Medical Expert
Gefunden in: Talent DE 2A C2 - vor 2 Wochen
Summary:
Join our client, a thriving company with over fifty years of continuous growth. As a Medical Doctor specialised in the clinical area, you'll contribute to the advancement of medical products and devices for oncological, urological, and autoimmune diseases. With over 2,000 dedicated employees, our client is a leading pharmaceutical company specializing in niche products.
Tasks:
- Evaluate and authorize MSC requests (NPU) from a clinical-medical perspective.
- Prepare clinical-medical documents for regulatory agencies (e.g., PEI).
- Develop essential documents for drug authority approval (clinical overview, summary, expert statements, risk management plans, package leaflets, CCDS, PSURs).
- Create and review documents within clinical development (IB, IMPD, PIP, DSUR).
- Conduct regular literature and convention reviews.
- Assess new drug opportunities from a clinical-scientific perspective.
- Respond to medical inquiries internally and externally.
- Provide clinical-medical expertise for regulatory purposes across all departments.
- Organize and contribute to advancements in managed access programs.
Requirements:
- University degree in human medicine (MD).
- Clinical pharmacology experience.
- Minimum of 3 years in clinical development within the pharmaceutical industry, preferably in haematology and autoimmune diseases.
- Strong regulatory writing skills for CTD documents.
- Team player with excellent communication and cooperation abilities.
- Proficient in English, good knowledge of German.
Benefits:
- Collaborate with a dynamic and dedicated team.
- Contribute to the development of cutting-edge medical products.
- Opportunities for professional growth and advancement.
- Engage in challenging and meaningful work within the pharmaceutical industry.
- Competitive compensation and benefits package.
- Foster international collaboration with proficiency in both English and German.
- Be part of a company with a rich history and continuous growth in the pharmaceutical sector.
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