Executive Director, Medical Writing

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking an Executive Director
, to join our Medical Writing team.

The Executive Director, Medical Writing (EDMW) provides strategic leadership for Medical Writing authoring, technology, and resourcing across therapeutic areas and compounds, with accountability for Medical Writing and Editor activities supporting clinical regulatory documents and submissions. The EDMW establishes department writing strategies, guidelines, templates, standard timelines, and SOPs in alignment with applicable regulatory requirements and industry standards. This role leads the incorporation of technology into Medical Writing strategy to improve authoring processes, document quality, operational efficiency, and scalability.

The EDMW also leads and develops staff, oversees performance management, recruiting, coaching, and training, and manages department budget planning and resourcing needs.

This position offers the opportunity to contribute to a fast‑growing, science‑driven organization making a meaningful difference to patients worldwide.

• Work Location:
  
  Tarrytown, NY or Warren, NJ
• 4 days per week on site
• 25% Travel may be required

• Develops and leads Medical Writing submission, authoring, editing, and document review strategies and standards across therapeutic areas and compounds, ensuring alignment with applicable regulatory guidance, industry standards, and internal quality expectations.
• Leads the incorporation of technology into Medical Writing and Editing responsibilities, including authoring tools, editing platforms, automation, document management capabilities, and technology‑enabled workflows that improve document quality, consistency, efficiency, compliance, and scalability.
• Establishes, maintains, and continuously improves department guidelines, templates, standard timelines, quality standards, editing expectations, and SOPs to support consistent, compliant, and efficient document development and review.
• Oversees Medical Writing and Editing activities supporting clinical regulatory documents, including planning, authoring, review coordination, quality control, editing, finalization, and delivery of submission‑ready documents.
• Develops and executes resourcing strategies, including internal staffing plans, editor and writer allocation, external consultant support, and outsourcing models for Medical Writing and Editing activities.
• Tracks document development, editing workload, submission priorities, and long‑term staffing needs, and allocates work appropriately among department members, external consultants, and vendors.
• Provides leadership and guidance to Medical Writing and Editing staff, including oversight of document strategy, content development, editing standards, review processes, issue resolution, stakeholder communication, and delivery of high‑quality clinical regulatory documents.
• Manages and develops staff, including performance management, recruiting, coaching, training, annual performance reviews, succession planning, and professional development.
• Represents Medical Writing at cross‑company, compound, and therapeutic area meetings by driving discussion, presenting as a functional leader, articulating document strategy and timelines, identifying decision makers, and focusing teams on results and actions.
• Leads and participates in technology adoption, process improvement efforts, standards development, and cross‑functional working groups within Medical Writing and across Global Development.
• Oversees external writers, editors, and writing projects to ensure deliverables meet internal process, quality, technology‑use, and timeline…