Remote Senior Medical Writer

Placements24; Bloemfontein; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Home office allowance

Professional development

Flexible hours

Job summary

Placements24 is seeking a Senior Medical Writer for a fully remote role. You will craft regulatory and scientific documents (CSRs, IBs, protocols) for pharmaceutical and biotech clients, collaborating with international teams while ensuring ICH-GCP compliance and high-quality output.

You will mentor junior writers, manage timelines, and contribute to templates, SOPs, and writing best practices in a remote setting.

Qualifications

• 5+ years in medical writing within CRO/pharma/biotech.
• Experience drafting CSR/IBs/protocols and regulatory submissions.
• Strong knowledge of ICH-GCP and regulatory processes.

Responsibilities

• Author, edit and review CSRs, IBs, protocols, and submission documents.
• Ensure documents are accurate, ethical and regulatory compliant.
• Collaborate with cross-functional teams to gather information and ensure accuracy.
• Manage document production timelines and on-time delivery of high-quality documents.
• Develop and maintain company templates, style guides and SOPs for medical writing.
• Stay updated with literature, therapies, and regulatory requirements.
• Mentor junior writers and review peers' work for quality and consistency.
• Participate in client meetings and contribute to documentation planning.

Skills

Medical writing

Regulatory writing

ICH-GCP

Documentation management

Strong communication

Education

Master's/PhD in Life Sciences/Medicine/Pharmacy

Tools

Document management systems

Job description

About the Role

Our client, a leading global Contract Research Organization (CRO) committed to advancing medical innovation, is seeking a dedicated and highly skilled Senior Medical Writer to join their fully remote team. This is an excellent opportunity to contribute to pivotal clinical research projects while enjoying the flexibility of working from home. You will be responsible for crafting clear, accurate, and compliant regulatory and scientific documents for a diverse range of pharmaceutical and biotechnology clients. This remote-first role requires a proactive approach, exceptional writing skills, and the ability to collaborate effectively with international project teams. Join us and play a key role in communicating critical research findings that impact global health.

Key Responsibilities

• Author, edit, and review a variety of clinical and regulatory documents, including Clinical Study Reports (CSRs), Investigator's Brochures (IBs), protocols, and regulatory submission documents.
• Ensure all documents are scientifically accurate, ethically sound, and compliant with applicable regulatory guidelines (e.g., ICH, FDA, EMA).
• Collaborate closely with project teams, including clinical investigators, statisticians, data managers, and regulatory affairs specialists, to gather information and ensure document accuracy.
• Manage document production timelines and ensure timely delivery of high-quality documents.
• Contribute to the development and maintenance of company templates, style guides, and standard operating procedures (SOPs) for medical writing.
• Stay up-to-date with relevant scientific literature, therapeutic areas, and regulatory requirements.
• Mentor and provide guidance to junior medical writers as needed.
• Review and critique documents authored by others to ensure quality and consistency.
• Participate in client meetings and contribute to the strategic planning of documentation requirements.

Requirements

• Master's or Ph.D. degree in Life Sciences, Pharmacy, Medicine, or a related field.
• A minimum of 5 years of experience in medical writing, preferably within a CRO, pharmaceutical company, or biotech environment.
• Proven expertise in writing complex clinical and regulatory documents for different phases of drug development.
• Thorough understanding of ICH-GCP guidelines, regulatory submission processes, and medical writing best practices.
• Exceptional written and verbal communication skills, with a keen eye for detail and accuracy.
• Strong analytical and critical thinking abilities, with the capacity to synthesize complex scientific information.
• Proficiency in using document management systems and other relevant software.
• Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines in a remote setting.
• Experience in various therapeutic areas is highly desirable.
• Must be legally authorized to work remotely in the designated region.

Benefits

Our client offers a competitive salary commensurate with experience, along with a comprehensive benefits package tailored for remote employees. This includes robust health, dental, and vision insurance, a retirement savings plan with company contributions, and generous paid time off. We also provide a home office allowance, opportunities for professional development, and flexible working hours. This is a unique chance to advance your career in medical writing with a leading organization, offering significant impact and work-life balance. Join our client's esteemed remote team and contribute to significant advancements in healthcare.