Remote Lead Medical Writer - Clinical Study Reports

Placements24; United States; Remoto; USD 120.000 - 160.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health, dental, vision insurance

Retirement savings plan

Fully remote work

Professional development opportunities

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Medical writing

Regulatory writing

Project leadership

CSRs

ICH E3 guidelines

Regulatory submissions

Remote collaboration

Formazione

Master's degree or PhD in life sciences

Strumenti

Document management systems

Descrizione del lavoro

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.