2 days ago Be among the first 25 applicants
Direct message the job poster from The Lotus Group LLC
Compensation: Total package in the high $500s (base + bonus + equity)
A highly stable and scientifically innovative biotech company is seeking a Senior Director of Medical Writing to lead its growing medical writing function. This is a pivotal leadership role responsible for overseeing both strategic and operational medical writing activities across the company’s clinical development programs.
Key Responsibilities:
* Lead and manage a team of direct reports including medical writers and contractors, fostering development and collaboration.
* Own the strategic planning, execution, and delivery of clinical and regulatory documents (e.g., protocols, CSRs, IBs, briefing books, submission dossiers).
* Serve as a key cross-functional partner to Clinical, Regulatory, Biometrics, and Program Management.
* Oversee document timelines, quality, and compliance with global regulatory standards.
* Represent Medical Writing leadership in cross-functional forums and regulatory meetings as needed.
* Build and scale infrastructure, processes, and documentation standards to support late-stage development and regulatory submissions.
Qualifications:
* Advanced degree in life sciences (PhD, PharmD, or MD preferred).
* 12+ years of relevant experience in medical writing within biotech or pharmaceutical companies, with at least 5 years in a leadership role.
* Proven success leading global submissions (NDA/BLA/MAA).
* Exceptional team leadership, mentorship, and organizational skills.
* Ability to work on-site in Boston on a hybrid schedule.
Seniority level
* Seniority level
Executive
Employment type
* Employment type
Full-time
Job function
* Job function
Science and Management
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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