Scientific Writer

Regeneron Pharmaceuticals; United States; Remote; USD 110,000 - 179,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a Scientific Writer to translate complex nonclinical PK/PD and pharmacology data into regulatory narratives; you will partner with Translational Pharmacokinetics & Pharmacodynamics and Nonclinical Pharmacology teams to communicate exposure-response relationships and dose rationale.

You will author nonclinical study reports, develop integrated regulatory narratives, and drive process improvements using AI-enabled writing tools to ensure on-time, high-quality

Qualifications

• Bachelor's degree in a life sciences discipline; MS or PhD preferred.
• Experience supporting nonclinical development and regulatory writing.
• Experience with pharmacology, PK, and/or PD data on nonclinical teams.
• Knowledge of eCTD modules 2.4, 2.6, and 4; ICH, FDA, EMA/CHMP requirements.
• Experience using regulated document authoring and collaboration tools.

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
• 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

Skills

Nonclinical PK/PD

Regulatory writing

Cross-functional collaboration

Data interpretation

eCTD familiarity

ICH/FDA/EMA guidelines

Education

MS or PhD in life sciences

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

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.

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