Senior Technical Writer Job at Tucker Parker Smith Group (TPS Group) in San Rafa

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

Bachelor'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

Preferred (Nice to Have)

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

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