Senior Medical Writer (Remote)

About MMSMMS 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 is what 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.ResponsibilitiesUnder 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 biasWrite 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 journalsComplete writing assignments in a timely mannerMaintain timelines and workflow of writing assignmentsPractice good internal and external customer serviceHighly proficient with styles of writing for various regulatory documentsExpert proficiency with client templates & style guidesInteract directly and independently with client to coordinate all facets of projects; competent communicator skills for projectsContribute substantially to, or manages, production of interpretive guidesTake ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessaryMentor medical writers and other members of the project team who are involved in the writing processRequirementsAt least 3 years of previous experience in the pharmaceutical industryMust have at least 3-5 years of industry regulatory writing and clinical medical writing experienceThe ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical disciplineSubstantial clinical study protocol experience, as lead author, requiredExperience leading and managing teams while authoring regulatory documents with aggressive timelinesExperience in regulatory submissions (clinical study reports) presented to regulatory authorities a plusUnderstanding of clinical dataExceptional writing skills are a mustExcellent organizational skills and the ability to multi-task are essential prerequisitesCandidate must be an expert in MS Word, Excel, PowerPoint, and related word processing toolsExperience being a project lead, or managing a project teamStrong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plusNot required, but experience with orphan drug designations and PSP/PIPs a plus