Medical Writer

TransPerfect; Johannesburg; On-site; ZAR 600,000 - 800,000; Full time

Job summary

A leading company in the medical writing field is seeking a Regulatory Medical Writer to prepare high-quality regulatory documents. This role involves collaborating with teams, ensuring compliance with standards, and managing project timelines. Ideal candidates will have a Masters or PhD in a science discipline and 3-5 years of experience in medical writing. Excellent communication skills and a thorough understanding of regulatory guidelines are essential.

Qualifications

• 3-5 years of relevant industry experience in medical writing.
• Thorough understanding of ICH, GLP, GCP, GMP standards.

Responsibilities

• Provide medical writing support for ongoing projects.
• Manage project timelines and ensure compliance with regulatory standards.

Skills

Creative Thinking

Communication

Education

Masters or PhD in a science discipline

Tools

Word

PowerPoint

Excel

Outlook

Job description

The Regulatory Medical Writer collaborates with the Medical Writing team and clients to prepare high-quality regulatory documents, including Investigators Brochures, Safety Narratives, protocols, synopses, and more.

The role involves providing clinical regulatory document support and scientific writing expertise to ensure the successful preparation of submission-ready documents and the effective implementation of the writing process. The Regulatory Medical Writer also develops, implements, and maintains operations related to clinical trial registration and results disclosure.

This position ensures clear communication of technical information in scientific regulatory documentation. The role provides medical writing expertise for multiple compounds/projects within a therapeutic area, interfacing with external groups (e.g., PK, Toxicology, e-Submissions, Regulatory, Statistical Support, Data Management) and client teams to ensure accurate and timely document completion and review.

RESPONSIBILITIES

1. Provide medical writing support for ongoing projects, including preparing protocols, amendments, clinical study reports, and other regulatory documents.
2. Author clinical trial results disclosures on platforms like ClinicalTrials.gov, EudraCT, ENCEPP, including drafting, review, revision, quality control, approval, and publication.
3. Manage project timelines proactively, communicate relevant timelines, coordinate cross-functionally, meet deadlines, maintain document archives, and update tracking systems.
4. Ensure effective communication among team members, resolve conflicts, and help achieve project goals.
5. Follow applicable guidelines, templates, and SOPs, ensuring compliance with regulatory standards.
6. Perform quality checks for consistency between in-text information and source data.
7. Maintain knowledge of US, EU, and other international regulations, obtaining necessary certifications.
8. Act as Subject Matter Expert in eDocs, eCTD.
9. Develop, implement, and maintain operations related to clinical trial results disclosure throughout product development.
10. Recommend process improvements within the department and division.
11. Occasional international/domestic travel for conferences.
12. Perform additional tasks as assigned by management.

REQUIRED SKILLS, EXPERIENCE, AND QUALIFICATIONS

1. Masters or PhD in a science discipline (preferred), with certifications from AMWA, EMWA, or ISMPP.
2. Thorough understanding of ICH, GLP, GCP, GMP, and style guide standards.
3. 3-5 years of relevant industry experience in medical writing.
4. Creative, curious, diligent, and innovative thinker.
5. Client-facing with excellent communication skills.
6. Extensive knowledge of English grammar, spelling, and medical terminology.

DESIRED SKILLS, EXPERIENCE, AND QUALIFICATIONS

1. Experience with clinical publications or regulatory documents.
2. Ability to interpret scientific content.
3. Knowledge of statistical concepts.
4. Proficiency in Word, PowerPoint, Excel, Outlook, and scientific databases.
5. Experience working with cross-functional teams.