Job Description

Principal Medical Writer – Hybrid (Cambridge, MA)

On-site presence required at least 2 days per week. Remote applicants will not be considered.

The Principal Medical Writer plays a critical role on cross-functional teams, leading the development of clinical documents in compliance with relevant regulations, Good Clinical Practices, and internal Standard Operating Procedures (SOPs). This is an individual contributor role at an Associate Director level without direct reports, and includes oversight of internal and external writers.

Key Responsibilities

• Deliver high-quality, timely clinical and regulatory documents.
• Independently plan, develop, revise, and manage documents including protocols, investigator brochures, clinical study reports, and integrated summaries.
• Lead supplemental filings, Type 2 Variations, global regulatory submissions, and clinical response documents.
• Serve as a subject matter expert for medical writing and contribute to planning and resource allocation for deliverables.
• Manage document review and approval processes, including work from contractors and vendors.
• Collaborate with teams across Biometrics, Clinical Operations, Clinical Development, Program Management, Medical Affairs, Quality, and others.
• Contribute to template standardization and process improvements; support training for staff and contractors.
• Provide expertise and oversight for post-approval regulatory documents, including non-interventional protocols.
• Assist with mentoring and development of junior writing staff.

Qualifications

• Bachelor’s degree in Life Sciences or related field with strong writing background, or in English/Communications with relevant scientific expertise. Advanced degree or certifications preferred.
• Minimum 7 years of experience as a medical writer in a pharmaceutical, biotech, or CRO setting.
• Strong experience with regulatory submissions (NDA, BLA, MAA); CTA/IND experience a plus.
• Familiarity with developing writing processes and standards is preferred.
• Thorough knowledge of GCP, FDA regulations, ICH guidelines, and drug development lifecycle.
• Proven ability to manage multiple high-priority projects in a fast-paced environment.
• Experience with eCTD formatting and electronic document management systems (EDMS) is preferred.
• Experience in managing external writers.
• Excellent attention to detail.
• Proficient in Microsoft Word, Excel, PowerPoint, and Windows environment.

About the Company

This clinical-stage biopharmaceutical company has secured multiple global regulatory approvals and continues to expand its robust pipeline of investigational therapies. With a strong focus on high-impact areas such as rare diseases, oncology, cardiology, and metabolic disorders, the organization is committed to addressing significant unmet medical needs. Known for its scientific rigor and collaborative culture, the company is advancing a portfolio of innovative treatments aimed at improving patient outcomes worldwide.

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