Remote Medical Writer (Oncology)

About the Role

Our client, a premier pharmaceutical company focused on innovative oncology treatments, is seeking a highly skilled and experienced Remote Medical Writer to join their dynamic medical affairs team. This is a fully remote position, offering the flexibility to work from anywhere in South Africa . You will be responsible for developing clear, accurate, and scientifically sound medical and regulatory documents. This includes drafting clinical study reports (CSRs), regulatory submission documents, manuscripts for publication, and educational materials, with a strong emphasis on oncology. The ideal candidate possesses exceptional writing skills, a deep understanding of oncology, and a thorough knowledge of regulatory guidelines and publication standards.

You will collaborate closely with cross-functional teams, including R&D, clinical operations, and regulatory affairs, to ensure the timely and high-quality production of essential documentation. This role is critical for communicating complex scientific and clinical information effectively to diverse audiences, including healthcare professionals, regulatory agencies, and patients. We are committed to advancing cancer research and value individuals who can contribute their expertise to this crucial mission.

Key Responsibilities

• Author and edit various medical documents, including CSRs, Investigator's Brochures (IBs), protocols, and regulatory submission documents (e.g., CTD modules).
• Develop manuscripts for peer-reviewed publications and abstracts for scientific conferences, focusing on oncology research.
• Prepare regulatory documents in compliance with FDA, EMA, and other global health authority requirements.
• Ensure scientific accuracy, clarity, consistency, and adherence to style guides and templates.
• Collaborate effectively with medical experts, scientists, and clinicians to gather information and refine content.
• Manage multiple document projects simultaneously, adhering to strict deadlines.
• Review and provide feedback on documents authored by others.
• Stay current with therapeutic area advancements (especially in oncology), industry trends, and regulatory guidelines.
• Ensure all documentation meets the highest standards of quality and compliance.
• Contribute to the development and maintenance of medical writing templates and style guides.

Requirements

• Advanced degree (Master's or Ph.D.) in a life science, medical, or related field.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry, with a significant focus on oncology.
• Proven experience in authoring CSRs, regulatory submission documents, and manuscripts.
• In-depth knowledge of oncology therapeutic area and current research trends.
• Thorough understanding of ICH-GCP guidelines and regulatory submission processes.
• Exceptional writing, editing, and proofreading skills, with a keen eye for detail.
• Ability to interpret and synthesize complex scientific and clinical data.
• Strong project management and organizational skills, with the ability to manage multiple priorities in a remote setting.
• Excellent interpersonal and communication skills for effective collaboration.
• Proficiency in Microsoft Office Suite and document management systems.

Benefits

• Our client offers a highly competitive salary, comprehensive health, dental, and vision insurance, a generous retirement plan, and performance-based incentives.
• We provide ample opportunities for professional growth, including access to specialized training, webinars, and virtual conferences.
• This remote position allows for significant flexibility and a healthy work-life balance.

Join our dedicated team in South Africa and make a tangible impact in the fight against cancer through clear and compelling scientific communication.