Gandiv Insights LLC
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.
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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