Senior/Medical Writer - Global Medical Affairs

United Therapeutics Corporation • NC

129d

About The Position

United Therapeutics seeks a Senior/Medical Writer to support Global Medical Affairs Phase 3b/4 research and early phase product development. The role involves independent research, writing, and editing of various regulatory documents, including clinical study protocols, reports, and investigator's brochures. The writer will collaborate with clinicians, clinical scientists, and biostatisticians to ensure accurate representation of study results and objectives. Responsibilities include leading the development of complex clinical and regulatory documents, providing strategic input into document planning, and facilitating cross-functional review cycles. The position requires maintaining document tracking systems and contributing to the improvement of medical writing processes while ensuring adherence to internal style guides and regulatory standards.

Requirements

• Bachelor’s Degree in a science-related field.
• 5+ years of experience in medical writing.
• Excellent interpersonal skills.
• Attention to detail.

Nice To Haves

• Master’s Degree in a science-related field.
• PhD or PharmD with previous medical writing responsibilities.
• 2+ years of experience in managing complex medical writing projects.
• 2+ years of experience in global/regional regulatory medical writing.
• 2+ years of experience in medical communications writing.

Responsibilities

• Research, write, and edit abstracts, manuscripts, posters, and regulatory documents.
• Collaborate with clinicians, clinical scientists, and biostatisticians to interpret study results.
• Serve as lead author for complex clinical and regulatory documents.
• Provide strategic input into document planning and content development.
• Partner with various departments to synthesize data for document development.
• Facilitate cross-functional review cycles and ensure timely delivery of documents.
• Collaborate with external HCPs, KOLs, and scientific leads to author manuscripts and presentations.
• Lead the development of scientific slide decks and educational materials.
• Establish and maintain document tracking systems.
• Contribute to the creation and governance of clinical and medical writing SOPs.
• Author technical reports and briefing documents for early-phase clinical development.
• Provide guidance and mentorship to junior writers.

Benefits

• Medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans (401k and ESPP).
• Paid time off & paid parental leave benefits.
• Disability benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees