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.

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 modules

Requirements:
• 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 skills