From: nomesh.usithr@gmail.com   
      
   Hi ,,   
      
   Greetings for the day!   
      
   Hope you are doing Great!!   
      
   We have immediate requirements for below positions. Please go through the   
   descriptions and let me know if you are interested   
      
      
      
      
      
      
   Can be located in a Plymouth Meeting, PA or Cranford, NJ offices. right now   
   remote    
      
       
      
      
      
   Regulatory Affairs Senior Project/Program Manager   
      
       
      
   Position Description   
      
   Our client has an immediate need for business support in their Regulatory   
   function to support processing of Registration and Submission data from data   
   creation through Submissions Publishing / eCTD submission and archiving. The   
   client has recently    
   implemented a new global RIM and Publishing Platform (AMPLEXOR) and has   
   transitioned to a harmonized business process that represents a significant   
   change to how several legacy business units operated. The candidate would be   
   expected to collaborate with    
   client and third party resources to provide program and project execution   
   guidance, to track and drive progress of product submissions, and to assist in   
   remediating any change management / process adoption challenges.   
      
       
      
       
      
   Your future duties and responsibilities   
      
   Project/Program Management background to help organize, rationalize, and align   
   to an executable plan the set of disconnected activities currently being   
   carried out inside the regulatory group.   
      
   Key Areas of Responsibility would include:   
      
   • Establishing (or reinforce) the clients RACI and Data Management Model   
   with respect to Registration Data creation, ownership / stewardship,   
   consolidation, and publishing • Creating and maintaining Product / Therapy   
   Registration and Submission    
   Project Plans to include all major steps in the cycle (registration and   
   submission planning, document / artifact authoring/review/approval, submission   
   (eCTD) assembly, submission publishing, submission archiving), as well as   
   necessary support and    
   compliance activities (change controls, training & change management,   
      
   etc.)   
      
   • Driving process visibility via existing Amplexor System Reporting and   
   Trending Tools, as well as external Project Management Reporting and Tools •   
   Enforcing data standards and surveilling projects to identify and break down   
   any instances of siloed    
   or offline work such that the client can take full advantage of their   
   centralized RIM system   
      
       
      
       
      
   Required qualifications to be successful in this role Candidates must have   
   experience in regulatory affairs operations in a pharmaceutical environment,   
   and should have background in the following:   
      
   a. Submissions Planning and Registration Information Data Capture /   
   Stewardship b. Regulatory Document authoring, review, and approval c.   
   Submission Assembly (i.e. collecting Regulatory Documents and related data   
   sets and creating a Submissions Package    
   output, including experience with Electronic Common Technical Documents   
   [eCTD]) d. Submission Publishing e. Submission Archiving Must also have strong   
   organizational, communications and project mgmt. skills   
      
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