Description
Purpose:
To be the Therapy Area clinical expert delivering medical insight and governance into the Brand, in order to meet Brand and Therapy Area objectives through Medical Excellence
Therapy Area: Diabetes
- Ensure the patient is at the heart of the Brand in all activities
- Lead the development and implementation of Clinical Advisory Boards
- Develop and leverage medical insight from external and internal customers into the Medical and Therapy Area plans
- Develop and maintain scientific relationships with key physicians to build customer insight and develop strategic partnerships
- Visit external customers to resolve clinical/technical queries and according to therapy area demand
- Provide expert medical input into key market access activities (NICE/SIGN submissions etc)
- Support the delivery of key existing and emerging Life Cycle initiatives (MC3 etc.) by providing expert medical advice and customer insight
- Support the development and monitoring of named patient programmes (eg Patient Review Services)
- Lead the development of clinical summaries for Medical Affairs, Brand Team and Field Force from key relevant recently published papers as appropriate
- Act as a role model and ensure ethical/professional behaviour
- Ensure that AZ UKMC activities comply with standards for medical governance and duty of care
- Responsible for the medical review of adverse event reports and pharmacovigilance activities*
- Provide expert medical input into issues management (eg product withdrawals, safety alerts, etc.)
- Drive intelligent compliance through adherence to the 2008 ABPI Code of Practice and PAGB Code as applicable.
- Contribute to the development and execution of Medical Brand Plans to support Brand objectives
- Ensure Medical Affairs input into the concept development of Brand promotional materials
- Responsible for medical approval of all media and core and by exception, non-core brand related promotional materials - artwork and final sign-off*
- Develop & leverage medical insight through attendance at scientific meetings to further develop own knowledge base but in line with clear business need
- Lead in case for the defence/challenge of promotional activities for ABPI
- Provide expert medical opinion into regulatory submissions to maximise the impact to the UK business
- Accountable for the medical review and sign-off of all CTX submissions for the Brand and TA products*
- Provide expert medical input into the labelling process (SmPC, PIL etc.)
- Support the development and quality execution of the Patient Risk Management Plan for the allocated Brand.
- Support Regulatory Affairs with MHRA activities & PAGB activities
- Support Medical Affairs Scientist in driving the delivery of local strategic claim plans
- Lead on the design and development of local/Regional clinical studies in line with the Medical Brand Strategy
- Act as the responsible study physician for all local clinical studies and resolve any emerging medical issues*
- Support or deputise for the Medical Affairs Leader in delivering Medical and Regulatory input into the Brand Strategy
- Develop and drive interactions with Global and EU Medical to maximize UK influence on Global strategy
- Support the coordination and enhancement of Medical Affairs interactions with CRG, Global and ISMO in relation to early phase development
- Deputise for the Medical Affairs Leader as and when appropriate
- Ensure regular communication of best practice and facilitation of knowledge sharing across the Medical Affairs TA team
- Input into Medical Affairs Therapy Area Team performance metrics
- Promote best practice by sharing successes and by helping to identify/resolve issues with other Brand teams
Essential:
- Medicine [GMC registered] and/or extensive relevant clinical experience with appropriate professional qualification
- Technical specialist requirements may vary according to business need
Desirable:
- Associate of the Faculty of Pharmaceutical Medicine
- Eligible or studying for the Diploma in Pharmaceutical Medicine
- Higher Medical Qualification eg MRCP, MRCGP, MRCS, MD/PhD