Position SummaryThis full-time role will play a key part in delivering high-quality clinical and regulatory documentation and contributing to the development of efficient medical writing processes across the organization. The successful candidate will oversee the preparation of clinical and regulatory documents while collaborating closely with cross-functional partners, including Clinical Development, Regulatory Affairs, Quality, and Program Management.
This role reports to the Senior Director of Medical Writing and will contribute to shaping medical writing capabilities as the company continues to grow.
Key Responsibilities- Oversee the preparation, review, and finalization of clinical and regulatory documents, including clinical study protocols, clinical study reports, investigator brochures, and regulatory submissions.
- Ensure documents are scientifically accurate, clear, and compliant with applicable regulatory guidelines, company standards, and timelines.
- Collaborate with clinical, regulatory, and scientific teams to gather and interpret data and ensure effective communication of complex scientific information.
- Contribute to the development and maintenance of medical writing processes, templates, and best practices to improve quality and efficiency.
- Participate in cross-functional meetings as the medical writing representative and provide input on document strategy and planning.
- Manage project timelines and coordinate resources to support timely document delivery.
- Stay current with regulatory guidance, industry trends, and best practices in medical writing.
- Other responsibilities as assigned.
Qualifications - Advanced degree in life sciences, medical writing, or a related field (PhD, MD, or equivalent preferred).
- 5+ years of medical writing experience in the biotechnology or pharmaceutical industry.
- Demonstrated experience authoring and coordinating clinical and regulatory documents.
- Prior experience providing mentorship of junior writers or managing vendors is preferred.
- Strong working knowledge of regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
- Excellent written and verbal communication skills, with the ability to clearly convey complex scientific information.
- Strong organizational, problem-solving, and collaboration skills.
- Ability to work effectively in a fast-paced, team-oriented environment with evolving priorities.
- Strong interpersonal skills and the ability to work cross-functionally.
TravelYou will be expected to travel periodically based on the needs of the business to the extent requested by the Company, including attendance at Together Weeks, Together Days, and functional meetings as requested by the Company.
