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Senior Medical Writer – EMEA (Client-Embedded) job at Thermo Fisher Scientific (PPD Clinical Research Services) | Apply Now
South Africa
Full Time
Are you looking for Medical jobs in South Africa 2025 today? then you might be interested in Senior Medical Writer – EMEA (Client-Embedded) job at Thermo Fisher Scientific (PPD Clinical Research Services)
About the Organisation
Thermo Fisher Scientific is a global leader in science and healthcare, dedicated to enabling customers to make the world healthier, cleaner, and safer. With over 100,000 employees worldwide, the company delivers innovative technologies, services, and solutions through its diverse portfolio. The PPD Clinical Research Services division provides contract research services in over 100 countries, supporting the development and delivery of life-changing therapies.
Job Title
Senior Medical Writer – EMEA (Client-Embedded) job at Thermo Fisher Scientific (PPD Clinical Research Services)
Thermo Fisher Scientific (PPD Clinical Research Services)
Job Description
This fully remote role offers the opportunity to be part of a dynamic and expanding medical writing team across the EMEA region. The Senior Medical Writer will develop a range of clinical and regulatory documents including study protocols, clinical study reports, investigator brochures, and submission packages. The writer will collaborate with cross-functional teams, ensuring accuracy, completeness, and compliance. The ideal candidate has experience with structured content authoring systems and automation technologies like Natural Language Generation, and preferably has worked with EU CTR (Clinical Trial Regulation) guidelines. Leadership, project management, and mentoring capabilities are essential in this senior-level position.
Duties, Roles and Responsibilities
Author and edit clinical and regulatory documents including protocols, CSRs, IBs, and regulatory submissions
Collaborate with cross-functional teams to gather and verify content
Ensure documents meet internal and external regulatory standards
Manage multiple writing projects and timelines
Review and provide feedback on peer documents
Present and advise on structure and content of documentation
Stay updated on industry standards, regulations, and trends
Contribute to mentoring junior writers and support team development
Qualifications, Education and Competencies
Education & Experience:
Bachelor’s degree in a scientific field required; advanced degree preferred
5+ years of regulatory medical writing experience in the pharmaceutical or CRO industry
Experience managing complex medical writing projects
Familiarity with EU Clinical Trial Regulation (EU CTR) preferred
Experience with structured content management systems and AI-driven content generation is a plus
Skills & Abilities:
Strong organizational and project management skills
Demonstrated leadership and mentoring abilities
Extensive knowledge of regulatory guidelines and drug development
Excellent interpersonal and communication skills
Detail-oriented with strong problem-solving abilities
High level of independence and sound judgment
How to Apply
ONLINE APPLICATION ONLY!
Interested candidates are advised that applications for this position must be submitted online. To apply please click the “Apply” button below.