Department: Azzur Solutions, LLC
Works cross-functionally with Global and European counterparts in Marketing, Market Access, Value Evidence, Clinical Development and others to create and execute global Strategic Asset Plans for each global and European products. Coordinates the strategic generation of scientific data and the consistent and accurate scientific communication about client's products globally. Maximizes the partnership between global and regional European medical teams through the combined team reporting structure.
- Oversees global medical affairs planning and activities in cross-functional collaboration with other global and regional functions.
- Responsible for annual data gap analysis to develop and evolve the product data generation plan for each global asset through its lifecycle.
- Responsible for the global evidence generation review process to harmonize the global Phase IIIB and IV programs, including Investigator Sponsored Studies and non-interventional studies
- Ensures that clinical trials include outcomes of interest to patients and fulfilling the medical needs in the therapeutic area.
- In collaboration with the Head of Global Medical Operations and Communications she/he will help create and execute the Global Publication Plans for each global and regional asset.
- Acts as a driving force in the public dissemination of product related data. Ensures that regional offices (OPEL and OIAA) and local affiliates are properly cognizant of all product related data and organizes coordination of medical activities across all regions.
- Oversees development of manuscripts, presentations, international symposia, and posters.
- Interacts with experts in the field to obtain feedback on clinical aspects of global products and new data generation, interpretation and dissemination
- Provides input into regulatory documents, including product labeling
- Participates in the evaluation of potential in-licensing candidates
- Establishes SOPs and sets standards to ensure that the medical function operates effectively and efficiently and that all medical communications are accurate and of high quality.
- Ensures compliance with all relevant Corporate Policies (CO) and Standard Operating Procedures (SOPs).
- MD, PhD or PharmD with exceptional leadership experience in the Medical Affairs area
- Minimum of 10 years of experience in Medical Affairs with at least 5 years of global responsibilities
- At least 5 years of demonstrated supervisory experience with the ability to lead and motivate others globally
- Requires extensive understanding of the company's products, clinical development, commercialization strategy, the competition, and the pharmaceutical industry in general.
- Solid statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately.
- Skilled in managing and influencing people in varying cultural settings
- Excellent communication and interpersonal skills
- Ability to travel up to 30% of time