Trainee Retail Manager – Bloemfontein

Joblink Placement; Bloemfontein; On-site; ZAR 300,000 - 400,000; Full time

Job summary

An innovative firm in the pharmaceutical sector is seeking a Senior Medical Writer to join their dynamic team. This role offers the opportunity to work from home anywhere in South Africa, focusing on creating and editing critical clinical documents that meet rigorous regulatory standards. The ideal candidate will have substantial experience in medical writing, particularly in oncology, and will be responsible for managing writing assignments and mentoring junior writers. If you are a motivated self-starter with a passion for impactful medical communication, this position could be the perfect next step in your career.

Qualifications

• 3-5 years of regulatory and clinical medical writing experience required.
• Exceptional writing and organizational skills are essential.

Responsibilities

• Write and edit clinical development documents and maintain timelines.
• Critically evaluate medical literature for study design and statistical significance.

Skills

Medical Writing

Regulatory Writing

Clinical Study Protocols

Oncology Experience

Communication Skills

Organizational Skills

MS Word

MS Excel

MS PowerPoint

Education

Bachelor's Degree in Scientific Discipline

Master's Degree in Scientific Discipline

Ph.D. in Scientific Discipline

Tools

MS Word

MS Excel

MS PowerPoint

Job description

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, 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.

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 manage, 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, or 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.
• 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.