Remote Senior Medical Writer: Clinical Documents Leader

Syneos Health, Inc.

Missouri

Remote

USD 81,000 - 176,000

Full time

42 hours ago
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Benefits offered by this job

Health benefits
401k match
Employee Stock Purchase Plan
Paid time off

Job summary

Syneos Health, Inc. is seeking a Senior Medical Writer (FSP) with proven experience in clinical document writing, including protocols, CSRs, and IBs. The role emphasizes meeting regulatory standards while delivering high-quality documents on schedule.

The position supports remote work with flexibility across EST/CST time zones and involves collaboration with global teams to accelerate patient access to therapies.

Qualifications

  • Experience producing clinical study protocols, CSRs and IBs.
  • Ability to manage medical writing across studies within budgets and timelines.
  • Familiarity with ICH E3 guidelines and regulatory standards.
  • Mentor junior writers and coordinate editorial reviews.
  • Collaborate with cross-functional teams (data management, biostatistics, regulatory).

Responsibilities

  • Leads clear and accurate completion of medical writing deliverables across studies.
  • Coordinates medical writing activities with other departments with minimal supervision.
  • Ensures regulatory and company templates and style guides are followed.
  • Reviews documents for scientific content, clarity, and formatting.
  • Mentors and guides less experienced medical writers on complex projects.

Skills

Medical writing
Clinical documentation
Regulatory standards
Editorial reviews
Mentoring writers

Job description

Syneos Health, Inc. is seeking a Senior Medical Writer (FSP) with proven experience in clinical document writing, including protocols, CSRs, and IBs. The role emphasizes meeting regulatory standards while delivering high-quality documents on schedule.

The position supports remote work with flexibility across EST/CST time zones and involves collaboration with global teams to accelerate patient access to therapies.

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