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Nonclinical Medical Writing Consultant

Company: MMS
Location: Madison
Posted on: March 18, 2023

Job Description:

MMS 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 in -Global Health & Pharma's -international awards programs for the last three consecutive years. For more information, visit or follow MMS on .This role is a project-based consulting opportunity and 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 JazzHR

Keywords: MMS, Madison , Nonclinical Medical Writing Consultant, Advertising , Madison, Wisconsin

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