Associate Director Medical Writing Regulatory Writing
Overview
Own medical writing for clinical and regulatory submissions at Talent Groups, a Boston-based staffing firm. You will independently author complex documents and coordinate clinical sections of MAAs. Lead the Medical Writing Science team and provide strategic guidance across programs. This 2-month contract offers full relocation and potential to extend.
What You'll Do6
- 1Lead medical writing for clinical and regulatory submissions, including IND, NDA, and MAA documents.
- 2Author complex clinical and regulatory documents such as CSR, IB, and protocols with minimal supervision.
- 3Coordinate clinical sections of global regulatory filings, ensuring integration across CTD modules.
- 4Provide strategic guidance to cross-functional teams on medical writing best practices and regulatory requirements.
- 5Manage Medical Writing Science team activities, including resource allocation, training, and performance review.
- 6Drive process improvements and implement document management tools to increase efficiency.
Requirements7
- 18+ years in medical writing within pharma, biotech, or CRO, with regulatory writing experience.
- 24+ years leading or managing a medical writing team.
- 3Proven track record authoring IND, NDA, and MAA submissions.
- 4Bachelor's degree in life sciences; advanced degree (MS, PhD, PharmD) preferred.
- 5Experience in oncology, immunology, or rare diseases is a plus.
- 6Strong knowledge of ICH guidelines and CTD format.
- 7Excellent written and verbal communication skills.
Salary Insight
$95k per year
Location
Required Skills
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