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Covering the following locations: Hemel

Purpose: To provide internal and external medical support by being an expert on product, patient treatment trends and scientific activities within the disease area, ensuring compliance with SOPs as well as legal and ethical standards.

Accountabilities / Measures:

1. Medical Affairs input at UK and European level to ensure UK representation in European development plans and lifecycle management plans.
" Participate and be an active member in the UK Medical and Brand teams in order to provide medical input into Brand Strategy.
" Lead local strategies and ensure alignment with European strategies.
" Ensure alignment with UK Marketing and Regulatory before communicating to European team.
" Be an active member of the European medical team, thus ensuring that UK needs are represented at a European and Global level.
" Ensure appropriate participation in European/global studies.
" Identify and follow up PMT's, manage IITs, co-ordinating budget and communication to the European medical team.
" Manage and co-ordinate medical brand budgets liaising with finance as required.
" Actively lead on scientific and medical support to marketing and regulatory plans based on analysis of medical literature and other information.
" Coordinate with other medical functions to ensure aligned strategy.
" Develop and maintain direct contact with external experts to gather insights and input on treatments/DA and develop strong peer to peer scientific partnerships with them in order to assess unmet needs.
" Provide medical input for compounds in development.

2. Provides expert support relating to product, patient treatment trends and scientific activities within disease areas.
" Continuously updates knowledge of products, patient treatment trends and scientific activities within the Disease Area.
" Provides clear, concise and appropriately tailored communications relevant to the audience and the subject matter to ensure a positive outcome.
" Communicate medical benefits and risks for all products within the disease area in an accurate, balanced, fair objective manner.
" Collaborate with Medical Information personnel to provide timely and informative responses to scientific enquiries from external customers and internal partners which accurately reflect scientific data.
" Prepare and/or contribute as appropriate to the initial and ongoing medical/scientific disease area and product-specific training of internal UK customers (Sales force, etc) in collaboration with Learning and Development, enabling the field sales teams to understand and convey the scientific benefits of a Brand appropriately in a medically accurate and compliant manner.

3. Assess promotional materials to ensure that all claims are supported by scientific data and presented in an accurate, fair and balanced manner, ensuring compliance with SOPs as well as legal and ethical standards
" Ensure compliance with SOPs, GCP, GMP and ICH as well as legal and ethical standards.
" Assess, review and approve all promotional materials to ensure that all claims are supported by scientific data and are presented in a fair, accurate and balanced way in compliance with the ABPI Code of Practice.
" Review European created materials/programmes, assess and ensure local applicability.
" Act as a role model who demonstrates consistent ethical and professional behaviour at all times.
" Alert management e.g. Medical Director of any compliance issues.
" Ensure all communications to sales force are accurate and approved in accordance with the ABPI code requirements

4. Continuously develop own professional skills and knowledge in order to make a valued contribution to the development of individual and team performance at harnessing this knowledge by providing a broad perspective to strategic discussions
" Demonstrates a commitment to own development by showing advanced presentation skills and expertise in behavioural techniques and product and therapy area knowledge.
" Responsible for maintaining own clinical knowledge and in doing so ensure that key information is communicated throughout
5. As Local Safety Officer, maintain the UK Pharmacovigilance System
" In collaboration with the Deputy Local Safety Officer: Receive and assess adverse event reports from Health Care Professionals (HCP), patients, non-interventional studies or the MHRA and follow up with the reporter if additional information is required; complete ADR forms and log these on a local tracking system.
" Send the completed case report to Clinical Safety and Pharmacovigilance at DSE within stipulated regulatory timelines.
" Maintain accurate documentation relating to Adverse Events.
" Carries out reconciliation with DSE in order to ensure compliance with PV legal framework.
" Provide PV training to all new starters and refresher training to all employees on an annual basis.
" Write and send communications on PV and Regulatory updates/issues to head office and field based teams as and when required.
" Receive and assess Product Defect Reports, develops response and sends to DSE, appropriate manufacturers and customers.
" Proof read SMPCs and PILs to ensure compliance with safety data.
" Ensure the PV, Product Defect and associated Training SOPs are up to date and reflect regulatory and legal guidelines.

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* Salary Guide
£75,000 - £95,000
Job Ref: 65566

Tom Summerbell

Recruitment Consultant +44 1494 818 037

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