Senior Medical Writer (Home Based - South Africa)

Mms Holdings Inc.; Cape Town; On-site; ZAR 300,000 - 600,000; Full time

Job summary

An innovative company is seeking a Senior Medical Writer to join their dynamic team. This role involves crafting and editing clinical documents, ensuring adherence to regulatory standards, and mentoring fellow writers. With a focus on oncology and clinical studies, the position offers a unique opportunity for those passionate about the pharmaceutical industry. As a home-based role, you will engage directly with clients and contribute to impactful projects that shape the future of drug development. If you're a motivated self-starter with a knack for writing and a strong background in medical literature, this could be the perfect fit for you.

Qualifications

• 3-5 years of regulatory and clinical medical writing experience required.
• Expertise in MS Office tools and exceptional writing skills are essential.

Responsibilities

• Write and edit clinical development documents under minimal supervision.
• Mentor medical writers and manage project timelines effectively.

Skills

Regulatory Writing

Clinical Medical Writing

Exceptional Writing Skills

Organizational Skills

Communication Skills

Education

Bachelor's in Scientific Discipline

Master's 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 clients to coordinate all facets of projects; competent communication 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 a 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.