MMS
Job Description
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
www.mmsholdings.com
or follow MMS on LinkedIn.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 oversightInterpret and analyze applicable pharmacokinetics, pharmacology, and toxicology dataCollaborate with cross-functional teams such as safety, biostats, CMC, and clinicalDemonstrated ability to lead others to complete complex projectsAbility to complete documents according to sponsor’s format, processes, and according to regulatory guidelinesAbility to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgmentOrganizational expert within the Nonclinical subject areaExcellent written/oral communication and strong time and project management skillsAbility to attend regular team meetingsStrong 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/controlKnowledge of GMP, ICH guidelines, and applicable regulatory requirements2+ years of pharmaceutical regulatory Nonclinical writing experienceStrong writing and analytical skillsPowered by JazzHRCPlGa15ch3
#J-18808-Ljbffr
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
www.mmsholdings.com
or follow MMS on LinkedIn.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 oversightInterpret and analyze applicable pharmacokinetics, pharmacology, and toxicology dataCollaborate with cross-functional teams such as safety, biostats, CMC, and clinicalDemonstrated ability to lead others to complete complex projectsAbility to complete documents according to sponsor’s format, processes, and according to regulatory guidelinesAbility to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgmentOrganizational expert within the Nonclinical subject areaExcellent written/oral communication and strong time and project management skillsAbility to attend regular team meetingsStrong 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/controlKnowledge of GMP, ICH guidelines, and applicable regulatory requirements2+ years of pharmaceutical regulatory Nonclinical writing experienceStrong writing and analytical skillsPowered by JazzHRCPlGa15ch3
#J-18808-Ljbffr