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Senior Medical Writer (Narratives)

Company: MMS Holdings Inc.
Location: Newark
Posted on: August 17, 2019

Job Description:

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience 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 was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.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, 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 processRequirementsMust be a Medical Writer who has written over 200 patient/CSR narratives in the last 3 yearsAt 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 disciplineExperience 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 plusx327B7Z7Gy

Keywords: MMS Holdings Inc., Newark , Senior Medical Writer (Narratives), Advertising , Newark, Delaware

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