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Associate Director, Global Drug Safety & Pharmacovigilance Scientist

Company: Beacon Hill Staffing Group
Location: Princeton
Posted on: January 15, 2022

Job Description:

Overall responsibility for developing the analytical strategy from pre-clinical development through commercialDirect the writing and reviewing documents for INDs and other regulatory section submissions; represent the company as the CMC expert.Responsible for authoring CMC documentation, interpreting data concerning the API (active pharmaceutical ingredient) of drugs.Prepare, review, or edit cGMP batch records, CMC regulatory, and Quality documents.

  • Prepare standard documentation supporting regulatory filings and distribution to stakeholders.
  • Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
  • Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.
  • Draft, edit, and distribute various documents as needed based on templates and work instructions.
  • Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc.
  • Track regulatory activity, maintain and update databases, and ensure that records are complete and current.
  • Provide other administrative regulatory support as needed.

Keywords: Beacon Hill Staffing Group, Trenton , Associate Director, Global Drug Safety & Pharmacovigilance Scientist, Executive , Princeton, New Jersey

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