Job Summary
Sr. Manager Medical Writing, manages and oversees the work of medical writing teams to support clinical and regulatory submissions (e.g., clinical evaluation reports, clinical study reports,) and product development. This role partners with Engineering and R&D, Clinical Affairs, Professional & Clinical Education, Regulatory Affairs, Quality Systems, Marketing, Sales as well as external stakeholders, to include FDA, NB, PMDA, KOL, HCP, IRB and publishers. The role reports directly to the Senior Medical Director, Scientific Data & Communications.
Job Details/Responsibilities
- Lead, mentor, and develop a team of medical writers responsible for clinical evaluation, scientific communication, and regulatory documentation. Oversee workload allocation, project prioritization, and timely delivery of high‑quality documents; and lead talent development in alignment with growth strategies of the department. 40% of role.
- Provide technical guidance, writing expertise, and scientific oversight to ensure consistency, accuracy, and compliance with applicable regulations and internal standards. Develop and maintain SOPs, work instructions, and best practices related to medical writing. Serve as subject‑matter expert in medical writing standards, expectations of regulatory bodies, and scientific communication. 20% of role.
- Review and approve the team outputs including regulatory documents / scientific communication / clinical research related documents. 20% of role.
- Assure Quality Oversight & Regulatory Compliance. Oversee literature review methodologies, literature database management practices, and interpretation of scientific evidence. 10% of role.
- Build and manage internal partnerships with PACE, Clinical Operations, Regulatory Affairs, Quality System and Marketing R&D and Engineering. 10% of role.
Working Conditions/Physical Requirements
- This position requires up to 10% of travel
- Manage a team of 3 direct reports
Knowledge, Skills and Abilities (KSA)
- Strong leadership in project and team management, including coaching and performance oversight.
- Excellent organizational and time management skills
- Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), with GCP, and ICH guidelines
- Ability to adapt to changing priorities
- Knowledge of biomedical statistics, clinical literature review
- Highly proficient in using Microsoft Office applications (Word, Excel, PowerPoint) and EndNote
- Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases
- Knowledge and understanding of PICO methodology
- Ability to function in a self-directed manner with a high degree of independence
- Strong verbal, written, and interpersonal communication skills
- Ability to persuasively influence external medical professionals
- Effective analytical and problem-solving skills
- Excellent interpersonal and effective leadership, verbal and written communication skills and effectively work across departments with diverse needs
Qualifications/ Background Experiences
- Advance Degree ((Ph.D., MD, Sc.D, MA/MS or MPH) in a medical/biomedical/scientific discipline with a minimum of 5 years of experience in medical writing of regulatory documentation (clinical research documentation is optional) OR Bachelor’s Degree, preferably in life sciences with 10 years of relevant work experience; OR equivalent combination of education, training and relevant experience.
- Demonstrated relevant track record in people management how many years?
- Experience in medical or scientific writing and creating content for scientific presentations
- Demonstrated experience in the development of regulatory/clinical submissions, preferably as a medical writer for pharmaceutical, CRO, or medical device clients, a strong plus.
- Experience with Class III devices and CER development under MDR preferred
