Medical Writer

Placements24; Upington; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Fully remote work

Competitive salary

Health/dental/vision insurance

Professional development

Access to scientific literature

Job summary

Placements24 is seeking a talented Medical Writer to join its expanding medical affairs team. This is a fully remote position, enabling you to craft high-quality scientific and medical documents from anywhere.

You will develop CSRs, regulatory submissions, manuscripts, and educational materials while translating complex data into clear language. The role requires a life sciences degree (Bachelor’s or Master’s; PhD a plus) and at least 3 years of medical writing experience in pharma/biotech, with

Qualifications

• Bachelor's or Master's degree in life sciences; a PhD is a plus.
• Minimum of 3 years of experience as a medical writer in pharma/biotech.
• Strong understanding of regulatory guidelines (ICH, FDA, EMA).
• Excellent writing, editing and proofreading skills.
• Ability to interpret complex scientific data and present clearly.

Responsibilities

• Write, edit, and review medical documents with clarity and accuracy.
• Collaborate with cross-functional teams to ensure scientific accuracy.
• Develop CSRs in accordance with ICH guidelines and company standards.
• Prepare regulatory submissions such as IBs, INDs, and NDAs.
• Contribute to manuscripts and conference abstracts.
• Ensure materials comply with regulatory requirements and policies.

Skills

Medical writing

Editing

Regulatory knowledge

Scientific communication

Time management

Collaboration

Education

Bachelor's degree in life sciences

Master's degree in life sciences

PhD preferred

Job description

About the Role

Our client is seeking a talented and detail-oriented Medical Writer to join their expanding medical affairs team. This is a fully remote position, enabling you to craft high-quality scientific and medical documents from anywhere. You will be responsible for developing a wide range of documents, including clinical study reports, regulatory submission documents, manuscripts for publication, and educational materials. Your ability to translate complex scientific data into clear, accurate, and concise language will be essential. We are looking for a writer who is passionate about science communication and dedicated to maintaining the highest standards of scientific integrity.

Key Responsibilities

• Write, edit, and review various medical and scientific documents, ensuring clarity, accuracy, and adherence to style guidelines.
• Collaborate with cross-functional teams, including medical experts, statisticians, and regulatory affairs specialists, to gather information and ensure scientific accuracy.
• Develop clinical study reports (CSRs) in accordance with ICH guidelines and company standards.
• Prepare regulatory submission documents, such as Investigator's Brochures, Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Contribute to the development of manuscripts for peer-reviewed publications and abstracts for scientific conferences.
• Ensure all written materials are compliant with relevant regulatory requirements and company policies.

Requirements

• Bachelor's or Master's degree in a life science, medical, or related field; a PhD is a plus.
• Minimum of 3 years of experience as a medical writer, preferably within the pharmaceutical or biotechnology industry.
• Strong understanding of clinical research processes, regulatory guidelines (ICH, FDA, EMA), and scientific principles.
• Exceptional writing, editing, and proofreading skills, with a keen eye for detail.
• Ability to interpret complex scientific and clinical data and present it effectively.
• Excellent organizational and time management skills, crucial for managing multiple projects remotely.

Benefits

• Competitive annual salary and potential for project-based bonuses.
• Fully remote work arrangement, offering significant flexibility and autonomy.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and opportunities for professional development.
• Access to a wealth of scientific literature and resources.
• A supportive and collaborative virtual environment that values clear scientific communication.