Medical expert - Wheaton, United States - Horizon Innovations

Horizon Innovations
Horizon Innovations
Verified Company
Wheaton, United States

3 weeks ago

Meredith Sinclair

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Meredith Sinclair

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Description

Summary:

Join our client, a successful company with over fifty years of continuous growth, as a Medical Doctor specializing in the clinical field. You will play a crucial role in the development of medical products and devices for oncological, urological, and autoimmune diseases. With a team of over 2,000 dedicated employees, our client is a leading pharmaceutical company that specializes in niche products.

Responsibilities:

  • Evaluate and approve MSC requests (NPU) from a clinical and medical perspective.
  • Prepare clinical and medical documents for regulatory agencies (e.g. PEI).
  • Create essential documents for drug authority approval (clinical overview, summary, expert statements, risk management plans, package leaflets, CCDS, PSURs).
  • Develop and review documents for clinical development (IB, IMPD, PIP, DSUR).
  • Conduct regular reviews of literature and conventions.
  • Assess new drug opportunities from a clinical and scientific standpoint.
  • Respond to medical inquiries from both internal and external sources.
  • Provide clinical and medical expertise for regulatory purposes across all departments.
  • Organize and contribute to advancements in managed access programs.

Requirements:

  • University degree in human medicine (MD).
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