Director of Medical Writing in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director of Medical Writing based in the United States.

This senior leadership role sits at the intersection of clinical development, regulatory strategy, and scientific communication, ensuring the creation of high-quality documentation that supports global drug development programs from early clinical phases through regulatory submission. The position combines hands-on scientific writing with team leadership, overseeing internal writers, contractors, and vendors while directly contributing to key regulatory documents. It plays a critical role in ensuring consistency, compliance, and clarity across clinical and regulatory deliverables that impact patient access to innovative therapies. Operating in a fast-paced biotech environment, the role partners closely with cross-functional experts to shape clinical narratives and submission strategy. It also contributes to the development of departmental infrastructure, standards, and long-term medical writing strategy. This is a highly visible role with both strategic influence and operational accountability across multiple programs.

This role is responsible for leading and/or authoring high-impact regulatory and clinical documentation while ensuring consistency, quality, and compliance across all medical writing activities. It involves both people leadership and hands-on content development in support of global drug development programs.

• Manage and mentor medical writers (employees, contractors, and vendors), ensuring alignment with project goals, timelines, and quality standards
• Author and/or oversee the development of key regulatory documents including protocols (Phase 1–4), clinical study reports, investigator brochures, informed consent forms, and eCTD modules (INDs, BLAs, MAAs)
• Ensure all documentation meets internal standards, regulatory requirements, and submission readiness expectations
• Collaborate with cross-functional teams and subject matter experts to develop accurate, well-structured scientific content for regulatory submissions and health authority interactions
• Drive standardization of medical writing practices through templates, style guides, lexicons, and document libraries
• Contribute to inspection readiness by maintaining documentation quality, consistency, and compliance across programs
• Support departmental strategy development, resource planning, and continuous improvement initiatives

The ideal candidate brings deep experience in pharmaceutical or biotech medical writing, with proven leadership capabilities and strong regulatory submission expertise. They are comfortable operating in a matrixed, fast-paced environment and can balance strategic oversight with detailed scientific execution.

• Bachelor’s degree in a scientific or clinical discipline required; advanced degree (PhD preferred)
• 7+ years of sponsor-side pharmaceutical or biotech medical writing experience (CRO experience considered)
• Proven experience authoring eCTD Module 2 and Module 5 documents for global regulatory submissions (INDs, BLAs, MAAs)
• Experience managing or mentoring medical writers, including contractors and external vendors
• Strong understanding of clinical development, drug development phases, and regulatory guidance frameworks
• Ability to interpret complex scientific data and translate it into clear, compliant regulatory documents
• Excellent written and verbal communication skills with strong attention to detail and quality standards
• Strong organizational and project management skills with the ability to manage multiple priorities simultaneously
• Proficiency in MS Office and familiarity with regulatory writing tools and processes

• Competitive base salary with annual bonus eligibility and long-term incentive opportunities
• Comprehensive health, dental, and vision insurance coverage
• Retirement savings plans with employer contributions
• Generous paid time off and holiday schedule
• Flexible work arrangements, including remote options
• Life, disability, and additional supplemental insurance offerings
• Professional development opportunities and leadership growth pathways
• Exposure to global regulatory programs and high-impact clinical development projects