Principal Medical Writer

Synterex; Boston (MA); Hybrid; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Principal Medical Writer to join their dynamic team. In this pivotal role, you will lead the development of high-quality clinical and regulatory documents, collaborating with various client teams to ensure compliance and clarity. With a focus on strategic direction and mentorship, you will play a crucial role in enhancing the capabilities of the medical writing team. This opportunity offers the flexibility of remote work while also allowing for on-site client interactions as needed. If you have a passion for medical writing and a strong background in regulatory requirements, this role is a perfect fit for you.

Qualifications

• 10+ years of experience in medical writing within CRO, biotech, or pharmaceutical fields.
• Experience managing major submissions and leading key documents.

Responsibilities

• Lead medical writing projects, ensuring high-quality documents under tight timelines.
• Mentor junior writers and manage cross-functional team contributions.

Skills

Medical Writing

Project Management

Regulatory Compliance

Oncology Experience

Strong Communication Skills

Education

Advanced Degree

Tools

Microsoft Word

Document Management Systems

Job description

Join to apply for the Principal Medical Writer role at Synterex.

Synterex, Inc. is a global consortium of experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. The company offers remote or on-site services, focusing on clear, concise, accurate, and compliant documentation from early drug development through post-approval.

We are seeking an organized, motivated, and collaborative individual for our medical writing team. The principal medical writer will partner with client teams across Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality clinical and regulatory documents, including protocols, publications, study reports, investigator brochures, narratives, and module documents, adhering to client and agency guidelines under tight timelines.

Location

Fully remote position, with preferred ability to attend on-site meetings with clients as requested.

Essential Duties & Responsibilities

1. Provide strategic direction for medical writing projects as the lead, including developing submission-level key messages and project lexicons.
2. Serve as the main client contact for various document types.
3. Organize and manage content, timelines, and resources proactively.
4. Coordinate activities, review, and edit contributions from cross-functional teams.
5. Mentor junior writers and develop team skills.
6. Coordinate internal stakeholder input and resources like quality control and publishing.
7. Ensure efficient document production using client document management systems and tools.
8. Lead kickoff and roundtable meetings for drafts, vet comments, and ensure smooth review processes.
9. Maintain consistency in messaging, formatting, and presentation across client programs.
10. Perform peer QC reviews as needed.
11. Contribute to operational initiatives like templates, style guides, and reference management.

Requirements

1. 10+ years of experience as a medical writer in CRO, biotech, or pharmaceutical fields, or equivalent.
2. Advanced degree preferred.
3. Oncology experience is a plus.
4. Experience as a lead writer for key documents and managing major submissions.
5. Familiarity with ICH, US, EMA, and other regulatory requirements.
6. Proficiency with Microsoft Word and other MS applications.
7. Experience with document management systems.
8. Ability to work independently and collaboratively under pressure.
9. Service-oriented with proactive project management skills.
10. Strong communication and conflict management skills.

Synterex is an equal opportunity employer, committed to diversity and inclusion in the workplace. For more information or to apply, contact [e-mail]. Beware of phishing scams—only trust contacts from synterex.com or our HR system BambooHR.