Associate Director, Medical Writing - NDA/BLA & Regulatory Strategy
Job Description
Title: Associate Director, Medical Writing – NDA/BLA & Regulatory Strategy
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Location: Greater Boston Area, MA (Hybrid – 3 days onsite / 2 days remote)
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Employment Type: Contract
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Duration: 6 months, with possible extension or conversion
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Status: Accepting Candidates
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About the role
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Lead strategic Medical Writing Science activities supporting complex clinical and regulatory programs. This role provides leadership for document development, regulatory submissions, cross-functional alignment, and program-level writing strategy.
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Key Responsibilities
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- Independently author complex clinical and regulatory documents.
- Provide strategic writing input into program-level plans and initiatives.
- Coordinate clinical sections of complex regulatory submissions.
- Develop consistent information and messaging across clinical programs.
- Lead Medical Writing Science activities and manage direct reports.
- Anticipate risks, solve complex problems, and implement process improvements.
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Qualifications
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- 8+ years of relevant work experience with 2+ years of supervisory/management experience, or equivalent combination.
- Demonstrated experience with marketing authorization application regulatory submissions.
- Experience with NDA/BLA filings; briefing book experience is highly desirable.
- Proven strategic writing experience within clinical/regulatory programs.
- Bachelor's degree in a relevant discipline; Ph.D. or equivalent degree.
- Strong leadership, resource planning, problem-solving, and cross-functional collaboration skills.
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Compensation (MA Pay Transparency):
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- Estimated hourly range: $80–$95/hr (W-2).
- Final rate within this range will be based on skills, experience, and interview results.
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