Senior Scientific Document Reviewer (Home Based - South Africa)

MMS Holdings Inc; Remote; ZAR 600 000 - 800 000; Full time

Job summary

A leading clinical research organization is seeking a Scientific Document Reviewer for a full-time home-based role in South Africa. The ideal candidate has at least 5 years of Quality Control experience, proficiency in MS Word and Excel, and a strong understanding of scientific documents. Responsibilities include ensuring the correctness of various regulatory documents and adapting them to different style guides. Join us and contribute to shaping the future of clinical research.

Qualifications

• 5 years’ experience in Quality Control or similar field required.
• Clear and timely communication skills.
• Basic understanding of CROs and drug development process.

Responsibilities

• Review and correct regulatory documents for consistency and correctness.
• Adapt document formatting to specific style guides.
• Ensure scientific sense and data interpretation accuracy.

Skills

Proficient with templates, toolbars, and macros

Adapt to different client style guides

Correct grammar & spelling errors

Ensure scientific correctness

Quality Control of regulatory documents

Proficient with MS Word and Excel

Education

College graduate in scientific, medical, clinical discipline

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.

Scientific Document Reviewer

This position is a fulltime home-based role out of any locationin South Africa.

Job Specific Skills:

• Proficient with templates, toolbars, and macros
• Able to adapt to differentclient styleguides and document formatting requirements
• Proficient with correcting grammar & spelling errors, with ensuring intra- and inter-document consistency
• Proficient withensuring scientificsenseand the correctness ofdata interpretation
• Proficient withthe 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 withthe 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 fieldis preferred,butrelevant QCexperienceis acceptable
• Minimum of 5 years’ experience in Quality Control or similar field required.
• Proficiency with MSWord and Excel.
• Clear and timelycommunication, ableto work with others to clearly understand needs and solve problems.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

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