Senior Medical Writer

Overview

The Senior Medical Writer (SMW) writes content for clinical documents (CSRs, protocols, ICFs, narratives, IBs) in a variety of therapeutic areas. The SMW tracks writing projects, adheres to regulatory guidelines and department document standards, may serve as lead for a compound, and may review the work of junior/outsourced writers as well as CSR-related documents (Statistical Analysis Plans, TFLs) to ensure appropriate content.

• Write content for clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other regulatory documents may be provided.
• Participate in process improvement initiatives, working groups, and cross-functional activities within MW and Global Development.
• Manage processes and priorities; solve problems; foster collaboration to resolve conflicts.
• Review the work of junior and outsourced medical writers as needed.
• Review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion.
• Write in plain language style as appropriate (e.g., for ICFs).
• Explain complex medical/scientific concepts (e.g., medical procedures, clinical study design, drug mechanisms) to a lay or patient audience.
• Mentor junior staff as appropriate.
• Ensure adherence to applicable guidelines, templates and SOPs for all medical writing documents in the therapeutic area.
• Maintain compliance with internal training requirements.

• Bachelor's degree (advanced degree preferred).
• Minimum of 3 years of relevant medical writing experience, including working knowledge of biostatistics.
• Strong knowledge of the clinical research process and regulations/guidelines.
• Clinical document reading, writing, and editing experience.
• Strong organizational, interpersonal and communication skills.
• Proficiency in MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems.
• Ability to manage multiple projects.
• Familiarity with ICH GCP guidelines.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way. Regeneron’s inclusive culture provides comprehensive benefits that vary by location. In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves for eligible employees at all levels.

For more information about Regeneron benefits in the US, visit the total rewards page. For other countries, please speak to your recruiter.

Please be advised that at Regeneron, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site policy and expectations for your role and location.

Regeneron is an equal opportunity employer. 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, marital status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws. The Company will provide reasonable accommodation to known disabilities or chronic illnesses of an otherwise qualified applicant, unless the accommodation would impose undue hardship.

Salary range (annually): $ - $