Senior Manager, Medical Writing
Cogent BiosciencesWant to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
The Role: We are seeking an experienced, collaborative, detail-oriented medical writer with a passion for medical writing. The successful candidate will lead the planning, authoring, reviewing, and QC of clinical and regulatory documents. The individual will work with cross-functional SMEs as well as independently to develop high-quality, scientifically accurate documents. In this role, the successful candidate will collaborate with and may oversee the work of contract writers. In addition, the candidate will contribute to medical writing process development.
Responsibilities
- Employ scientific knowledge and analytical skills to author high-quality, scientifically accurate clinical and regulatory documents which may include clinical study protocols and amendments, clinical study reports, Investigator’s brochures, common technical document modules, and briefing books
- Facilitate document reviews and lead round-table meetings to achieve consensus among stakeholders on document content and strategy
- Ensure consistent messaging across documents as appropriate
- Represent the Medical Writing department on clinical study teams
- Perform and/or manage quality control reviews of clinical and regulatory documents as needed
- Collaborate with and manage contract writers as needed
- Contribute to the development and implementation of medical writing processes
- Adhere to regulatory standards and company SOPs
- Perform other medical writing related duties as assigned
Qualifications
- Bachelor’s degree
- Manager: 5+ years of medical writing experience; Sr. Manager: 7+ years of medical writing experience, or with fewer years of experience for individuals with an advanced degree [MS, PhD, MD, PharmD]
- Strong knowledge of FDA and ICH guidelines, GCP, and applicable regulatory processes related to document preparation
- Proficient in researching and understanding scientific literature and distilling complex topics clearly and accurately
- Proficient in interpreting and critically analyzing data and summarizing it clearly and accurately
- Strong project management and time management skills
- Excellent interpersonal, written, and verbal communication skills
- Self-motivated and effective in working with cross-functional teams
- Strong computer and software skills (Word, Excel, PowerPoint, Adobe suite, Veeva RIM, SharePoint) and ability to learn new computer applications
- Experience as a key contributor or lead author for submissions of regulatory documents is preferred