Medical Info Specialist

Published
February 5, 2018
Job Type
Education Required
Solid scientific background, Ph.D., M.D., PharmD, MS or equivalent professional experience.

Description

Requisition No.: 22530-1

Status: Full Time

Project Duration: 6 months

Position Description:

  • Provide TA and US leadership for Mature Products in various Therapeutic Areas.
    ensure maintenance of Mature Products portfolio
  • Provide strategic regulatory input and prepare content for regulatory strategic documentation, eg response to FDA information requests
  • In partnership with labeling lead facilitate identification of and internal agreement on US labeling and supportive strategy for labeling issues.
  • Lead coordination and preparation for FDA interactions (written, teleconference, F2F meeting).
  • Build a strong and trusted relationship with the FDA project manager.
  • Act as a key contributor for the preparation of responses to queries from FDA and review content.
  • Drive the US FDA submission of all asset related documents such as IND/NDA annual reports.
  • Work with vendor to ensure that regulatory submissions are done in a timely manner

Skills Required

• Understanding of scientific content and complexities.
• Solid knowledge of US regulations, laws, and guidelines. US Regulatory experience a required.
• Good interpersonal skills; willingness to leverage strengths of the team, coordinate with outsourcing partner and peers within Mature Products Strategy and in a cross-functional environment.
• Ability to communicate issues and risks clearly in written and verbal format to teams and management.

Experience Required

3-5 years of experience in the pharmaceutical industry.
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