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Project Manager - Safety Assessment Committee

Pennington, NJ

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Job DescriptionnPROJECT MANAGER - SAFETY ASSESSMENT COMMITTEE PENNINGTON / HOPEWELL, NJ Project Description: The Safety Assessment Committee manager is responsible for ensuring implementation of optimal operational strategies to evaluate anticipated events per FDA regulation. The manager will collaborate with internal partners (e.g. Medical Safety, Biostatistics, Epidemiology) and external partners (e.g. academic experts, global health authorities) to ensure the SAC conducts appropriate safety monitoring of anticipated events across all functional areas, and adherence to FDA requirements. tPartner strategically with the Safety Assessment committee chair to facilitate the development and execution of safety surveillance plans for assigned products. Ensure surveillance plan is aligned with TA portfolio objectives/strategiestDrive transparency of the safety assessment committee book of work, including decision making across different productstMaintain Safety surveillance plans and manage dependencies across functions and geographies (ie. US) and provide transparency to head of MSR and senior leaders. Prepare comprehensive project plans and progress reports for team leads, senior management and other stakeholderstIdentify risk areas or barriers that may or are impeding team success and work with teams, tPartner with Head of MSR to facilitate SAC meetings and ensure the agenda is focused on key deliverables, risk management, issue identification and resolution. Ensure that key actions and agreements are understood and the team is held accountable for their commitmentstIdentify, develop and implement new processes to facilitate continued evolution of the SAC function and improve efficiency tEnsure key communication points are captured and disseminated. Required Skills:tBS, with MBA, MS, PhD, PharmD or other advanced degree or equivalent experience preferred.tAdvanced project management skills and relevant experience on matrix management, budget management, metrics and senior leadership communication.tFive or more years of relevant industry experience (Medical Affairs, Development or Pharmacovigilance).tHighly organized and motivated individual possessing strong communication skills and ability to work effectively with cross functional teams.tExperience with drug development and reporting requirements. This 12 month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Karen: **** ALPHA'S REQUIREMENT #18-00811W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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