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Title Lead Clinical Data Sharing Associate- Home based
Job Locations -
US-PA-Blue Bell
Posted Date 3/6/2017
More information about this job:Overview:
  • Monitors US, EU and other international regulatory requirements, industry guidelines and societal expectations affecting clinical trial data sharing and communicates changes to functional leadership.
  • Provides oversight during the review, preparation and submission of clinical trial data sharing documents.
  • Manages vendor(s) for the conduct of clinical trial data sharing activities. 
  • Ensures quality assurance and quality control of vendor activities. 
  • Works cross-functionally to evolve global data sharing processes, procedures, systems and related training and communication
  • Completes the above in compliance with the applicable regulatory/Sponsor policies and requirements
  • Proposes and manages activities that support evolving strategy for clinical trial data sharing
  • Prioritizes activities and provides strategic input; anticipates and identifies potential issues and creates contingency plans
  • Represents Clinical Trial Data Sharing on internal and external work streams related to automation systems and other proposed changes that may impact policy related to clinical trial data sharing
  • Supports Sponsor in the development and implementation of redaction packages to support EMA Policy 70 and 43 and other document/data access regulations or publication requirements (as needed).
  • Trains and mentors more junior staff and develop job aids or update user guides as needed.
  • Works cross functionally to continuously improve processes, including adjustments to address external changes and evaluation of automation and tools to improve efficiency, accuracy and productivity.
  • Effectively communicates the purpose and requirements for clinical trial data sharing including roles and responsibilities.
  • May be asked to provide cross functional support across Global Medical Writing and Clinical Trial Data Transparency, if needed.
  • Acts as a Lead medical writer on several individual studies or other projects at a simple to complex level.
  • Acts as an individual medical writer on simple to moderate submissions projects.
  • Provides leads for Business Development opportunities. 
  • In addition to level 1 experience moderate science or medical related writing experience required
  • Advanced degree (M.S., PharmD, Ph.D.) preferred


PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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