Regulatory Content Creator

5 days ago

Newcastle, KwaZulu-Natal, South Africa MMS Holdings Inc. Full time

MMS Holdings Inc. is seeking a talented Medical Writer to join its team in South Africa. The chosen candidate will contribute to the creation of high-quality clinical development documents.

About MMS Holdings Inc.
  • We are a global CRO specializing in data-focused solutions.
Job Description
  • This is a remote position requiring minimal supervision.
Responsibilities
  • Evaluate and analyze medical literature to determine suitable study resources.
  • Develop and edit clinical development documents, including protocols, investigator's brochures, clinical study reports, and publications to medical journals.
  • Meet deadlines and maintain productivity.
  • Provide excellent internal and external customer service.
  • Demonstrate exceptional writing skills for regulatory documents.
  • Show expertise in client templates and style guides.
  • Collaborate with clients to coordinate project tasks and provide excellent communication.
  • Develop and manage interpretive guides.
  • Assume ownership of assigned tasks and consult colleagues when necessary.
  • Mentor junior writers within the team.
Requirements
  • A minimum of 3 years of pharmaceutical industry experience.
  • No less than 3-5 years of regulatory writing and clinical medical writing experience.
  • A degree in a scientific, medical, or clinical discipline.
  • Oncology experience is necessary.
  • Lead author experience in clinical study protocols is required.
  • Leadership experience in managing teams and meeting deadlines.
  • Submission experience for regulatory bodies is desirable.
  • Strong understanding of clinical data.
  • Superior writing skills are required.
  • Strong organizational skills and multitasking abilities.
  • Expertise in MS Office applications.
  • Project leadership experience.
  • Familiarity with federal regulations and ICH guidelines is beneficial.

Please note that we do not accept unsolicited resumes or inquiries.

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