Senior Director, MW - Permanent - Cambridge, MA
Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.
探花合集 is seeking a Senior Director of Medical Writing to lead clinical and regulatory medical writing activities in support of clinical development programs, including Biologics License Application (BLA) filings. This role involves establishing and managing the medical writing function within a pre-commercial biotechnology organization, ensuring the delivery of high-quality regulatory documents that meet global submission requirements.
Primary Responsibilities:
The successful candidate will collaborate with cross-functional teams to develop strategies, oversee internal and external resources, and drive execution across clinical and regulatory programs. This position offers an opportunity to make a meaningful impact in oncology and biotechnology by contributing to innovative treatments for patients.
Skills & Requirements:
- Advanced degree (PhD, PharmD, MS) in life sciences, health sciences, or a related field.
- Proven experience in medical writing within the biotech-pharmaceutical industry, including leadership of BLA or NDA submissions.
- Strong understanding of global regulatory requirements, ICH guidelines, and industry standards.
- Oncology experience is preferred.
- Demonstrated ability to manage end-to-end authorship of regulatory documents for late-stage clinical development.
- Leadership experience in building and managing high-performing teams and external vendors.
- Excellent written and verbal communication skills with the ability to influence and collaborate cross-functionally.
The Senior Director, MW responsibilities will be:
- Build and lead the global medical writing function to support clinical development programs through LA submission and beyond.
- Develop and implement a strategic plan for medical writing activities aligned with clinical, regulatory, and business goals.
- Define and manage scalable medical writing processes, tools, and standards.
- Partner with cross-functional teams (Regulatory, Clinical Development, Biostatistics, etc.) to ensure submission readiness and alignment on documentation needs.
- Oversee the planning, authoring, review, and finalization of core regulatory submission documents, including:
- Clinical Study Reports (CSRs)
- Module 2 and Module 5 documents for BLA submissions
- Integrated Summary of Efficacy (ISE) and Safety (ISS)
- Risk Management Plans, diversity plans, pediatric plans, and briefing documents
- Annual reports, IND amendments, Investigator Brochures, and DSURs/PSURs/PBRERs
- Ensure compliance with ICH, FDA, and EMA guidelines in all regulatory documentation.
- Drive document strategy discussions, timelines, and workflows to meet submission deadlines.
- Establish quality control processes to maintain inspection readiness and document traceability.
- Lead lessons-learned efforts post-submission to improve documentation practices.
If you are having difficulty in applying or if you have any questions, please contact George Watson at g.watson@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - /privacy-policy
