Medical Writer - Clinical Documentation

Placements24; East London; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Home office stipend

Professional development opportunities

Generous paid time off

Remote collaboration tools

Job summary

Placements24 is seeking a highly skilled Medical Writer for a fully remote role based in the East London region. The candidate will craft clinical and regulatory documents, ensure regulatory compliance, and collaborate with cross-functional teams to ensure quality and timeliness of submissions.

The role requires 3–5 years of pharma/biotech writing experience, a life/health science degree (master's/PhD preferred), and strong ability to interpret complex clinical data while maintaining high

Qualifications

• Bachelor's degree in life or health sciences; master's/PhD preferred.
• 3–5 years of medical writing experience in pharma/biotech/CRO.
• Experience authoring CSRs, IBs, protocols.
• Strong knowledge of ICH guidelines and regulatory requirements.
• Excellent written and verbal communication and attention to detail.
• Ability to interpret complex data and present clearly.
• Experience working in a remote setting and managing multiple projects.

Responsibilities

• Author, edit, and review CSRs, IBs, protocols, and study summaries.
• Prepare regulatory submission documents (INDs, NDAs, CTD modules).
• Ensure documents meet ICH/FDA/EMA guidelines and SOPs.
• Collaborate with cross-functional teams to gather information.
• Manage timelines and deliverables in a remote setting.
• Perform literature searches and summarize scientific information.
• Maintain understanding of therapeutic areas and products.
• Contribute to medical writing processes and templates.
• Ensure style and scientific accuracy across documents.
• Review and provide feedback on others' documents.

Skills

Communication skills

Attention to detail

Time management

Team collaboration

Regulatory writing understanding

Education

Bachelor's degree in life/health sciences

Master's degree or PhD desirable

Tools

Word processing software

Electronic document management systems

Job description

About the Role

Our client, a globally recognized pharmaceutical organization, is seeking a highly skilled and experienced Medical Writer to join their expanding team. This role is essential for creating clear, accurate, and scientifically sound documentation required for clinical development, regulatory submissions, and publications. You will work collaboratively with scientists, clinicians, and regulatory professionals to ensure that all documentation meets the highest standards of quality and compliance. This position is fully remote, providing flexibility and the opportunity to contribute to critical medical writing projects from your home office. We are committed to fostering a productive and collaborative remote work environment, empowering our writers to excel. This is a vital role contributing to the advancement of healthcare through precise and comprehensive medical communication, based in the East London, Eastern Cape, ZA region.

Key Responsibilities

• Author, edit, and review a variety of clinical and regulatory documents, including Clinical Study Reports (CSRs), Investigator Brochures (IBs), protocols, and study summaries.
• Prepare and contribute to regulatory submission documents (e.g., Investigational New Drug applications (INDs), New Drug Applications (NDAs), Common Technical Document (CTD) modules).
• Ensure all documents are written in compliance with relevant guidelines (e.g., ICH, FDA, EMA), company SOPs, and industry best practices.
• Collaborate effectively with cross-functional teams, including clinical operations, biostatistics, regulatory affairs, and medical affairs, to gather necessary information and ensure accuracy.
• Manage timelines and project deliverables for assigned writing projects in a remote setting.
• Perform literature searches and summarize scientific information as required.
• Maintain a thorough understanding of the therapeutic areas and products assigned.
• Contribute to the development and improvement of medical writing processes and templates.
• Ensure consistency in style, tone, and scientific accuracy across all documents.
• Review and provide feedback on documents authored by others.

Requirements

• Bachelor's degree in a life science, health science, or related field.
• A Master's degree or PhD is a strong asset.
• Minimum of 3-5 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated expertise in authoring key clinical and regulatory documents (e.g., CSRs, IBs, protocols).
• Thorough understanding of ICH guidelines and regulatory requirements for clinical documentation.
• Excellent written and verbal communication skills, with exceptional attention to detail and grammatical accuracy.
• Ability to interpret complex scientific and clinical data and present it clearly and concisely.
• Proficiency in using word processing software and electronic document management systems.
• Proven ability to manage multiple projects, prioritize tasks, and meet strict deadlines in a remote work environment.
• Strong collaboration and interpersonal skills, with the ability to work effectively within a team.
• Familiarity with a specific therapeutic area is advantageous.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package.
• This fully remote position provides an excellent work-life balance and the autonomy to structure your workday effectively.
• Benefits include health, dental, and vision insurance.
• A retirement savings plan with company matching is available.
• Opportunities for professional development, including advanced medical writing training and conference attendance, are provided.
• Generous paid time off, including vacation, personal days, and holidays, is granted.
• A home office stipend and access to advanced remote collaboration tools are provided to ensure a productive and connected work experience for our team members, even when based remotely from East London, Eastern Cape, ZA.