We are seeking an experienced and motivated medical writer who is responsible for providing clinical and regulatory document support and advanced medical writing expertise to cross-functional teams, ensuring the successful and timely preparation of high-quality documents. This individual will also participate in the development and maintenance of document templates, style guides, and standard operating procedures to ensure consistency and quality across documents and will represent Medical Writing at various team meetings. This position reports to the Executive Director, Medical Writing and Regulatory Execution.

Key Responsibilities

• Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: protocols, investigator’s brochures, clinical study reports, briefing documents, Module 2 summary documents, and other clinical and regulatory documents.
• Communicates deliverables needed, writing process, and timelines to team members, and holds team members accountable to agreed-upon document milestones.
• Negotiates with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers and using creativity to ensure teams achieve document-related project goals
• Ensures compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing and communication.
• Maintains document templates, style guides, and best practices to ensure consistency and quality in written materials.
• Oversees the planning, coordination, and execution of medical writing projects by external vendors and consultants to ensure milestones are met and resources are allocated efficiently.
• Provides guidance to less experienced medical writers and external vendors.

Ideal Candidate

• Bachelors in science (advanced degree is a plus), with 8 years of experience in medical writing in the pharmaceutical or biotech industry.
• Ability to understand, critically analyze, and interpret data and summarize complex results in an unambiguous, concise, and scientifically accurate manner
• Well-developed interpersonal and communication skills, with experience interacting with and influencing people, and building strong, positive relationships
• Proven organizational skills and the ability and flexibility to work across a variety of teams and manage multiple competing priorities in a fast-paced startup environment
• Experience with independently authoring a range of scientific documents and the ability to oversee such authoring done by third parties
• Detail-oriented, with exceptional organizational and project management skills
• Proficient in using scientific writing tools (eg, Microsoft Office suite, document management systems, reference management software) and ability to quickly learn new software applications.

The anticipated salary range for candidates for this role will be $160,000 to $175,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.