Clinical Development Document Specialist

1 month ago


Cape Town, Western Cape, South Africa MMS Holdings Inc. Full time

About MMS Holdings Inc.


MMS Holdings Inc. is a global Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with scientific expertise and innovative solutions to complex trial data and regulatory submission challenges.


We are looking for a highly skilled Clinical Development Document Specialist to join our team in South Africa. The ideal candidate will have extensive experience in regulatory writing and clinical medical writing, as well as exceptional writing skills and organizational abilities.


Job Description:



  • Evaluate, analyze, and interpret medical literature to select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias.
  • Write and edit clinical development documents, including protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, and presentation materials.
  • Meet tight deadlines and maintain timelines and workflow of writing assignments.
  • Provide excellent customer service and interact directly with clients to coordinate projects.
  • Mentor junior writers and contribute to the production of interpretive guides.

Requirements:



  • At least 3 years of experience in pharmaceutical industry regulatory writing and clinical medical writing.
  • Substantial oncology experience required, with a focus on clinical study protocol development.
  • Exceptional writing, organizational, and project management skills.
  • Proficiency in MS Word, Excel, PowerPoint, and related tools.
  • A strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.

The estimated salary range for this position is $80,000 - $110,000 per year, depending on qualifications and experience. We offer a competitive benefits package, opportunities for professional growth, and a dynamic work environment.


Please note that if we do not contact you within 14 days of your application, we regret to inform you that your application has been unsuccessful.



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