(Associate) Director, Medical Writing

Key Responsibilities:
- Oversee preparation, review, and finalization of clinical and regulatory documents (clinical study protocols/reports, investigator brochures, 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 communicate complex scientific information.
- Develop and maintain medical writing processes, templates, and best practices to improve quality and efficiency.
- Participate in cross-functional meetings as the medical writing representative; 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 related field (PhD, MD, or equivalent preferred).
- 5+ years of medical writing experience in biotechnology or pharmaceutical industry.
- Demonstrated experience authoring and coordinating clinical and regulatory documents.
- Prior mentorship of junior writers or vendor management experience preferred.
- Strong working knowledge of regulatory requirements and guidelines (ICH, FDA, EMA).
- Excellent written and verbal communication skills.
- 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 ability to work cross-functionally.

Travel:
- Periodic travel as requested by the business, including attendance at Together Weeks, Together Days, and functional meetings.