Country Medical Director

2 meses atrás


Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro

**Country Medical Director Position at Biom?Rieux Bv**

Biom?Rieux Bv is seeking a Country Medical Director to serve as the primary country-level contact for the local medical organization. This role reports into the Regional Medical Directors/Heads and oversees Field Medical and Medical Services teams.

Key Responsibilities:
  • Country Medical team focusing on local Organon Medical strategy, with a heavy emphasis to help develop Global Medical strategy.
  • Supporting strategic planning and medical support of Company objectives.
  • Strategic planning and support of structured and consistent Continuous Medical Education (CME) activities.
  • Building close relationships with local Regulatory Agency.
  • Providing input into local study feasibility and sites selection and implementing publication policy.
  • Providing medical and scientific advice to business units, Market Access functions and others, as required, including input into Health Economics.
  • Serving as a member of the local leadership team.
  • Managing the country-developed Protocol Concept Sheets (PCS) and obtaining regional and global approvals for new local studies.
  • Reviewing and approving local study protocols and Investigator-Initiated Studies Programs (IISPs).
  • Advising business units on medical and scientific matters, including but not limited to scientific approval of promotional materials.
  • Ensuring compliance with all applicable country regulations and developing relationships with regulatory authorities in collaboration with the local head of regulatory.
  • Overseeing inspections and answering inquiries by health authorities and ethical committees in conjunction with Regulatory and Pharmacovigilance (PV).
  • Enhancing the company reputation and profile through an external focus by representing the company on cross-company boards and industry associations, including Company representations in mass media (in collaboration with PR Manager).
  • Orchestrating regional input for medical priority setting and co-sponsoring the regional Medical Affairs planning team to have bi-directional communication with Headquarters.
Requirements:
  • MD, Pharm D or PhD required.
  • At least 5 years of experience in global biopharmaceutical industry in Clinical Development and/or Medical Affairs.
  • At least 3 years of people management experience, running an organization of healthcare professionals.
  • Demonstrated effective organizational skills, including ability to set goals and align priorities.
  • Experience in one of the following fields: Women's Health, Biosimilars Immunology/Oncology, Fertility.
Preferred Qualifications:
  • Ability to communicate in English.
  • Strong understanding of the compliance environment in which Medical Affairs functions.
  • Business acumen, ethics and credible reputation with the external scientific community.
  • Experience in the development or field management of interventional/non-interventional clinical studies


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