What are the responsibilities and job description for the Senior Technical Writer position at Gandiv Insights LLC?
Hiring: Technical Writer
Location: San Rafael, CA (Onsite)
Duration: 6 months
Eligibility: GC/USC only
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.
- Arjun@gandivainsights.com
