Writer-Jobs in United States

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 an 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-leading 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.

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

• Under minimal supervision, critically evaluate, analyze, and interpret the medical literature to select primary resource materials for study design, statistical significance, scientific rigor, and absence of bias.
• Write and edit clinical development documents, including clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, safety and efficacy summaries, and publications for medical journals.
• Complete writing assignments in a timely manner and maintain workflow and timelines.
• Practice good internal and external customer service.
• Highly proficient with styles of writing for regulatory documents and familiar with client templates and style guides.
• Interact directly and independently with clients to coordinate project aspects; demonstrate competent communication skills.
• Contribute to or manage the production of interpretive guides.
• Take ownership of assignments, proactively consulting team members and departments as needed.
• Mentor medical writers and project team members involved in writing processes.

• At least 3 years of experience in the pharmaceutical industry.
• 3-5 years of industry regulatory and clinical medical writing experience.
• Degree in scientific, medical, or clinical discipline (Bachelor’s, Master’s, or Ph.D.).
• Substantial Oncology experience.
• Experience leading clinical study protocols as lead author.
• Experience managing teams and authoring regulatory documents under tight deadlines.
• Experience with regulatory submissions (clinical study reports) is a plus.
• Understanding of clinical data and exceptional writing skills.
• Excellent organizational skills and ability to multitask.
• Expertise in MS Word, Excel, PowerPoint, and related tools.
• Experience as a project lead or managing project teams.
• Knowledge of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
• Experience with orphan drug designations and PSP/PIPs is a plus.

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.