We are seeking an experienced Technical Writer to support authoring of CMC content for regulatory submissions. The ideal candidate will be skilled in creating clear, accurate, and submission-ready documentation for health authorities.
Responsibilities :
Author CMC content, initiate reviews, and manage comment adjudication / finalization.
Deliver high-quality, compliant dossiers for health authority submissions.
Collaborate with cross-functional SMEs to ensure scientific accuracy and regulatory alignment.
Requirements :
Strong technical writing background in CMC / Regulatory Affairs.
Excellent written and verbal communication skills.
Ability to interpret and present complex scientific information clearly.
Seniority level Mid-Senior level
Employment type Contract
Job function Marketing, Public Relations, and Writing / Editing
Gandiv Insights LLC is an equal opportunities employer.
#J-18808-Ljbffr
Gandiv Insights LLC is hiring: Senior Technical Writer in San Rafael • San Rafael, CA, United States