Are you a skilled regulatory medical writer ready to advance your career? Our client, an innovative biopharmaceutical company, is seeking an Associate Director/Director of Regulatory Medical Writing to join their team.

About the Role

This position is central to producing high-quality, regulatory-compliant clinical documentation, supporting global submissions, and advancing drug development programs. You’ll work cross-functionally to author and manage clinical and regulatory documents such as CSRs, protocols, investigator brochures (IBs), and marketing applications (BLA, NDA, MAA). Additionally, you’ll oversee outsourced medical writing projects, ensuring consistency, accuracy, and adherence to regulatory standards.

Key Responsibilities

• Develop, author, and edit clinical and regulatory documents for global submissions.
• Collaborate with clinical and cross-functional teams to create submission-ready materials, including regulatory briefing documents and safety reports.
• Manage outsourced writing vendors, ensuring high-quality deliverables that align with internal standards.
• Maintain and refine document templates and style guides to support standardization.
• Oversee document preparation, including QC, formatting, and eCTD readiness.

What We’re Looking For

• A Bachelor’s degree and 7+ years of experience as a regulatory writer in the biopharmaceutical industry.
• Proficiency in preparing documents for submissions in electronic Common Technical Document (eCTD) format.
• Solid understanding of FDA/ICH guidelines, GCP, and familiarity with GLP and GMP standards.
• Strong organizational, project management, and technical writing skills.
• Expertise in Microsoft Office, Adobe Acrobat, and scientific graphing applications.

Behavioral Competencies

• Excellent collaboration and relationship-building skills.
• Analytical mindset with exceptional problem-solving abilities.
• Attention to detail and adaptability in a fast-paced environment.

Why Apply?

This is an incredible opportunity to contribute to transformative drug development programs while collaborating with a forward-thinking team. Join a company committed to advancing therapies for unmet medical needs and making a difference in patients' lives.

Ready to take the next step in your career? Apply now to be part of this exciting journey!