Offer summary

Qualifications:

At least 3-5 years of regulatory and clinical medical writing experience in the pharmaceutical industry., A Bachelor's, Master's, or Ph.D. in a scientific or medical discipline is preferred., Substantial experience in Oncology and clinical study protocol as a lead author is required., Exceptional writing and organizational skills, with proficiency in MS Word, Excel, and PowerPoint..

Key responsabilities:

Critically evaluate and interpret medical literature for study design and scientific rigor.

Write and edit various clinical development documents, ensuring compliance with regulatory standards.

Maintain timelines and workflow for writing assignments while providing excellent customer service.

Mentor junior medical writers and manage project teams to ensure successful completion of assignments.

Job description

About MMS

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 www.mmsholdings.com or follow MMS on LinkedIn.

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 & 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 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.

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