Position Details
About this role
This role involves creating and managing clinical and regulatory documents for biotech and pharmaceutical products, ensuring compliance with industry standards and supporting product development.
Key Responsibilities
- Develop clinical/regulatory documents
- Ensure compliance with standards
- Collaborate with cross-functional teams
- Manage document timelines
- Support regulatory submissions
Technical Overview
The position requires expertise in technical writing for clinical and regulatory documents, with knowledge of GxP, ISO standards, and regulatory guidelines in biotech/pharma industries.
Ideal Candidate
The ideal candidate is an experienced scientific technical writer with at least 8 years in biotech or pharmaceutical industries, proficient in developing regulatory and clinical documents, and familiar with compliance standards like GxP and ISO.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience in biotech/pharma technical writing, No familiarity with regulatory standards (GxP, ISO, CLIA), Inability to work remotely
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