Senior Medical Writer - Remote Regulatory Documents Lead

Parexel

Lincoln (NE)

Remote

USD 75,000 - 110,000

Full time

14 days+

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Job summary

Parexel is seeking a Medical Writer in the United States to author and revise clinical documents for regulatory submissions. The role requires strong writing/editing skills, adherence to regulatory guidelines, and collaboration with cross-functional teams on project timelines.

Expertise in protocol development, reports, and CTD overviews is essential. The position emphasizes SOP compliance, literature reviews, and delivering high-quality content while supporting client needs and project

Qualifications

Extensive clinical/scientific writing skills with experience in regulatory documents.
Fluent English writing and editing for regulatory submissions.
Bachelor's degree in Life Sciences or Health-Related Sciences.

Responsibilities

Author clinical documents for regulatory submission (protocols, summaries, reports).
Revise drafts based on team comments and ensure SOP compliance.
Perform literature searches for background information as needed.
Review statistical plans for content appropriateness.
Lead project teams and coordinate interdepartmental reviews.
Provide medical editing review of drafts before distribution.
Maintain documents to publishing readiness and regulatory standards.