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. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions rooted in strong science and regulatory experience to help clients develop and market life-changing therapies. MMS values enthusiasm, collaboration, and teamwork in a diverse, global talent pool. 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 Proficient with writing styles for various regulatory documents; expert with client templates & style guides Interact directly and independently with the client to coordinate all facets of projects; communicate effectively for project needs Contribute substantially to, or manage, production of interpretive guides Take ownership of a given assignment, proactively consulting other project team members and department representatives as needed Mentor medical writers and other project team members involved in the writing process Requirements At least 3 years of previous experience in the pharmaceutical industry At least 3–5 years of industry regulatory writing and clinical medical writing experience Bachelor’s, Master’s, or Ph.D. in scientific, medical, or clinical discipline Substantial clinical study protocol experience as lead author Experience leading and managing teams while authoring regulatory documents with aggressive timelines Experience in regulatory submissions (clinical study reports) presented to regulatory authorities is a plus Understanding of clinical data Exceptional writing skills Excellent organizational skills and the ability to multi-task Proficiency in MS Word, Excel, PowerPoint, and related tools Experience as a project lead or managing a project team Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus Not required, but experience with orphan drug designations and PSP/PIPs is a plus #J-18808-Ljbffr MMS
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