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The Fertility Head of Medical Affairs, EMEA is responsible for ensuring the company's Medical therapeutic area leadership within EMEA through appropriate Medical Affairs strategies and activities while maintaining compliant standards with all pharmaceutical regulations and laws takes the medical lead and medical responsibility of the assigned portfolio in the therapeutic franchise within Global Medical Affairs.
Provides medical expert advice to ensure proper development and the promotion of fertility portfolio. Develops medical educational materials and stays informed on scientific landscape and relevant clinical practice dynamics. Maintains relationships with target regional opinion leaders and trains local teams on medical topics.
KEY TASKS & RESPONSIBILITIES:
- Leads the Regional Medical Affairs TA team
- Provides expert consultation to affiliates and regional Medical Head on development of the affiliate Fertility therapeutic area strategy and brings insights and knowledge from the region to the Global GMA TA to inform GMA strategy
- Coordinates on a regional level the TA specific data generation activities and is first point of contact for data generation proposals from countries in region (RCO List), and advocates prioritized generation activities at GMDB level.
- Provides scientific and technical expertise on the generation of hypothesis to be tested, method and design of regional research, trial execution and communication. Oversees the conduct of regional clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analysis for clinical significance, investigator selection, safety monitoring, study reports, and other communications of study results.
- Provides scientific and technical consultation to affiliates in the development and method of evaluation of research hypotheses
- Serves as the representative of the region in providing input into the content of registrational studies and GMA data generation studies
- Educates on and coordinates appropriate scientific and medical activities with internal stakeholders (ie commercial, clin ops, discovery, statistics, regulatory, etc..) including training region and affiliate cross-functional peers on therapeutic area topics. On-boards affiliates and regional cross-functional partners to therapeutic area and product topics.
- Supports publication process and publication awareness in Region and ensures alignment across all countries
- Oversees scientific and medical education of investigators and clinical monitors for GMA studies in the region. May provide support to affiliate sponsored studies as needed.
- Develops and executes advisory boards and symposia aligned with regional/global strategy
- Identify Regional key stakeholders in TA
- Manages and conducts regional external expert engagement. Keeps abreast of professional information, science and technology through conferences and/or medical literature and acts as a therapeutic area resource
- Represents the company at external meetings including investigator meetings, scientific association meetings, etc. May serve as the scientific team representative for regulatory discussions
- May support affiliate ad boards and conducts regional ad boards, based on clear objectives and deliverables, resulting in summary report shared with GMA, and ensuring, budgets, timelines, compliance requirements are factored into program’s initiatives
- Collect and share best practices across Region TA
- Ensure compliance with global and local, external and internal regulations, standards, policies and SOPs
- Capture, record and forward any information regarding adverse reactions and /or Quality issues to the current responsible LDSO and/ or Quality officer
Who You Are:
- University Medical degree (Bachelor’s) required, preferably in scientific field of relevance to position
- Secondary / advanced scientific degree (e.g., MSc, PharmD, PhD, DO, MD) desirable
- Other advanced degree (non-scientific) desirable
- Training in local and international regulations including Good Clinical Practice
- Proven training/experience in Epidemiology, RWD, Clinical Pharmacology and/or Administration is advantageous
- Scientific and/or clinical training in fertility to position required
- Minimum Experience: 8-10 years in pharmaceutical industry (Clinical Development/ Medical Affairs/ Commercial Operations)
- Experiences in clinical practice as licensed specialist
- Prior industry experience as Medical Manager/ Director
- Knowledge and experience in project management
- Previous experience leading teams and/or mentoring new hires and working in teams required
- Ability to travel domestically and internationally as needed
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com