Remote Lead Medical Writer for CSRs & Regulatory Submissions

Placements24

Myrtle Beach (SC)

Hybrid

USD 120,000 - 180,000

Full time

6 days ago

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Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Remote work

Retirement plan

Job summary

Placements24 is seeking a Lead Medical Writer with expertise in Clinical Study Reports (CSRs) to lead writing and finalization of CSRs and regulatory documents. This fully remote role requires coordinating with cross-functional teams, planning timelines, and mentoring junior writers.

The ideal candidate has an advanced life-science degree, 7+ years in pharma/biotech medical writing, strong knowledge of ICH E3, and exceptional communication and project-management skills to ensure compliant,

Qualifications

Advanced degree in life or health sciences.
7+ years in medical writing in pharma/biotech with CSRs.
Deep knowledge of ICH E3 and trial reporting.
Excellent communication and attention to detail.

Responsibilities

Lead the writing and finalization of CSRs, IBs, protocols, and other regulatory submission documents.
Ensure all medical writing deliverables comply with ICH E3 and regulatory guidelines.
Manage timelines, budgets, and resources for medical writing projects.
Collaborate with cross-functional teams including clinical ops, biostatistics, regulatory affairs, and project management.
Review and edit documents written by other writers and external vendors; mentor junior writers.
Contribute to development and improvement of medical writing processes and templates.