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Publisher

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Our pharma client in Lake Forest, IL is looking for a Publisher to support the R&D team. This role is responsible for creating regulatory compliant report publications to be used in global regulatory submissions. These report publications are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency.

Responsibilities

  • Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidance. This includes verification of bookmarks, hypertext links and tables of content in global submissions.
  • Expedite, manage and coordinate a multitude of concurrent report publications in the development of published Global submissions within the required timelines.
  • Represent Medical Writing Operations on Global Project Teams or Submission teams as necessary, elevate timeline issues.
  • Act as publishing representative on cross-functional teams such as process improvement teams.
  • Create and finalize internal process and standards documents relating to publishing and publishing deliverables.
  • Assist in the implementation, testing, validation of software updates or enhancements.
  • Track metrics associated with submission publishing and rework.
  • Identify the possible impact of changes in regulations to the software and the business processes that support global submissions.
  • Remain current with Publisher and DocuBridge publishing tools based on individual plan developed by supervisor. 

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