Supports Global Medical Director to define medical affairs strategy and medical activities related to GI&H TA.
Core Job Responsibilities:
Supports and conducts following responsibilities under supervision of Global Medical Director
Provides scientific / medical liaison to internal stakeholders.
Drives and generates innovative medical ideas regarding potential new development opportunities in the respective therapeutic area based on key insights and perspectives from multiple stakeholders.
Identifies suitable mid-and long-term differentiating opportunities with a potential of meeting unmet current medical needs.
Continuous medical evaluation of products under scope of responsibility, identifying potential substances to fill gaps in portfolio (including in-licensing opportunities to fully address patients’ needs based on latest scientific knowledge)
Provides sound and up-to-dated medical information, disease knowledge and medical training to stakeholders such as e.g. I&D departments, Public Affairs, Marketing/Commercial departments, affiliate (medical) teams
Prepares therapeutic area target product profiles (TPP) with a cross-functional team.
Drives medical scientific knowledge, evaluates, and reviews medical literature, generates potential new differentiated ideas (incl. digital) to enhance and maximize potential benefit for disease management and patient care.
Drives TA medical plans, incorporating therapeutic area strategy, areas of research interests, publication planning, tactical plans, study initiatives.
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Responsible for global medical affairs research projects, and reviews and jointly approves all medical research activities that are primarily led by the medical affairs as a member of the scientific review and approval board.
Secures and maintains good collaboration with the regional and local medical directors for alignment of local activities with the global brand strategies.
Drives & oversees establishment and maintenance of scientific collaborative relationships with Key Opinion Leaders (KOLs), accountable and responsible for KOL development, including approaching KOLs for provision of services.
Oversees TA medical content generation for digital activities intended for patients and HCPs.
Under supervision of Global Medical Director supports internal cross-functional teams (brand teams, project teams, product safety team, labeling sub-team):
Provides scientific liaison to these teams with accurate and up to date scientific knowledge. Ascertains a proper alignment of medical, I&D and marketing activities.
Initiates and leads medical affairs activities, generates, and disseminates scientific data supporting overall product scientific and business strategy.
As a member of the Product Safety Team: Leads safety monitoring within all clinical activities under his/her responsibility (global medical affairs or affiliate sponsored clinical activities), oversees the medical review or development of white papers, certain sections for addenda to clinical overviews, PSURs and dossiers, approves risk management plans
Provides medical evaluation and propose scientific strategies with regards to major national label change requests (including safety issues as requests for DDLs), with team responsible for global company scientific information (CCDS, Master SmPC)¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
Develops and maintains proper and up to date product and disease state trainings.
Oversees medical expert opinion for regulatory and safety documents, and medical assessments for QA related internal requests related to the products under responsibility.
Supports the process of product-specific medical queries from the Health Authorities, Health care Professionals, affiliates, patients and field force, etc.
Safeguards that marketing activities are done in compliance with the appropriate guidelines and regulations. Participate in the process of approval of promotional material and maintain proper use of scientific data in global communications relating to assigned brands.
Supervisory/Management Responsibilities:
Direct Reports: - none
Indirect Reports: - none
Minimum Education:
M.D.(preferred) with minimum 5 years’ experience in the relevant field of the pharmaceutical industry.
An advanced degree in life sciences: i.e. M.Sc, with a minimum of 7 years’ experience in the relevant field of the pharmaceutical industry, Pharm D / PhD with a minimum of 5 years’ experience in the relevant field of the pharmaceutical industry.
Minimum Experience/Training Required:
Good understanding and experience in conduct of clinical trials or in medical research in the pharmaceutical industry or academia or equivalent.
Knowledge of clinical / medical trial methodology, oversight/evaluation of safety and regulatory requirements governing clinical / medical trials.
Strong experience in KOL management and scientific society relations are required.
Strong understanding of compliance requirements and being able to operate effectively within the constraints of an increasingly compliance-driven environment to safeguard public trust and company reputation
English proficiency (oral and written), other languages considered an advantage.
Prior experience in country/regional medical role is desirable.
Strong written and verbal communication skills.
Strong presentation skills.
Strong business acumen in pharmaceutical industry
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