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Scientific Writer

Role overview

Qualifications

  • Bachelor's degree in a life sciences discipline; advanced degree (MS or PhD) preferred
  • Relevant combination of scientific and regulatory writing experience supporting nonclinical development programs
  • Experience working with laboratory-generated pharmacology, PK, and/or PD data on a nonclinical drug development team
  • Knowledge of drug development, eCTD guidelines, and ICH, FDA, and EMA/CHMP nonclinical requirements

Responsibilities

  • Independently author nonclinical PK/PD study reports, eCTD summaries, and Investigator's Brochure content
  • Lead development of integrated regulatory narratives that synthesize PK, PD, and mechanistic data
  • Collaborate with scientists and cross-functional teams to interpret data and ensure consistent PK/PD messaging across programs
  • Coordinate data inputs, reviews, timelines, and stakeholder communications to support high-quality, on-time deliverables

Key facts

Hard skills

Other skills

  • Communication
  • Teamwork

About the company

Regeneron logo

Regeneron

Biotechnology

At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.

Company details

Company typeLarge
IndustryBiotechnology
Company size10001

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Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Scientific Writer to join our Scientific Writing team, translating complex nonclinical PK/PD and pharmacology data into clear regulatory narratives that support critical drug development and regulatory decisions. In this role, you will serve as the primary Scientific Writing partner to Translational Pharmacokinetics & Pharmacodynamics and Nonclinical Pharmacology, helping teams communicate exposure-response relationships, dose selection rationale, and mechanistic insights across development programs.


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


When & where:

  • Location: [Insert location]
  • Work model/flexibility: [Insert work model]

Discover your role:

  • Independently author nonclinical PK/PD study reports, eCTD summaries, and Investigator's Brochure content
  • Lead development of integrated regulatory narratives that synthesize PK, PD, and mechanistic data
  • Collaborate with scientists and cross-functional teams to interpret data and ensure consistent PK/PD messaging across programs
  • Coordinate data inputs, reviews, timelines, and stakeholder communications to support high-quality, on-time deliverables
  • Drive process improvements through authoring guidance, workflow optimization, and AI-enabled writing and quality-control solutions
  • Serve as the scientific writing lead for assigned programs, providing strategic document planning and cross-functional coordination

This role requires:

  • Bachelor's degree in a life sciences discipline; advanced degree (MS or PhD) preferred
  • Relevant combination of scientific and regulatory writing experience supporting nonclinical development programs
  • Experience working with laboratory-generated pharmacology, PK, and/or PD data on a nonclinical drug development team
  • Knowledge of drug development, eCTD guidelines, and ICH, FDA, and EMA/CHMP nonclinical requirements, including eCTD Modules 2.4, 2.6, and 4
  • Experience using document authoring, review, and collaboration tools in a regulated environment

Submitting a cover letter is strongly encouraged.

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)

$109,900.00 - $179,300.00

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
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