Remote Lead Medical Writer - Clinical Study Reports

Placements24; Myrtle Beach (SC); Hybrid; USD 120,000 - 180,000; Full time

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.

Skills

Regulatory writing leadership

Project management

Editing and proofreading

Communication skills

Mentoring

Education

Master's or Ph.D. in life sciences

Tools

Document management systems

Regulatory submission software

ICH guidelines tools

Job description

About the Role

Our client, a prominent global pharmaceutical company, is actively seeking a highly experienced Lead Medical Writer with a specialization in Clinical Study Reports (CSRs). This position is fully remote, offering the flexibility to work from any location. You will be responsible for leading the planning, writing, and completion of comprehensive CSRs and other regulatory documents. This role requires exceptional writing skills, a deep understanding of clinical trial processes, and the ability to manage multiple complex projects simultaneously. As a Lead Medical Writer, you will mentor junior writers and ensure the highest standards of scientific accuracy, clarity, and compliance in all documentation produced. This is a key role in facilitating regulatory submissions and communicating clinical trial outcomes effectively.

Key Responsibilities

• Lead the writing and finalization of Clinical Study Reports (CSRs), Investigator Brochures (IBs), protocols, and other regulatory submission documents.
• Ensure all medical writing deliverables are scientifically accurate, clear, concise, and compliant with relevant regulatory guidelines (e.g., ICH E3).
• Manage timelines and resources for medical writing projects, ensuring timely delivery of high-quality documents.
• Collaborate closely with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and project management.
• Review and edit documents written by other medical writers and external vendors.
• Mentor and guide junior medical writers, providing training and feedback to enhance their skills.
• Contribute to the development and continuous improvement of medical writing processes and templates.
• Stay abreast of industry best practices, regulatory requirements, and scientific advancements relevant to medical writing.

Requirements

• Advanced degree (Master's or Ph.D.) in a life science, health science, or related field.
• Minimum of 7 years of experience in medical writing within the pharmaceutical or biotechnology industry, with a strong focus on CSRs and regulatory documents.
• Demonstrated expertise in writing complex clinical study reports according to ICH E3 guidelines.
• Excellent understanding of clinical trial design, conduct, data analysis, and reporting.
• Exceptional written and verbal communication skills, with a meticulous eye for detail and grammar.
• Proven ability to manage multiple projects, prioritize tasks, and meet strict deadlines in a remote environment.
• Strong collaboration and leadership skills.
• Proficiency with relevant software and document management systems.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, and a retirement savings plan. As a fully remote position, you will enjoy the flexibility and autonomy of working from home, with full support provided. Opportunities for professional development and career growth within a leading pharmaceutical organization are significant.