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.
- 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.