Senior Technical Writer
MediabistroWorkFromHome, CA, United Statesjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionBachelor's degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences; advanced degree preferred Extensive experience (e.g. 5-10+ years) in authoring regulatory CMC documentation for health authority submissions (CTD Module 3 etc.) Demonstrated ability to understand, interpret, and synthesize complex scientific / technical information Excellent written and verbal communication skills; high attention to detail Prior experience managing reviews, comment adjudication, finalization of documents Familiarity with regulatory standards, guidelines (US FDA, EMA, Health Canada etc.), dossier structure, submission process Ability to work in hybrid environment, collaborate with cross-functional teams Experience in biologics or gene therapy / combination products Experience with global submissions and variation management Prior experience at biotech / pharma environment Experience with document management systems, regulatory writing tools
Professional Recruiter | Matching Talent with Opportunity at TPS Group
Senior Technical Writer, Regulatory Affairs (CMC)
Location : Hybrid in San Rafael, CA
Department : Regulatory Affairs (CMC)
Duration : 6 months, with strong possibility to extend or convert to full time
Pay : $75-$90 / hour DOE
Key Duties & Responsibilities
- Lead authoring of CMC (Chemistry, Manufacturing & Controls) content for regulatory submissions (e.g., IND, BLA, MAA, variations)
- Initiate internal reviews, coordinate cross-functional input, manage and adjudicate comments & revisions, finalize documents to regulatory standard
- Ensure submission dossiers are regulatory authority ready : compliant, accurate, scientifically sound, well-structured, and clearly communicated
- Interpret complex scientific, manufacturing, analytical, and quality data in clear, precise written text
- Collaborate with SMEs (chemistry, manufacturing, analytical development, quality) to gather needed inputs, clarify technical content
- Maintain high quality of writing : excellent grammar, consistency, style, compliance with guidelines (eCTD, CTD, local regulations)
- Support tracking of document timelines; ensure deliverables met and escalate risks proactively
Required Skills & Qualifications
Preferred (Nice to Have)
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Senior Technical Writer • WorkFromHome, CA, United States