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Senior Medical Writer
2 months ago
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 Holdings Inc. supports clients in meeting rigorous regulatory standards.
Senior Medical Writer Role
We are seeking a highly motivated and experienced Medical Writer to join our team in South Africa. The ideal candidate will have a strong background in medical writing, with a focus on clinical development and regulatory submissions.
Key Responsibilities
- Under minimal supervision, critically 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 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.
- Contribute substantially to the production of interpretive guides and take ownership of assignments, proactively consulting other project team members and department representatives as necessary.
- 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 is required, as well as substantial clinical study protocol experience as lead author.
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines is essential.
- Exceptional writing skills, excellent organizational skills, and the ability to multi-task are must-haves.
- Candidates must be experts in MS Word, Excel, PowerPoint, and related word processing tools.
- Experience as a project lead or managing a project team is highly desirable.
- A strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
