Senior Medical Writer (Home Based - South Africa)

Mms Holdings Inc.; Pretoria; Remote; ZAR 600 000 - 900 000; Full time

Job summary

A clinical research organization is seeking a Senior Medical Writer to join their team in South Africa. This home-based position requires expertise in regulatory and clinical medical writing, as well as substantial oncology experience. The ideal candidate will hold an advanced degree and have a proven track record in leading project teams. Join a company that values innovation and collaboration in the field of clinical research.

Qualifications

• At least 3-5 years of industry regulatory writing and clinical medical writing experience.
• Substantial Oncology experience required.
• Experience leading and managing teams while authoring regulatory documents.

Responsibilities

• Mentor medical writers and other team members involved in the writing process.
• Take ownership of assignments and consult with team members as necessary.
• Contribute to, or manage, production of interpretive guides.

Skills

Excellent writing skills

Organizational skills

Project management

Communication skills

Education

Bachelor's, Master's, or Ph.D. in scientific, medical, or 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.

Visit or follow MMS on .

Senior Medical Writer We are recruiting for a Medical Writer to take on a vacant position in our South Africa team.

We are looking for a motivated self-starter, preferably with medical writing experience who is looking for a fresh challenge.

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

Roles 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 3-5 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.