Principal Medical Writer, Medical Writing

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 Principal Medical Writer to join our Medical Writing team, supporting Global Development in a hybrid work model. In this role, you will lead clinical document strategy and development for assigned compounds while collaborating with Medical Directors, Biostatisticians, Regulatory Liaisons, and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Tarrytown, Warren, Uxbridge, Dublin, Tokyo, or Remote

Work model: Hybrid

Discover your role:

• •Lead clinical document strategy for assigned compounds across therapeutic areas.
• •Drive development of CSRs, protocols, ICFs, Investigator’s Brochures, narratives, and regulatory documents.
• •Lead submission document writing with Medical Directors, Biostatisticians, and Regulatory Liaisons.
• •Represent Medical Writing in document development meetings and guide strategy discussions.
• •Oversee junior and outsourced medical writers while contributing independent authoring.
• •Review Statistical Analysis Plans and TFLs for clinical document content.
• •Contribute to Medical Writing and Global Development process improvement initiatives.
• •You build collaboration, resolve challenges, and keep complex projects moving forward.

This role requires:

• •Bachelor’s degree required; advanced degree preferred.
• •Minimum 7 years of medical writing experience, including strong biostatistics knowledge.
• •Expert knowledge of clinical research processes, regulations, and guidelines.
• •Expert experience reading, writing, and editing clinical documents.
• •Experience authoring regulatory submission documents, including Module 2 documents.
• •Thorough understanding of ICH Good Clinical Practice guidelines.
• •Knowledge of applicable guidelines, templates, and SOPs for medical writing.
• •Proficiency with Microsoft Word, Adobe Acrobat, PowerPoint, and electronic document management systems.
• •Ability to manage multiple projects and competing priorities.
• •Excellent organizational, interpersonal, and communication skills.
• •Management experience preferred.

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.