Clinical Regulatory Writing Associate Director

Pay rate: $75.30/hr • Duration: 12 months • Location: Gaithersburg, MD • Hybrid (2 days remote, 3 days on-site)

About the role

The Clinical Regulatory Writing team provides expert communication leadership to drug projects. We author strategically important clinical-regulatory documents that are label-focused and aligned with project strategies, regulatory requirements, and best practices. Supporting core therapeutic areas in all phases of clinical development, our vision is to drive industry-leading strategic communication excellence for successful submissions and approvals.

Responsibilities

• Independently manage clinical regulatory writing activities across a complex portfolio.
• Author the most complex clinical-regulatory documents, ensuring regulatory, technical, and quality standards are met, and that best practices are applied.
• Provide strategic communications leadership to project teams, establish communication standards, and continuously advocate for quality and efficiency.
• When acting as submission lead, drive the development of the clinical Submission Communication Strategy (cSCS).
• Lead internal and external authoring teams, partnering with vendor medical writers to ensure timely, quality delivery.
• Drive clinical interpretation of complex data and distill it into clear, concise, and accurate messages that meet customer information requirements.
• Demonstrate strategic thinking and strategic review capabilities.
• Collaborate proactively with other functions at the program level.
• Support the development of Clinical Regulatory Writing Managers.
• Drive continuous improvement and operational excellence in communications leadership, representing the skillset on drug and non-drug projects as needed.

Requirements

• Master’s degree in Life Sciences or a related discipline.
• Significant medical writing experience within the pharmaceutical industry or a CRO.
• Ability to advise and lead communication projects.
• Understanding of drug development and communication processes from development, launch, through life cycle management.
• In-depth knowledge of regulatory and technical requirements relevant to the role.

Qualifications

Desirable: Advanced degree in a scientific discipline (Ph.D.).

Schedule

8:00 AM–4:00 PM or 9:00 AM–5:00 PM