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Remote Technical Medical Writer (CMC)

Company: Pharmica Consulting
Location: Princeton
Posted on: June 13, 2021

Job Description:

Job Description:

The Technical Medical Writer (CMC) is a writing-based position within our Global Regulatory Affairs department. He/she will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation (Module 2 and Module 3).

  • Proactively manages writing activities across assigned projects as appropriate, ensuring adherence to the technical writing strategy and alignment with regulatory/Health Authority requirements.
  • Contributes to therapeutic project teams as the technical writing expert for CMC regulatory submission documents.
  • Adheres to writing practices/systems/tools to support CMC documentation in order to meet company goals and objectives.
  • Assures that standardized practices are implemented and maintained across all therapeutic areas.
  • Ensures writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations.

Required:

  • Minimum of a BA/BS in Life Science; graduate degree preferred
  • 4-7 years pharmaceutical/biotechnology experience related to analytical/pharmaceutical chemistry and/or regulatory affairs.
  • Demonstrated expertise in writing/developing CMC documents (Module 2 and Module 3) in support of global regulatory submissions
  • Experience in submitting and supporting Canadian and European regulatory filings preferred.
  • Experience with ICH and electronic submission guidelines for regulatory reports.
  • Excellent written and verbal skills
  • Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
  • Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies preferred
  • Ability to function in an ambiguous environment

Posted On: Wednesday, March 3, 2021

Keywords: Pharmica Consulting, Trenton , Remote Technical Medical Writer (CMC), Other , Princeton, New Jersey

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