Senior Quality Control Reviewer - South Africa (Project-Based, Remote)

MMS Holdings Inc; South Africa; Remote; ZAR 500 000 - 600 000; Full time

Job summary

A leading clinical research organization in South Africa seeks a Senior Quality Control Reviewer to ensure accuracy and consistency in regulatory documents. Ideal candidates will have at least 5 years of relevant experience and proficiency in MS Word and Excel. This project-based role offers an opportunity to contribute to impactful clinical research initiatives.

Qualifications

• Minimum of 5 years’ experience in Quality Control or similar field required.
• Clear and timely communication, able to work with others.
• Basic understanding of CROs and scientific & clinical data.

Responsibilities

• Ensure accuracy and consistency of a wide range of regulatory and medical communications documents.
• Conduct quality control reviews according to established procedures.
• Adapt documents to different regulatory and client standards.

Skills

Proficient with templates, toolbars, and macros

Able to adapt to different client styleguides and document formatting requirements

Proficient with correcting grammar & spelling errors

Proficient with ensuring scientific sense and correctness of data interpretation

Proficient with QC of regulatory documents

Education

College graduate in a scientific, medical, clinical discipline

Tools

MS Word

Excel

Job description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. This is a project-based opportunity up to 40 hours per week.

Senior Quality Control Reviewer

Job Specific Skills

• Proficient with templates, toolbars, and macros
• Able to adapt to different client styleguides and document formatting requirements
• Proficient with correcting grammar & spelling errors, with ensuring intra- and inter-document consistency
• Proficient with ensuring scientific sense and the correctness of data interpretation
• Proficient with the QC of a wide range of regulatory documents, including
  • Investigators Brochure
  • Protocols, protocol amendments and summaries of changes
  • ICFs and ICF amendments
  • CSRs (synoptic, abbreviated, interim, full, addendum)
  • Briefing Documents and Meeting Requests
  • Assessment Aids
  • Health Authority Responses
  • CTD clinical modules (especially strong experience with 2.7.1, 2.7.2, ISI)
• Additionally, proficient with the QC of a wide range of med comms documents would be advantageous but not necessary, including
  • Slide Decks
  • Posters
  • Abstracts
  • Manuscripts

Job Requirements

• College graduate in a scientific, medical, clinical discipline or related field is preferred, but relevant QC experience is acceptable
• Minimum of 5 years’ experience in Quality Control or similar field required.
• Proficiency with MSWord and Excel.
• Clear and timely communication, able to work with others to clearly understand needs and solve problems.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

Should you not have received a response within 14 days of your application, please consider your application unsuccessful.