Medical Information Associate Director (gn) | remote (60% DACH, 40% EMEA)
Uniquely positioned to fundamentally change the lives of patients with 'forgotten' diseases, our client is at the forefront as a leading company with over 1000 employees worldwide, developing innovative therapeutic options that have a significant impact on these diseases.
The commitment ranges from established commercial products that have helped thousands of patients, to late-stage development programmes on the verge of widespread use, as well as ground-breaking early-stage research.
What will your activities as "Medical Information Director (gn)" involve??
Ensure compliance with § 8 Abs. 1 Nr. 2 AMG, including support in the creation and updating of SmPCs and mandatory texts
Oversee regular review and updates to listings in national medicinal product directories (e.g., Rote-/Gelbe Liste).
Continuously monitor relevant national legislation and ensure compliance
Ensure that all promotional material is in line with the marketing authorization of the medicinal product.
Coordinate local reviews of internal and external medical, promotional, and non-promotional content in collaboration with Marketing, Compliance, Medical Advisors, and Regulatory teams.
Act as the final approver for local commercial and medical reviews
Serve as the interface between marketing and science to ensure accurate and compliant communication of regulatory and medical content.
Provide regulatory consultation in the development of national and international marketing strategies.
What qualifications should you have as a "Medical Information Director (gn)"?
Thorough understanding of EU regulations, compliance and industry standards relating to communicating product information to HCPs and/or consumers
Proficiency in medical writing, able to correctly understand, correctly interpret, and accurately communicate scientific data and statistical analyses
An advance degree is required (e.g. PharmD, MD, PhD)
Every day, work is carried out here to push the boundaries of medicine and improve people's lives in the long term. Become part of a team that is committed to creating a world in which no disease is forgotten. Apply to me now!
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