Posted: 18 June
The role
Turn science into submission-ready success-lead medical writing in a fast-paced biotech setting.
Proclinical is seeking a Senior Manager, Medical Writing to join a dynamic team in the rare disease and biotechnology space. In this role, you will collaborate with cross-functional project teams to develop high-quality clinical documents while ensuring compliance with applicable regulations and standards. This hybrid position requires two days per week in the office.
Responsibilities:
Produce high-quality, timely writing deliverables, including clinical protocols, investigator brochures, clinical study reports, and related documents.Independently plan, write, edit, and format key clinical documents.Manage and facilitate the review and finalization process for documents created internally or by external consultants, contractors, and vendors.Represent Medical Writing on early-phase or specific late-phase project teams, collaborating with leadership to ensure proper planning and resourcing for deliverables.Collaborate effectively with internal teams such as Biometrics, Clinical Operations, Regulatory Affairs, and others, as well as external stakeholders.Serve as a subject matter expert for clinical document production.Contribute to the development and maintenance of SOPs and templates.Key Skills and Requirements:
Bachelor's degree in Life Sciences with relevant writing expertise or in English/Communications with relevant science expertise; advanced degrees or certifications are a plus.Proven experience as a medical writer, ideally with exposure to regulatory submissions (e.g., CTA, IND, NDA, BLA) and knowledge of eCTD formatting.Strong understanding of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.Demonstrated ability to manage multiple projects in a fast-paced, deadline-driven environment.Exceptional attention to detail and ability to deliver high-quality work on time.Experience overseeing contract writers is advantageous.Proficiency in Microsoft Word, Excel, and PowerPoint.Willingness to travel approximately 10%.
