Medical Writer

Regeneron Uk Limited • Armonk, NY

275d • $108,300 - $176,700

About The Position

The Medical Writer (MW) works with team members to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. The MW may serve as lead for a compound and is expected to resolve issues and escalate problems, as necessary. As a Medical Writer, a typical day may include: working with team members and with MW lead oversight to create the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. The MW may serve as lead for a compound and is expected to manage and facilitate completion of documents. Ensures adherence to internal standards and procedures. Maintains document standardization via model documents/templates and appropriate peer review. Remains current with writing guidelines and industry standards, participates in educational opportunities, reads professional publications. Under supervision of more senior MW staff, the MW contributes to: driving document development meetings, articulating document strategy and timelines, identifying the appropriate parties for a document content decision, and if a discussion is faltering, bringing the discussion back on track with minimal fuss. Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly. Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area. Remains compliant with internal training.

Requirements

• Bachelor's degree (advanced degree preferred).
• 1 year of relevant experience.
• Awareness of the clinical research process and regulations/guidelines.
• Scientific and technical reading, writing, and editing skills.
• Organizational, interpersonal and communication skills.
• Working knowledge of MS WORD, Adobe Acrobat, PowerPoint, and familiarity with electronic document management systems.

Responsibilities

• Create the content of clinical documents including CSRs, protocols, ICFs, narratives, and IBs.
• Serve as lead for a compound and manage the completion of documents.
• Ensure adherence to internal standards and procedures.
• Maintain document standardization via model documents/templates and appropriate peer review.
• Stay current with writing guidelines and industry standards.
• Participate in educational opportunities and read professional publications.
• Drive document development meetings.
• Articulate document strategy and timelines.
• Identify appropriate parties for document content decisions.
• Synthesize discussions and present clear accurate prose.

Benefits

• Health and wellness programs.
• Fitness centers.
• Equity awards.
• Annual bonuses.
• Paid time off for eligible employees.

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree