PMMS 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 inGlobal Health Pharma’sinternational awards programs for the last three consecutive years. For more information, visit or follow MMS on LinkedIn. /ppWe are looking for full time consultants interested in joining our extended team! /ppbResponsibilities /b /pulliUnder 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 /liliWrite 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, presentation materials and publications to medical journals /liliComplete writing assignments in a timely manner /liliMaintain timelines and workflow of writing assignments /liliPractice good internal and external customer service /liliHighly proficient with styles of writing for various regulatory documents /liliExpert proficiency with client templates style guides /liliInteract directly and independently with client to coordinate all facets of projects; competent communicator skills for projects /liliContribute substantially to, or manages, production of interpretive guides /liliTake ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary /liliMentor medical writers and other members of the project team who are involved in the writing process /li /ulpbRequirements /b /pulliAt least 3 years of previous experience in the pharmaceutical industry /liliMust have at least 3-5 years of industry regulatory writing and clinical medical writing experience /liliThe ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline /liliSubstantial clinical study protocol experience, as lead author, required /liliExperience leading and managing teams while authoring regulatory documents with aggressive timelines /liliExperience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus /liliUnderstanding of clinical data /liliExceptional writing skills are a must /liliExcellent organizational skills and the ability to multi-task are essential prerequisites /liliCandidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools /liliExperience being a project lead, or managing a project team /liliStrong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus /liliSubstantial clinical study protocol experience, as lead author, required /liliExperience leading and managing teams while authoring regulatory documents with aggressive timelines /liliNot required, but experience with orphan drug designations and PSP / PIPs a plus /li /ulpJ-18808-Ljbffr /p #J-18808-Ljbffr