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.
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.
Review and approve the team outputs including regulatory documents / scientific communication / clinical research related documents.
Assure Quality Oversight & Regulatory Compliance.
Oversee literature review methodologies, literature database management practices, and interpretation of scientific evidence.
Build and manage internal partnerships with PACE, Clinical Operations, Regulatory Affairs, Quality System and Marketing R&D and Engineering.

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

Senior Manager, Medical Writing

Key skills