Lead Medical Writer in Clinical Research

2 months ago

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

About MMS Holdings Inc.

MMS Holdings Inc. is a pioneering, data-centric Contract Research Organization (CRO) that provides support to the pharmaceutical, biotechnology, and medical device sectors. Our proven scientific methodology addresses the complexities of trial data and regulatory submissions. With extensive industry expertise, technology-driven services, and a data-oriented approach to drug development, MMS stands out as a trusted partner, delivering compelling submissions that adhere to stringent regulatory requirements. Our global presence spans four continents, and we proudly maintain a 97 percent customer satisfaction rating. MMS has been recognized as a leading CRO in Global Health & Pharma's international awards for three consecutive years.

Senior Medical Writer

We are seeking a dedicated Medical Writer to fill a position within our South Africa team. The ideal candidate is a proactive self-starter with a background in medical writing, eager to embrace new challenges. This role offers the flexibility of being home-based from any location in South Africa.

Key Responsibilities

  • Conduct thorough evaluations and analyses of medical literature to identify primary resources essential for effective study design, ensuring statistical validity, scientific integrity, and neutrality.
  • Compose and refine clinical development documents, which include but are not limited to clinical protocols, investigator brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, and various regulatory documents.
  • Complete writing tasks within established deadlines.
  • Manage timelines and workflows associated with writing assignments.
  • Provide exemplary internal and external customer service.
  • Demonstrate high proficiency in writing styles applicable to diverse regulatory documents.
  • Exhibit expert knowledge of client templates and style guides.
  • Engage directly and independently with clients to oversee all aspects of projects, showcasing strong communication skills.
  • Contribute significantly to or oversee the creation of interpretive guides.
  • Take ownership of assigned tasks, proactively consulting with project team members and other departments for necessary information or guidance.
  • Mentor fellow medical writers and other project team members involved in the writing process.

Qualifications

  • Minimum of 3 years of experience in the pharmaceutical industry.
  • At least 3-5 years of experience in regulatory writing and clinical medical writing.
  • A Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline is preferred.
  • Significant experience in Oncology is required.
  • Proven experience as the lead author on clinical study protocols is essential.
  • Experience in leading and managing teams while producing regulatory documents under tight deadlines is necessary.
  • Familiarity with regulatory submissions, particularly clinical study reports presented to regulatory authorities, is advantageous.
  • Strong understanding of clinical data is essential.
  • Exceptional writing abilities are mandatory.
  • Excellent organizational skills and the capacity to manage multiple tasks are crucial.
  • Proficiency in MS Word, Excel, PowerPoint, and related software is required.
  • Experience in project leadership or team management is beneficial.
  • A solid understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
  • Not mandatory, but experience with orphan drug designations and PSP/PIPs is a bonus.

Please note that if you do not hear from us, your application has not been successful.

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