Remote Medical Writer - Pharmaceutical Documentation

Placements24; East London; Hybrid; ZAR 344,000 - 620,000; Full time

Benefits offered by this job

Fully remote

Flexible project-based workload

Job summary

Placements24 is seeking a skilled Remote Medical Writer to support regulatory submissions, CSRs, and CTD modules for a pharmaceutical/biotech client. The role is fully remote and contract-based, requiring 4+ years of medical writing experience and strong knowledge of ICH guidelines.

Ideal candidates will write clearly, edit rigorously, and collaborate with cross-functional teams while meeting tight deadlines in a remote setting. Flexible project-based workload offered.

Qualifications

• Bachelor's or Master's degree in a scientific or healthcare-related field.
• PhD is a plus.
• Minimum of 4 years of Medical Writer experience in pharma/biotech/CRO.
• Proven ability to write and edit complex scientific and regulatory documents.
• Thorough understanding of ICH guidelines and regulatory submissions.
• Exceptional written and verbal communication with keen attention to detail.
• Proficiency with document management systems and standard office software.
• Ability to work independently, manage multiple projects remotely.

Responsibilities

• Author, edit, and review medical and regulatory documents (CSRs, CTD modules, manuscripts).
• Ensure documents are accurate, clear, and compliant with ICH, FDA, EMA guidelines.
• Collaborate with clinicians, scientists, statisticians, and regulatory professionals to gather information.
• Manage document timelines and deliverables, ensuring timely completion of projects.
• Adhere to SOPs, templates, and style guides.
• Stay current with medical and regulatory developments and best practices.
• Contribute to development of writing processes and templates.
• Review and provide feedback on documents authored by others.

Skills

Exceptional written & verbal comms

Attention to detail

Ability to work independently

Time management

Education

Bachelor's or Master's in Life Sciences or related field

PhD is a plus

Tools

Document management systems

Microsoft Office

Job description

About the Role

Our client, a rapidly expanding pharmaceutical and biotechnology services company, is seeking a highly skilled and experienced Remote Medical Writer to contribute to their extensive documentation needs. This is a fully remote, contract-based position, offering flexibility and the opportunity to work on diverse projects within the pharmaceutical sector. You will be responsible for creating clear, accurate, and scientifically sound documents that support regulatory submissions, clinical trial reporting, and scientific communications. The ideal candidate will possess exceptional writing skills, a strong understanding of pharmaceutical development, and the ability to work independently to meet deadlines. Join a global team dedicated to accelerating drug development and improving patient outcomes.

Key Responsibilities

• Author, edit, and review a variety of medical and regulatory documents, including clinical study protocols, investigator brochures, clinical study reports (CSRs), common technical document (CTD) modules, and manuscripts.
• Ensure all documents are accurate, scientifically sound, clear, concise, and compliant with relevant guidelines (e.g., ICH, FDA, EMA).
• Collaborate effectively with cross-functional teams, including clinicians, scientists, statisticians, and regulatory professionals, to gather information and ensure document accuracy.
• Manage document timelines and deliverables, ensuring timely completion of projects.
• Adhere to company and client style guides, templates, and standard operating procedures (SOPs).
• Stay current with medical and scientific advancements, as well as regulatory requirements and industry best practices.
• Contribute to the development and refinement of medical writing processes and templates.
• Review and provide feedback on documents authored by other writers or team members.

Requirements

• Bachelor's or Master's degree in a scientific or healthcare-related field (e.g., Pharmacy, Life Sciences, English, Communications with scientific focus).
• A Ph.D. is a plus.
• Minimum of 4 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
• Proven ability to write and edit complex scientific and regulatory documents.
• Thorough understanding of ICH guidelines, regulatory submission requirements, and drug development processes.
• Exceptional written and verbal communication skills, with a keen eye for detail and grammatical accuracy.
• Proficiency with document management systems and standard office software.
• Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines in a remote setting.
• Strong collaboration and interpersonal skills to work effectively with diverse teams.

Benefits

This contract position offers a competitive hourly or project-based rate commensurate with experience. You will gain exposure to a wide range of exciting pharmaceutical projects and work with a global network of experts. This role provides the ultimate flexibility for a talented medical writer seeking to contribute their expertise remotely.