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Join to apply for the Principal Medical Writer role at Vor Bio Get AI-powered advice on this job and more exclusive features. Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies. The Principal Medical Writer collaborates on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs). This is an individual contributor position, equivalent to the Associate Director , without direct report responsibilities. Key Responsibilities Produce high-quality and on-time clinical documents Independently plan, coordinate, develop, update, and revise key documents, including clinical protocols, investigator brochures, clinical study reports, integrated efficacy and safety summaries, and related documents Independently lead supplemental filings, Type 2 Variations, rest-of-world filings, and clinical responses to questions Provide medical writing subject matter expertise and leadership to project teams and ensure proper planning and resourcing for upcoming project team writing deliverables Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, Medical Affairs, as well as with external stakeholders Contribute to the development and standardization of templates and related processes to support the medical writing needs of a growing organization and assist in training staff and contractors on MW processes Provide medical writing subject matter expertise and oversight for post-approval regulatory documents, such as PASS and other non-interventional protocols Qualifications Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred 7+ years of experience as a medical writer in the sponsor/CRO setting. Experience with regulatory submissions (NDA/BLA/MAA) strongly preferred. CTA/IND experience is a plus Some experience with developing MW processes and standards preferred In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process Successful track record of managing multiple projects in a fast-paced and deadline-driven environment Knowledge of eCTD formatting and EDMS systems preferred Experience overseeing the work of contract writers Impeccable attention to detail Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at for more information. Seniority level : Director (Note: this listing notes an individual contributor role equivalent to Associate Director) Employment type : Full-time Job function : Marketing, Public Relations, and Writing/Editing Referrals increase your chances of interviewing at Vor Bio by 2x Get notified about new Medical Writer jobs in Boston, MA . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Vor Bio

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