Remote Technical Medical Writer (CMC)
Company: Pharmica Consulting
Posted on: June 13, 2021
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
- 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.
- Minimum of a BA/BS in Life Science; graduate degree
- 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
- Experience in submitting and supporting Canadian and European
regulatory filings preferred.
- Experience with ICH and electronic submission guidelines for
- 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
- Excellent computer skills including MS Office (Word, Excel,
Power Point, Outlook); experience with electronic document
management systems and other content authoring technologies
- 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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