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Senior Medical Writer

2 months ago

Pretoria, Gauteng, South Africa MMS Holdings Inc. Full time

About MMS Holdings Inc.

MMS Holdings Inc. is a leading Contract Research Organization (CRO) that provides innovative, data-focused solutions to the pharmaceutical, biotech, and medical device industries. With a proven scientific approach to complex trial data and regulatory submission challenges, MMS supports clients in creating compelling submissions that meet rigorous regulatory standards.

Job Summary

We are seeking a highly motivated and experienced Medical Writer to join our South Africa team. As a Medical Writer, you will be responsible for critically evaluating, analyzing, and interpreting medical literature to select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias.

Key Responsibilities

  • Write and edit clinical development documents, including clinical protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, and regulatory documents.
  • Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
  • Practice good internal and external customer service and interact directly and independently with clients to coordinate all facets of projects.
  • Mentor medical writers and other project team members involved in the writing process.

Requirements

  • At least 3 years of previous experience in the pharmaceutical industry.
  • Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience.
  • The ideal candidate would hold a Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
  • Substantial Oncology experience required.
  • Substantial clinical study protocol experience, as lead author, required.
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines.

What We Offer

MMS Holdings Inc. offers a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.