performing protocol-related site management activities
    • Participating in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans
    • Supporting vendor relationships

    Key Requirements:

    • Strong clinical project management experience in a Biotechnology (preferred) or Pharmaceutical organisation
    • Experience of working in complex therapeutic areas (Oncology, Neurology, Ophthalmology, Advanced Therapies etc.)
    • International PM experience in Europe across multiple countries
    • Life Science degree at Bachelors level minimum

    Skills Alliance are the preferred suppliers for this role. Please contact Arturo Maldonado for more information and a full job description on 02036683963

  • UK

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

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

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

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

  • UK

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Trial Manager or Clinical Study Manager role based in Hertfordshire offering an excellent salary and package.

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

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

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

  • UK

    £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

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Trial Manager or Clinical Study Manager role based in Hertfordshire AND/OR London offering an excellent salary and package.

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

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

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

  • USA

    Competitive Pay + Benefits
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    We are working with a Biopharma company in Seattle in search of a Director of Quality Control to add to their team full time, on-site. This company has a diverse pipeline focused on small molecule and protein therapeutics targeting CNS disorders and oncology. Let’s connect and set up a call to discuss!

    We are working with a Biopharma company in Seattle who are in search of a Director of Quality Control to add to their team full time, on-site. This is a stable and well-regarded company with a diverse pipeline focused on small molecule and protein therapeutics targeting CNS disorders and oncology. This person will lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP Biologics and small molecule products. Lead and manage QC staff including hiring, developing, evaluating and goal setting. Oversee GMP clinical and commercial stability planning, execution, data analysis and data trending in support of product expiry/shelf life determination.

    • Biologics/Large Molecule
    • Experience with Analytical Methods under QC
    • Experience with CMO
    • Worked in GMP

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