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 Provide strategic direction for medical writing projects as the lead, including developing submission-level key messages and project lexicons. Serve as the main client contact for various document types. Organize and manage content, timelines, and resources proactively. Coordinate activities, review, and edit contributions from cross-functional teams. Mentor junior writers and develop team skills. Coordinate internal stakeholder input and resources like quality control and publishing. Ensure efficient document production using client document management systems and tools. Lead kickoff and roundtable meetings for drafts, vet comments, and ensure smooth review processes. Maintain consistency in messaging, formatting, and presentation across client programs. Perform peer QC reviews as needed. Contribute to operational initiatives like templates, style guides, and reference management. Requirements 10+ years of experience as a medical writer in CRO, biotech, or pharmaceutical fields, or equivalent. Advanced degree preferred. Oncology experience is a plus. Experience as a lead writer for key documents and managing major submissions. Familiarity with ICH, US, EMA, and other regulatory requirements. Proficiency with Microsoft Word and other MS applications. Experience with document management systems. Ability to work independently and collaboratively under pressure. Service-oriented with proactive project management skills. 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 careers@synterex.com . Beware of phishing scams—only trust contacts from synterex.com or our HR system BambooHR. #J-18808-Ljbffr Synterex

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