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Nonclinical Medical Writer - Remote
Location:
Coatham Mundeville
Description:
MMS is an innovative, data-focused CRO that supports the medical, 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 in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit or follow MMS on Linked In. 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 e CTD 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. Visit ListedBuy for more information.
Company:
MMS
Posted:
January 2 on ListedBuy
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Nonclinical Medical Writer - Remote is a Other Art & Media Jobs Medical Writer Job at MMS located in United States. Find other listings like Nonclinical Medical Writer - Remote by searching Oodle for Other Art & Media Jobs Medical Writer Jobs.
Nonclinical Medical Writer - Remote is a Other Art & Media Jobs Medical Writer Job at MMS located in United States. Find other listings like Nonclinical Medical Writer - Remote by searching Oodle for Other Art & Media Jobs Medical Writer Jobs.