Remote Regulatory Writing Associate Director

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Mon, Jul 12, 2021

This job expires in: 7 days

Job Category: Writing

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Masters

Job Summary

A pharmaceuticals company is seeking a Remote Regulatory Writing Associate Director.

Must be able to:

  • Lead writing team for complex submissions
  • Ensure compliance of documentation to internal company standards and external regulatory guidelines
  • Author, review and/or independently handle high quality clinical and safety documents

Must meet the following requirements for consideration:

  • Minimum university life science degree or equivalent is required
  • ≥ 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge
  • Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements)
  • Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs
  • Expert knowledge of biostatistics principles

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