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 www.mmsholdings.com 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