Senior Manager, Medical Writing

• Employ scientific knowledge and analytical skills to author or oversee the authoring of 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 comment resolution meetings to achieve consensus among stakeholders on document content and strategy
• Coordinate, develop, and ensure consistent messaging across clinical program(s)
• 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 with 6+ years of Medical Writing experience, or advanced degree (eg, PhD, MD, PharmD) with fewer years of Medical Writing experience
• Self-motivated and effective in working with cross-functional teams
• 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
• Excellent interpersonal, written, and verbal communication skills
• Strong project management and time management skills
• Strong computer and software skills (eg, Word, Excel, PowerPoint, Adobe suite, Veeva RIM, SharePoint) and ability to learn new computer applications
• Strong knowledge of FDA and ICH guidelines, GCP, and applicable regulatory processes related to document preparation

Salary Range:

$170,000- $200,000 USD