PMMS is an innovative, data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submissions. With a global presence across four continents and a 97% customer satisfaction rating, MMS has been recognized as a leading CRO in Global Health Pharma’s international awards for three consecutive years. For more information, visit our website or follow MMS on LinkedIn. /p pWe are seeking full-time consultants to join our extended team! /p h3Responsibilities /h3 ol liUnder minimal supervision, critically evaluate, analyze, and interpret medical literature to select primary resource materials ensuring study design, statistical significance, scientific rigor, and absence of bias. /li liWrite and edit clinical development documents, including protocols, investigator’s brochures, clinical study reports, consent forms, safety and efficacy summaries, presentation materials, and journal publications. /li liComplete writing assignments promptly, maintaining timelines and workflow. /li liProvide excellent internal and external customer service. /li liProficiently write regulatory documents according to various styles and client templates. /li liInteract directly with clients to coordinate project aspects, demonstrating strong communication skills. /li liContribute to or manage the production of interpretive guides. /li liTake ownership of assignments, consulting with team members and departments as needed. /li liMentor medical writers and project team members involved in writing processes. /li /ol h3Requirements /h3 ol liMinimum of 3 years of experience in the pharmaceutical industry. /li li3-5 years of regulatory and medical writing experience. /li liBachelor’s, Master’s, or Ph.D. in a scientific, medical, or clinical discipline. /li liSignificant experience as lead author on clinical study protocols. /li liExperience managing teams and authoring regulatory documents under tight deadlines. /li liExperience with regulatory submissions, such as clinical study reports, is advantageous. /li liUnderstanding of clinical data. /li liExceptional writing skills. /li liStrong organizational skills and multitasking ability. /li liExpertise in MS Word, Excel, PowerPoint. /li liExperience leading projects or managing teams. /li liKnowledge of federal regulations, GCP, and ICH guidelines is a plus. /li liExperience with orphan drug designations, PIPs, and PSPs is beneficial but not required. /li /ol pJ-18808-Ljbffr /p #J-18808-Ljbffr