The Principal Medical Writer represents medical writing on multi-disciplinary teams, collaborates on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs), and oversees the work of internal and contract writers. This is an individual contributor position, equivalent to the Associate Director, without direct report responsibilities.
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 collaborate with the Medical Writing line management to 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.
- Assist the line managers in the training and development of junior staff.
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.
- Demonstrate clear alignment with Alnylam Core Values including,
- Commitment to People
- Innovation and Discovery
- Purposeful Urgency
- Open Culture
- Passion for Excellence.
About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.
