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Senior Medical Writer

Remote, USA Full-time Posted 2025-11-24
At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. As we work across our growing 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. We’re seeking a dedicated Senior Medical Writer to join our dynamic Medical Writing team. In this pivotal role, you will craft and refine clinical documents that drive innovation and compliance in a variety of therapeutic areas. With opportunities to lead projects, mentor junior writers, and contribute to regulatory documents, this position offers a chance to make meaningful contributions while advancing your career in a supportive and collaborative environment. This is a 9-month contract. A Typical Day: As a Senior Medical Writer, your day may include: • Writing and editing clinical documents such as CSRs, protocols, ICFs, narratives, and IBs. • Collaborating with clinical teams to articulate document strategies and timelines. • Representing Medical Writing at meetings and driving document development discussions. • Reviewing CSR-related documents (e.g., Statistical Analysis Plans, TFLs) to ensure content accuracy. • Mentoring junior writers and fostering their growth in medical writing. • Ensuring adherence to regulatory guidelines, templates, and SOPs for therapeutic area documentation. • Contributing to process improvement initiatives across Medical Writing and Global Development teams. This Role May Be For You If: • You excel at explaining complex medical/scientific concepts to diverse audiences, including lay or patient groups. • You thrive in collaborative environments and can foster teamwork to resolve conflicts effectively. • You are detail-oriented and have a strong ability to manage multiple projects simultaneously. • You have a knack for synthesizing discussions and presenting clear, accurate prose quickly. • You are committed to adhering to guidelines and standards while continuously improving processes. • You enjoy mentoring and supporting the development of junior staff members. To Be Considered: Applicants must hold a Bachelor’s degree (advanced degree preferred) and have a minimum of 3 years of relevant medical writing experience, including knowledge of biostatistics and clinical research processes. Familiarity with ICH GCP guidelines and proficiency in MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems are essential. Preferred qualifications include strong organizational and interpersonal skills and experience in clinical document reading, writing, and editing. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Apply tot his job Apply To this Job

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