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

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