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Non Clinical Medical Writer

Company: MMS
Location: Canton
Posted on: February 24, 2021

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.Will participate in the development, writing, and management of Nonclinical-related documents.Roles and Responsibilities:* Strong experience with development and writing of Nonclinical-related documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator's Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents)* Lead projects independently with minimal oversight* Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data* Collaborate with cross-functional teams such as safety, biostats, CMC, and clinical* Demonstrated ability to lead others to complete complex projects* Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines* Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment* Organizational expert within the Nonclinical subject area* Excellent written/oral communication and strong time and project management skills* Ability to attend regular team meetings* Strong understanding of regulatory guidances as it applies to nonclinical submissions (eg, NDAs, MAAs, INDs, IMPDs)* Strong understanding of pharmacokinetics as it applies to nonclinical reports and nonclinical submission modulesRequirements:* BS + in biology or chemistry, or related field, with industry experience within regulatory affairs, laboratory sciences, quality assurance/control* Knowledge of GMP, ICH guidelines, and applicable regulatory requirements* 2+ years of pharmaceutical regulatory Nonclinical writing experience* Strong writing and analytical skillsPowered by JazzHR5OSJs314hW

Keywords: MMS, Canton , Non Clinical Medical Writer, Advertising , Canton, Michigan

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