About Us

About the Role

As the Director, Medical Writing, you will support the development of high-quality clinical and regulatory documents that support our drug development programs.

Reporting to our Senior Director, Medical Writing, you will bring scientific expertise, and the ability to thrive in a dynamic start-up environment. Day to day you will lead critical clinical and regulatory documents from start to finish by working closely with Clinical Development, Regulatory Affairs, Biostatistics, and other stakeholders. You will support cross-functional teams to ensure data presentation and messaging is clear and consistent across documents in addition to ensuring timely and compliant document delivery. You must have experience with leading the development of clinical and regulatory documents in collaboration with cross-functional teams in order to be successful in this role.

This is an exciting opportunity to be a critical part of drug development and regulatory submissions at a growing organization with an expanding pipeline. This is a fully remote position, with opportunities to travel and meet with teams as needed. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Author, review, and manage clinical and regulatory documents including:

• Clinical Study Protocols and Amendments
• Investigator Brochures
• Clinical Study Reports (CSRs)
• Regulatory submission documents (e.g., INDs, NDAs, MAAs)
• Collaborate with internal teams and external vendors to manage timelines and deliverables.
• Provide input on document planning and regulatory submissions.
• Ensure documents comply with ICH guidelines, regulatory requirements, and company standards.
• Develop and maintain templates, style guides, and best practices for medical writing.
• Mentor junior writers and contribute to building the medical writing function.

Experience

• Advanced degree in life sciences (PhD, PharmD, or MS preferred).
• 8+ years of medical writing experience in the biotech/pharmaceutical industry, including regulatory submissions.
• Strong knowledge of ICH, FDA, and EMA guidelines.
• Excellent writing, editing, and project management skills.
• Ability to work independently in a fast-paced, start-up environment.
• Ability to work collaboratively and coordinate the efforts to resolve comments with team members
• Flexible and able to adapt to changing deadlines and priorities
• High attention to detail
• Experience with StartingPoint templates, PleaseReview, and Microsoft Project is a plus.