MMS Holdings Inc. Medical Reviewer in Canton, Michigan

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience 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 was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit or follow MMS on LinkedIn.

Roles & Responsibilities

  • Provide significant expertise as primary medical reviewer of individual adverse event reports

  • Guide adverse event coding, retrieval and analysis activities in drug safety and clinical trials

  • Aggregate case analysis, safety summaries and safety signal generation

  • Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company

  • Prepare reports for submission to domestic and international regulatory agencies

  • Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations

  • Responsible for strategies in monitoring and analysis of cumulative safety information

  • Responsible for drug safety crisis management and risk management plans (RMPs)

  • Guide reviews of safety sections of NDA submissions

  • Guide regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, and periodic safety update reports (PSURs)

  • Guide and coordinate preparation of ad-hoc benefit-risk assessment documents

  • Plan cumulative safety information analysis such as signal detection from company or public databases with data mining

  • Guide safety updates of company core data sheet and local product labels

  • Guide regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees

  • Responsible for clinical writing

  • Interact with client matters related to changes and information required

  • Review blinded data tables for CSR writing

  • Address customer comments at each draft stage

  • Review documentation prior to release

  • Travel to client sites as necessary

  • Implement and validate QC findings as appropriate, in compliance with NC handling procedure

    Job Requirements

  • Medical degree required (or foreign equivalent)

  • 1+ years experience in technical or medical writing preferred

  • 1+ years of clinical experience and/ or research experience required

  • Excellent scientific writing skills

  • Ability to understand clinical data

  • Proficiency with MS Office applications

  • Good communication skills

  • Strong knowledge of current regulatory practices and domestic and international regulation