Remote Lead Medical Writer — CSRs & Regulatory Submissions

Placements24; United States; Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Retirement savings plan

Fully remote work

Professional development opportunities

Job summary

Placements24 is seeking a highly experienced Lead Medical Writer with CSR specialization. This fully remote role requires directing CSRs and regulatory documents, mentoring junior writers, and ensuring scientific accuracy and regulatory compliance.

Strong leadership and a deep understanding of clinical trial processes are essential. You will collaborate with cross-functional teams, manage multiple projects, and contribute to process improvements in medical writing workflows within a leading

Qualifications

• Advanced degree in life science or related field.
• Minimum 7 years of medical writing experience in pharma/biotech with CSR focus.
• Proven ability to produce CSRs in line with ICH E3.
• Excellent written and verbal communication with meticulous attention to detail.
• Ability to manage multiple projects and meet strict deadlines in a remote environment.
• Strong mentoring and leadership skills.
• Familiarity with regulatory guidelines and submissions process.

Responsibilities

• Lead writing and finalization of CSRs, IBs, protocols, and other regulatory submissions.
• Ensure all deliverables are scientifically accurate, clear, and regulatory compliant.
• Manage timelines and resources for medical writing projects.
• Collaborate with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and PM.
• Review and edit manuscripts from other writers and vendors.
• Mentor junior writers and provide training.
• Contribute to process improvements in medical writing templates and SOPs.
• Stay updated on regulatory requirements and scientific advances.

Skills

Medical writing

Regulatory writing

Project leadership

CSRs

ICH E3 guidelines

Regulatory submissions

Remote collaboration

Education

Master's degree or PhD in life sciences

Tools

Document management systems

Job description

Placements24 is seeking a highly experienced Lead Medical Writer with CSR specialization. This fully remote role requires directing CSRs and regulatory documents, mentoring junior writers, and ensuring scientific accuracy and regulatory compliance.

Strong leadership and a deep understanding of clinical trial processes are essential. You will collaborate with cross-functional teams, manage multiple projects, and contribute to process improvements in medical writing workflows within a leading