Medical Writer

TransPerfect; Wes-Kaap; On-site; ZAR 400 000 - 600 000; Full time

Job summary

A leading company in the medical writing field is seeking a Regulatory Medical Writer. This role involves preparing high-quality regulatory documents and providing scientific writing expertise for clinical teams. The ideal candidate will have a strong background in medical writing and an understanding of international regulations.

Qualifications

• 3-5 years of relevant industry experience in medical writing.
• Certifications from AMWA, EMWA, or ISMPP preferred.

Responsibilities

• Provide overall medical writing support for ongoing projects.
• Author clinical trial results disclosures on platforms like ClinicalTrials.gov.
• Ensure effective communication among team members.

Skills

Communication

Creative Thinking

Attention to Detail

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, such as Investigators Brochures, Safety Narratives, protocols, synopses, and more.

This role provides clinical regulatory document support and scientific writing expertise to the clinical teams, ensuring the successful preparation of submission-ready documents and the effective implementation of the writing process. Additionally, the Regulatory Medical Writer is responsible for developing, implementing, and maintaining operations related to clinical trial registration and results disclosure.

The Regulatory Medical Writer ensures effective and clear communication of technical information in scientific regulatory documentation. The role involves providing medical writing expertise for multiple compounds and/or 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 delivery of documents.

Responsibilities

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

Required Skills, Experience, and Qualifications

1. Masters or PhD in a science discipline (preferred), along 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 written and oral communication skills.
6. Extensive knowledge of English grammar, spelling, and medical terminology.

Desired Skills, Experience, and Qualifications

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