Senior Medical Writer (Home Based - South Africa)

Mms Holdings Inc.; Durban; Remote; ZAR 800 000 - 1 200 000; Full time

Job summary

A leading clinical research organization in South Africa is seeking a Senior Medical Writer. In this home-based role, you will manage writing regulatory documents, mentor team members, and contribute to clinical study protocols. The ideal candidate has over 5 years of experience in regulatory and clinical writing, exceptional writing skills, and a strong understanding of oncology. Join a supportive team where your contributions matter.

Qualifications

• At least 3 years of previous experience in the pharmaceutical industry.
• 5 years of regulatory writing and clinical medical writing experience.
• Substantial clinical study protocol experience, as lead author.

Responsibilities

• Communicate competitively for projects.
• Manage production of interpretive guides.
• Mentor medical writers involved in the writing process.

Skills

Regulatory writing

Oncology experience

Exceptional writing skills

Organizational skills

Project management

Education

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

Tools

MS Word

Excel

PowerPoint

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.

Senior Medical Writer

This position is a home-based role out of any location in South Africa.

Roles:

• Competitive 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

Qualifications:

• 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.