The Senior Medical Writer is a key individual responsible for writing, reviewing, and editing clinical documents. This is an individual contributor position with team leadership responsibilities. The senior medical writer will work closely with cross-functional teams to ensure the documents are high quality and completed in a timely fashion and in compliance with ICH/GCP/regulatory guidelines, SOPs, and company goals. This individual may also support other medical writing activities as requested.

Responsibilities

• Write, review, and edit clinical regulatory documents such as clinical study protocols,
• CSRs, Investigator’s Brochures, IND/NDA/BLA clinical summaries, and other documents as required for submissions
• Interpret statistical and clinical data with appropriate guidance/direction from teams and management
• Arrange and conduct review meetings with teams and independently resolve document content issues and questions arising from the writing/review process
• Work with cross-functional groups, including clinical research, biostatistics and drug safety, to set priorities for document preparation and collaborate on document content.
• Represent Medical Writing on project teams and advise on content and format requirements for various documents
• Develop timelines and communicate writing process and timelines to team members
• Interact with internal and external authors (as needed) and key stakeholders to develop high quality documents
• Provide status/updates of Medical Writing deliverables to management, and create/track timelines
• Contribute to document templates (e.g., protocols, CSRs) and style guides
• Comply with established company policies and procedures, and industry and regulatory guidelines
• May contribute content to safety documents (e.g., DSURs)
• Assist in the development of SOPs for Medical Writing processes
• Provide additional support to the Medical Writing team and the Clinical and Regulatory team as needed
• Other duties as assigned

Qualifications

• BA/BS in one of the life sciences with a minimum of 5 years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 4+ years of relevant medical writing experience
• Ability to work both independently and in cross-functional team environments with minimal supervision.
• Ability to work effectively in a fast-paced environment with multiple high-priority projects
• Project management skills
• Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP)
• Strong written and verbal communication skills. Ability to engage and disseminate information among appropriate stakeholders for effective document production.
• Attention to detail with an ability to detect errors and inconsistencies in various types of documents