Director, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and implement the medical writing strategy for the company, focusing on clinical development, regulatory submissions, and readiness for product launches.

• Collaborate with Regulatory Affairs to ensure strategic alignment, preparation for submissions, consistent messaging, and adherence to regulatory requirements.

• Convert intricate clinical, statistical, safety, translational, and manufacturing data into concise scientific narratives.

• Lead the authorship, review, and finalization of BLA documents, Module 2 clinical summaries, Clinical Study Protocols, Investigator Brochures, CSRs, SAP summaries, ISS, ISE, and responses to inquiries from health authorities.

• Work together with Clinical Development and Biometrics to develop comprehensive evidence packages.

• Act as the primary representative for medical writing on cross-functional program and submission teams.

• Ensure alignment on scientific messaging, project timelines, and review processes.

• Set up document planning, governance, standards, templates, and quality systems.

• Maintain consistency across protocols, SAPs, CSRs, safety documents, and regulatory summaries.

• Contribute to inspection preparedness and document traceability.

• Develop streamlined document creation processes.

• Establish a scalable medical writing operating model and supervise contract writers, editors, and publishing vendors.

• Recognize risks, resource limitations, and crucial submission dependencies, implementing plans to mitigate these issues.

• Adopt best practices for content reuse, document standards, authoring technologies, and quality assurance.

• Create and sustain writing templates, style guides, and document repositories.

• Ensure compliance with ICH, GCP, FDA, EMA, and company-specific quality standards.

⛳️ Requirements

• Advanced scientific degree preferred (PhD, PharmD, MD, or equivalent); a Master's degree with extensive relevant experience will also be considered.

• Over 10 years of experience in medical writing within the biotechnology or pharmaceutical sectors.

• Proven experience in authoring and leading significant regulatory submission documents, including support for BLA/NDA submissions.

• Preferably have experience in cell therapy; experience in oncology, gene therapy, or advanced therapeutics may also be acceptable.

• Strong knowledge of ICH guidelines and global regulatory standards.

• Experience in managing external medical writing vendors and consulting resources.

• Exceptional scientific communication and project management abilities.

• Capability to distill complex clinical and statistical information into clear and compelling scientific narratives.

• Proven ability to thrive in dynamic, cross-functional small to mid-sized biotech environments.

• Strategic agility to balance long-term submission planning with immediate execution needs.

• Experience in building and leading lean teams supported by strong external consultants.

• Ability to establish and lead disciplined methodologies that yield high-quality deliverables.

• Familiarity with ICH, GCP, FDA, and EMA regulations.

• Experience in supporting BLA/NDA regulatory submissions.

🏝️ Benefits

• Annual incentive bonus based on a percentage of the actual base salary.

• Long-term incentives provided through employee stock options.

• Comprehensive coverage for medical, dental, and vision needs.

• Company contributions towards health savings and retirement accounts.

• Generous paid time off policy.

• Access to wellness initiatives.

• Abundant opportunities for career advancement.

• Flexible remote work options.