Senior Medical Writer (Project-Based) - Remote Job at MMS in Chicago

Senior Medical Writer (Project-Based) – Remote 4 weeks ago – Be among the first 25 applicants 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 decades of regulatory experience – that will assist our clients in developing and marketing life‑changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn. This role is a remote, project‑based consulting opportunity. Responsibilities Under minimal supervision, the Medical Writer critically evaluates, analyzes, and interprets medical literature to select primary resource materials ensuring adequate 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, integrated safety and efficacy summaries, Module 2.7.1–2.7.4, 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. Be highly proficient with writing styles for various regulatory documents. Expertly use client templates & style guides. Interact directly and independently with clients to coordinate all facets of projects; maintain competent communication skills. Contribute substantially to, or manage, the production of interpretive guides. Take ownership of assignments, proactively consulting other project team members and department representatives for information or guidance as necessary. Mentor medical writers and other members of the project team involved in the writing process. Requirements At least 3 years of previous experience in the pharmaceutical industry. 3–5 years of industry regulatory writing and clinical medical writing experience. Holder of a Bachelors, Masters, or Ph.D. in a scientific, medical, or clinical discipline. Substantial clinical study protocol experience as lead author. Experience leading and managing teams while authoring regulatory documents under 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 ability to multi‑task. Expertise in MS Word, Excel, PowerPoint, and related word‑processing tools. Experience as a project lead or managing a project team. Strong understanding of federal regulations, Good Clinical Practice, and ICH guidelines is a plus. Seniority level: Mid‑Senior level Employment type: Part‑time Job function: Information Technology Industries: Wireless Services, Telecommunications, and Communications Equipment Manufacturing #J-18808-Ljbffr