Medical Writer
Regeneron
4 months ago
On-site
United States
Clinical Research and Development
Medical Writer (MW)
Responsibilities:
- Work with team members (with MW lead oversight) to create clinical document content, including CSRs, protocols, ICFs, narratives, and IBs across therapeutic areas.
- May serve as lead for a compound; manage and facilitate document completion.
- Ensure adherence to internal standards and procedures.
- Maintain document standardization using 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; keep discussions on track with minimal fuss.
- Follow discussions to conclusion, synthesize messages, and present clear, accurate prose quickly.
- Ensure adherence to applicable guidelines, templates, and SOPs; remain compliant with internal training.
Qualifications/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, and PowerPoint; familiarity with electronic document management systems.
Benefits:
- Comprehensive benefits vary by location; in the U.S. may include medical, dental, vision, life, and disability insurance; fitness centers; 401(k) company match; equity awards; annual bonuses; paid time off; and paid leaves.
Application Instructions:
- Apply now.
Responsibilities:
- Work with team members (with MW lead oversight) to create clinical document content, including CSRs, protocols, ICFs, narratives, and IBs across therapeutic areas.
- May serve as lead for a compound; manage and facilitate document completion.
- Ensure adherence to internal standards and procedures.
- Maintain document standardization using 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; keep discussions on track with minimal fuss.
- Follow discussions to conclusion, synthesize messages, and present clear, accurate prose quickly.
- Ensure adherence to applicable guidelines, templates, and SOPs; remain compliant with internal training.
Qualifications/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, and PowerPoint; familiarity with electronic document management systems.
Benefits:
- Comprehensive benefits vary by location; in the U.S. may include medical, dental, vision, life, and disability insurance; fitness centers; 401(k) company match; equity awards; annual bonuses; paid time off; and paid leaves.
Application Instructions:
- Apply now.