CMC Technical Writer

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Job description

CMC Technical Medical Writer

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 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 (with primary interest in the areas of Biologic and Small Molecule drugs).

- 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