Remote Lead Medical Writer - Clinical Study Reports

Placements24; East London; Híbrido; ZAR 1.200.000 - 1.800.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Retirement plan

Remote work flexibility

Professional development

Descripción de la vacante

Placements24 is seeking a Lead Medical Writer with CSR expertise for a fully remote role with a global pharmaceutical client. You will lead planning, writing, and completion of CSRs and regulatory documents, guiding junior writers and ensuring regulatory compliance.

This senior position requires an advanced degree, 7+ years in medical writing, proficiency with ICH E3, and strong leadership. You will collaborate across clinical operations, biostatistics, regulatory affairs, and project

Formación

• Advanced degree in life/health sciences (Master's or PhD).
• Minimum 7 years of medical writing experience in pharma/biotech focusing on CSRs and regulatory documents.
• Expertise in writing complex CSRs per ICH E3 guidelines.
• Strong understanding of clinical trial design, conduct, data analysis and reporting.
• Excellent written and verbal communication with meticulous attention to grammar.
• Proven ability to manage multiple projects and meet deadlines in a remote setting.
• Strong collaboration and leadership skills.
• Proficiency with relevant software and document management systems.

Responsabilidades

• Lead the writing and finalization of CSRs, IBs, protocols, and other regulatory submissions.
• Ensure all deliverables are scientifically accurate, clear, and compliant with regulatory guidelines.
• Manage timelines and resources for medical writing projects to ensure timely delivery.
• Collaborate with cross-functional teams (clinical operations, biostatistics, regulatory affairs, PM).
• Review and edit documents written by junior writers and external vendors.
• Mentor junior writers and provide training to improve skills.
• Contribute to development and continuous improvement of writing processes and templates.
• Stay updated on regulatory requirements and scientific advances.

Conocimientos

CSR writing

Regulatory writing

ICH E3

Clinical trial design

Leadership

Educación

Master's or PhD in life/health sciences

Herramientas

Document management systems

Descripción del empleo

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.