Technical Writer Job

Technical CMC Writer - DACH - Remote

I am working with one of my key clients who are looking for a highly skilled technical CMC writer to support a high-impact regulatory submissions project.

This role is focused on authoring and integrating technical documentation into global regulatory dossiers, with a strong emphasis on drug substance and drug product modules (particularly Module 3 – P section).

Requirements: - Proven experience as a Technical Writer in a CMC context, in the pharmaceutical or biotech industry. - Author and compile technical documentation for regulatory submissions, including: Risk assessments, Control strategies, Process descriptions - Strong understanding of drug substance and drug product development and documentation. - Familiarity with global regulatory frameworks (EMA, FDA, ICH). - Experience with Module 3 of the CTD, particularly the P section. - Ability to work independently and manage multiple priorities in a dynamic project environment.

Contract: - Start Date: January 2026 - Length: 6/12 months - Hours: 20 to 40 hours per week - Location: DACH - Remote

If this is somethings that interests you, please send your CV to kyle.hansen@epmscientific.com

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