Medical Writer - Pharmaceutical Dossiers

Placements24; LegKraal Gate; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Remote work

Home office support

Paid time off

Professional development

Job summary

Placements24 is seeking a skilled Medical Writer to craft regulatory documentation for submissions from a remote work environment near Mahikeng. You will translate complex clinical data into clear, compliant dossiers and collaborate with medical, clinical, and regulatory teams to ensure accuracy and completeness.

The role demands exceptional writing, deep regulatory knowledge, and the ability to work independently while coordinating with teams located nearby Mahikeng.

Qualifications

• Advanced degree in life sciences or related field.
• Minimum of 4 years experience as a Medical Writer.
• Experience preparing regulatory submission documents.

Responsibilities

• Write, edit, and review regulatory documents (IBs, CSRs, CTD modules).
• Ensure documents are scientifically accurate and compliant with ICH guidelines.
• Collaborate with SMEs to gather information and ensure integrity of documents.
• Manage development timelines and coordinate review cycles with stakeholders.
• Maintain high clarity, grammar, and consistency in all communications.
• Stay updated on regulatory requirements and best practices.

Skills

Medical writing

Regulatory documents

Editing

Regulatory guidelines

Education

Advanced degree (MS/PhD/PharmD/MD)

Tools

MS Word

Adobe Acrobat

EndNote

Job description

About the Role

Our client is seeking a skilled and precise Medical Writer to craft essential documentation for regulatory submissions from their remote work environment, supporting their teams near Mahikeng . This role is critical for translating complex scientific and clinical data into clear, concise, and compliant regulatory documents required for drug approval. You will work closely with cross-functional teams, including medical, clinical, and regulatory affairs, to ensure the accuracy and completeness of dossiers. The ideal candidate will possess exceptional writing abilities and a deep understanding of pharmaceutical development and regulatory processes.

Key Responsibilities

• Write, edit, and review various regulatory documents, including Investigator's Brochures (IBs), Clinical Study Reports (CSRs), Common Technical Document (CTD) modules, and briefing documents.
• Ensure all documents are scientifically accurate, ethically sound, and compliant with relevant regulatory guidelines (e.g., ICH).
• Collaborate with subject matter experts to gather necessary information and ensure the scientific integrity of documents.
• Manage document development timelines and coordinate review cycles with internal and external stakeholders.
• Maintain a high standard of clarity, grammar, and consistency in all written communications.
• Stay up-to-date with evolving regulatory requirements and medical writing best practices.

Requirements

• Advanced degree (M.S., Ph.D., Pharm.D., M.D.) in a life science, medical, or related field.
• Minimum of 4 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Demonstrated expertise in preparing various types of regulatory submission documents .
• Strong understanding of clinical trial processes, drug development, and global regulatory guidelines.
• Exceptional written communication, editing, and critical thinking skills.
• Ability to work independently in a remote setting while effectively collaborating with teams that may be located near Mahikeng .

Benefits

• Competitive salary and annual performance bonus.
• Comprehensive health, dental, and vision insurance.
• Flexible remote work arrangement with support for home office setup.
• Generous paid time off and holidays.
• Opportunities for professional development, including training and conference attendance.
• A collaborative and intellectually stimulating work environment.