About You
Due to our upcoming product launches, Vifor Pharma is hiring a Medical Affairs Lead to join their medical function in their UK affiliate located in Staines-upon-Thames.
The Medical Affairs lead will need to act as a UK final medical signatory.
Main Accountabilities
- Strong member of the medical leadership team, shaping the development of the local medical strategy via therapeutic area clinical knowledge and insight from HCP interactions
- Development and compliant implementation of the annual country TA medical plan, ensuring alignment with the cross functional TA strategic imperatives as well as Global TA medical plans
- Closely collaborate with colleagues in the development and implementation of the local TA strategy
- Establish effective clinical engagement with external medical experts, medical / scientific associations and other external stakeholders (e.g. patient advocacy groups, payer organizations)
- Develop clear educational strategies for country medical education
- In concert with Field medical lead/ Medical Director ensure local engagement planning process
- Support insight generation and use of insights generated to drive local strategy
- Development and implementation of TA data generation plan, incl. local data gap analysis for TA
- Oversees management of research grants (incl. investigator-initiated studies) for TA
- Management of country TA Medical budget
- Compliance of Medical deliverables for TA with local laws, regulations & codes, and company processes
- Registered signatory for country promotional and medical materials
- Ensures broader Medical team is adequately trained and TA specific trainings are in place
- Tasks
- Develop and maintain up to date scientific and medical knowledge and expertise (TAs and products)
- Bring health care / clinical practice expertise, therapeutic area knowledge, medical insights to cross-functional TA team to guide strategic and operational planning
- Ensure close and regular collaboration with TA brand leads and market access to shape the brand strategy and support the local / regional access plans/submissions
- Develop and implement all aspects of annual TA medical plan aligned with TA strategy
- Share local Medical insights, and align local Medical planning and execution with HQ Medical teams
- Deploy TA Medical budget according to strategy
- Identify, develop and maintain effective engagement with external medical experts and professional organisations
- Be deeply involved in access strategy development and implementation to assure access
- Develop a local evidence generation plan for TA and ensure compliant implementation of data generation activities. Provide medical leadership to Investigator Initiated Studies (IIS)
- Ensure compliant implementation of medical communication plan, e.g. disease awareness, medical education, and country congress activities
- Ensure and contribute to compliant implementation of local publication plans, including local congresses and manuscripts
- Analyse and utilize activities of and insight from field based medical team through the CRM
- Deliver medical training to field based medical team
- Timely respond to medical enquiries escalated by local medical information staff
- Approval of Local Key Information Documents (LKID) used by medical information to respond to medical enquiries
- Ensure compliance with applicable local and global laws, regulations, guidelines and company policies and procedures in all TA Medical Affairs activities
- Review and approval of local materials and HCP engagements- actively discusses with above country stakeholders on potential compliance issues and ensures materials are fit for use
Minimum Requirements
- Medical Education (MD) or Pharmacy Degree (PharmD), PhD in Life Science Field (e.g. Biology/ Biochemistry)
- 4 years’ experience with pharma industry in Medical Affairs and/ or Clinical Development or Safety at affiliate level
- Experience with local health care compliance topics
- Proven relationship building skills with internal and external stakeholders
- Working knowledge of commercialization and business practices as well as budgeting experience
- Basic understanding of Pharmacovigilance and Quality Management
- Excellent oral and written communication skills in <<local language (if more than 1 local languages: fluent in 1, advanced/ working knowledge in the other(s) >> and very good oral and written communication skills in English
Preferred Requirements
- Medical Education (MD)
- Medical specialization and/ or clinical / research experience in Internal Medicine, Nephrology or Cardiology
- 6 years’ experience with pharma industry in Medical Affairs and/ or Clinical Development at affiliate level and regional or global headquarters
- Experience with non-interventional study management and conduct
- Publication track record
- Fluent in local language(s) and English (verbal and writing)