Medical Affairs Manager

Clinical Research, Medical Affairs, Medical Information/Writing

South East (Excluding London)

£Competitive

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Reference: MAM_WE

Medical Affairs Manager - West Sussex



Star is looking for a Medical Affairs Manager to be responsible for the development and implementation of the Medical Affairs strategy of a specialised pharmaceutical company. This will also include handling Medical Information queries, ZINC review and providing product-specific and SOP training internally and externally, as required.



Main Responsibilities and Accountabilities:



  • Lead the development and implementation of Medical Affairs strategy in designated therapy area across the UK business

  • Provide Medical Affairs expertise and leadership in the designated therapy area cross-functional business team, including completing the medical and scientific review of promotional and non-promotional materials, ensuring compliance with ABPI Code of Practice, statutory and Company requirements

  • Work closely with Head of Medical Affairs to develop and execute Medical Affairs strategic and operational/tactical plans

  • Handle UK Medical Information queries to high professional standard and timely manner

  • Develop and maintain scientific relationships with Key Opinion Leaders to build customer insight

  • Develop in-depth knowledge of product literature and publications (and competitor) relevant to therapy area to high standard

  • Provide disease area, product specific and SOP training internally and externally as required

  • Contribute to the development of and periodically review of relevant SOPs

  • Provision of information to NICE/Scottish Medicines Consortium and other relevant external government/regulatory bodies as and when requested to high professional standard

  • Ensuring compliance with ABPI Code of Practice, global SOPs, policies and quality system requirements as appropriate to the position including: Prompt reporting of all Adverse Reactions, Product Technical Complaints or Deviations according to UK SOPs, Completion of required training and maintenance of personal training records

  • Providing assistance as required in the event of a field action, as determined by the Recall Team, and to act as Deputy Recall Coordinator as necessary



Education:



  • UK Registered Pharmacist

  • ABPI registered medical signatory/final signatory



Experience:


Minimum:



  • Two years in pharmaceutical Industry in Medical Information, Pharmacovigilance and/or Regulatory Affairs

  • Expected to be fully conversant with national medical regulations

  • Code of Practice

  • Reporting of Adverse Events requirements

  • Fully conversant with AE and SAE definitions, collection, reporting

  • Post-marketing surveillance, spontaneous reporting

  • Product recall and withdrawal process and SOPs



Apply for this opportunity now via this website, or call Will on 01628 581 240!




Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.


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