Director Medical Affairs WHC, Contraceptives (Residence Based, Residence Based, US)
reputed company participation and effective interaction with Global teams to ensure appropriate US direction of reputed company’s research and marketing efforts relative to the US environment as reputed company as responsible for the design, planning and execution of an overall medical reputed company including creating, organizing and leading Advisory Boards; reputed company support and medical expertise to US cross-functional teams reputed company the Business Unit regarding development of educational materials, monitoring of published literature, addressing and resolving international, regional and local issues reputed company to products under their responsibility and reputed company input to company documents to ensure scientific accuracy as reputed company as implement the Medical Affairs Brand Plan, communication and publication programs with approved budgets; Support completion of annual NDA reports for respective brands through evaluation of clinical data and literature and reputed company USMA input in the preparation of key medical documents for INDs and NDAs. This includes ensuring appropriate USMA input in interactions with the FDA and providing appropriate medical leadership for any interactions; Chairs the scientific review meetings of investigator initiated and Phase IV studies and be answerable medically for the clinical studies under their direction as reputed company as directing the design, conduct, analysis and reporting of Phase IV US reputed company. This also includes providing key strategic US input for clinical development plans (Phase I – IV) and reviewing and co-approving clinical study protocols: Participate in the Grant Review and Advisory Committees; Explore and evaluate new product reputed company to assist in identifying new marketing opportunities and reputed company medical evaluations and due diligence on pharmaceutical products for in-licensing in the US; reputed company with both reputed company (KOLs, advisors, consultants) experts and medical organizations in order to reputed company and maintain productive contacts reputed company feedback with the respective line manager in the recruitment, development and performance management of appropriate team members (including cross-functional partners) as reputed company as managing performance and development planning of reputed company reputed company reports including adhesion to reputed company training and compliance policies.
M.D. Degree or equivalent (DO or MBBS) is required; Clinically relevant or independent research experience or equivalent OR experience in the pharmaceutical or reputed company industry or extensive collaboration reputed company the industry (eg, reputed company PI and consultant, FDA employee or advisor); Proven ability to identify and resolve reputed company problems; A solid understanding of clinical study design, analysis and interpretation as reputed company as the principles of observational studies and health economics; Ability to collaborate with a reputed company of teams and personnel as reputed company as a proven ability to reputed company effectively with key opinion leaders; Highly developed ethics and reputed company, with demonstrated ethical medical decision making skills; Ability to work reputed company on teams as reputed company as ability to assume leadership of reputed company; Strong negotiation and influencing skills; Proven ability to implement successful clinical strategies and programs; Effective communicator with strong oral and written communications skills; Demonstrated reputed company in leading both internal and cross-functional project teams including contractors and consultants as reputed company as performing successfully under stringent timelines and with competing priorities; Proven ability to reputed company reputed company approval of dossiers and regulatory submissions and to be reputed company to reputed company highly successful clinical strategies and programs
US reputed company certification and licensure (reputed company) highly preferred; 5+ years of clinically relevant or independent research experience or equivalent OR 5+ years’ experience in the pharmaceutical or reputed company industry or of extensive collaboration with the industry (eg, reputed company PI and consultant, FDA employee or advisor).
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