About this role
Executive Director, Medical Writing
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locations
TARRYTOWN
Warren
time type
Full time
posted on
Posted Yesterday
job requisition id
R50446
Build our future together:
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.
When & where:
Work
Location
Tarrytown, NY or Warren, NJ
4 days per week on site
25% Travel may be required
Discover your role:
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 expectations, including vendor selection, onboarding, collaboration management, and performance oversight.
Remains compliant with internal training requirements and ensures staff are appropriately trained on relevant Medical Writing, Editing, regulatory, process, and technology expectations.
This role requires:
Bachelor's degree (advanced degree preferred)
Minimum of 17years of industry experience to include a minimum of 10 years of Medical Writing experience
Minimum 7 years management experience
Expert knowledge of the clinical research process and regulations/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 to support 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
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually) $285,600.00 - $475,900.00
About Us
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.
Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.
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