Senior Medical Writer (Home Based – South Africa)

MMS; Umzimkhulu Local Municipality, Pretoria, Cape Town, Johannesburg; Remote; ZAR 600 000 - 800 000; Full time

Job summary

A leading clinical research organization is looking for a Senior Medical Writer to join their team in South Africa. This home-based position demands at least 5 years of clinical medical writing experience and strong proficiency in regulatory documentation. The ideal candidate is expected to evaluate medical literature, mentor writers, and manage writing assignments effectively. Great opportunities await for someone who is passionate about advancing their career in clinical research.

Qualifications

• Minimum 3 years of experience in the pharmaceutical industry.
• 5 years of industry regulatory and clinical medical writing experience.
• Experience in leading teams and drafting regulatory documents.

Responsibilities

• Evaluate and analyze medical literature for study design.
• Write and edit clinical development documents.
• Maintain timelines and manage writing workflow.
• Mentor medical writers in the writing process.

Skills

Exceptional writing skills

Strong understanding of federal regulations

Organizational skills

Proficiency in MS Word, Excel, PowerPoint

Leadership and team management

Education

Bachelors, Masters, or Ph.D. in scientific, medical, or clinical discipline

Job description

Are you looking to join a company where your contributions truly matter, and where you’ll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Senior Medical Writer

We are recruiting for a Medical Writer to join our South African team. This position is a home-based role out of any location in South Africa.

Roles & Responsibilities

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Requirements

• At least 3 years of previous experience in the pharmaceutical industry
• Must have at least 5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, 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
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
• Experience being a project lead, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Not required, but experience with orphan drug designations and PSP/PIPs a plus

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.