New · posted Nov 1
Regeneron · Biotechnology
Executive Director, Medical Writing
- Tarrytown, NY +1 more
- Hybrid
- Full-time
- Director
The role
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.
What you need
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
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.
What you'll do
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.
Pay and benefits
$285,600 – $475,900 a year
Employer provided$285,600.00 - $475,900.00
Annual bonuses or incentive plans
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Tarrytown, NY +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Warren, NJ
More jobs in Tarrytown, NY +1 moreWorking conditions
When & where
Work Location: Tarrytown, NY or Warren, NJ
4 days per week on site
25% Travel may be required
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 81% above the US median for Clinical Evaluation & Medical Writing roles at this level.
This roleEmployer provided
Director roles in the US12 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $285,600 | — | $475,900 |
| All US (middle half) | $195,000 | $210,000 | $232,750 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 39 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs17
- Collaboration and leadership13
- GMP and compliance4
- Regulatory submissions4
- Quality systems and risk1
- Clinical trial conduct1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Regeneron on Regulatory Jobs
- 163
- Open roles
- 140
- Distinct roles
- 11
- Locations
By discipline
- Clinical69 42%
- Quality67 41%
- Regulatory27 17%
By level
- Associate & Specialist53 33%
- Director49 30%
- Manager46 28%
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Executive Director, Medical Writing at Regeneron
Open until filled. $286K–$476K a year, employer provided.