Executive Director, Medical Writing

Regeneron Pharmaceuticals • Warren, MI

1d • Onsite

About The Position

The Executive Director, Medical Writing (EDMW) provides strategic leadership for Medical Writing authoring, technology, and resourcing across therapeutic areas and compounds. The role is accountable for Medical Writing and Editing activities supporting clinical regulatory documents and submissions, and establishes department strategies, guidelines, templates, standard timelines, and SOPs aligned with regulatory requirements and industry standards.

The EDMW leads technology adoption to improve authoring processes, document quality, operational efficiency, and scalability. The role also oversees staff development and performance, recruiting, coaching, training, department budget planning, and resourcing. The position is based in Tarrytown, NY or Warren, NJ, with an expectation to work onsite four days per week; travel may be required up to 25%.

Requirements

• Bachelor's degree; an advanced degree is preferred.
• Minimum 17 years of industry experience, including at least 10 years of Medical Writing experience.
• Minimum 7 years of management experience.
• Expert knowledge of the clinical research process and regulations and guidelines.
• Expert clinical document reading, writing, and editing experience.
• Excellent organizational, interpersonal, and communication skills.
• Excellent knowledge of MS Word, Adobe Acrobat, PowerPoint, electronic document management systems, authoring and editing platforms, document collaboration tools, automation-enabled workflows, and other technologies used for clinical regulatory document development.
• Demonstrated ability to evaluate, implement, and promote technology solutions that improve Medical Writing and Editing quality, consistency, efficiency, compliance, and scalability.
• Ability to lead and manage multiple projects.
• Thorough understanding of ICH GCP guidelines.

Nice To Haves

• Advanced degree.

Responsibilities

• Develop and lead Medical Writing submission, authoring, editing, and document review strategies and standards across therapeutic areas and compounds.
• Lead incorporation of technology into Medical Writing and Editing, including authoring tools, editing platforms, automation, document management capabilities, and technology-enabled workflows.
• Establish, maintain, and continuously improve department guidelines, templates, standard timelines, quality standards, editing expectations, and SOPs.
• Oversee planning, authoring, review coordination, quality control, editing, finalization, and delivery of clinical regulatory documents.
• Develop and execute resourcing strategies, including internal staffing plans, writer and editor allocation, consultant support, and outsourcing models.
• Track document development, editing workload, submission priorities, and long-term staffing needs; allocate work among department members, consultants, and vendors.
• Lead and guide Medical Writing and Editing staff on document strategy, content development, editing standards, review processes, issue resolution, stakeholder communication, and delivery.
• Manage and develop staff through performance management, recruiting, coaching, training, annual reviews, succession planning, and professional development.
• Represent Medical Writing at company, compound, and therapeutic area meetings; articulate document strategy and timelines, identify decision makers, and focus teams on results and actions.
• Lead and participate in technology adoption, process improvement, standards development, and cross-functional working groups within Medical Writing and Global Development.
• Oversee external writers, editors, and writing projects, including vendor selection, onboarding, collaboration management, and performance oversight, to ensure quality and timely deliverables that meet internal process and technology expectations.
• Remain compliant with internal training requirements and ensure staff are trained on relevant Medical Writing, Editing, regulatory, process, and technology expectations.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability coverage, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive