Senior Medical Writer (Home Based - South Africa)

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. 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 www.mmsholdings.com or follow MMS on LinkedIn.Senior MedicalWriterWe are recruiting for aMedicalWriter to take on a vacant position in our South Africa team. We are looking for a motivated self-starter, preferably withmedicalwriting experience who is looking for a fresh challenge. This position is a home-based role out of any locationin South Africa.Roles & 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 Oncology experience requiredSubstantial 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 plusSubstantial clinical study protocol experience, as lead author, requiredExperience leading and managing teams while authoring regulatory documents with aggressive timelinesNot required, but experience with orphan drug designations and PSP/PIPs a plusPlease consider your application unsuccessful if we do not reach out to you within 14days of your submission.

#J-18808-Ljbffr Healthcare