Senior Medical Writer

Regeneron Pharmaceuticals

1d

About The Position

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 6-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.

Requirements

• 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.

Nice To Haves

• strong organizational and interpersonal skills
• experience in clinical document reading, writing, and editing

Responsibilities

• 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.

Benefits

• 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
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Career Level: Mid Level