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Publisher (Regulatory Affairs)

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Our healthcare client is looking for a Publisher to create regulatory compliant submissions to be used in global regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency.

They will be responsible for:
- Performing 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 interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timelines.
- Represent Regulatory Operations Publishing 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.
- Prepare IND safety cover letters and IND amendment submissions to FDA.
- Remain current with Publisher University curriculum, based on individual plan developed by supervisor.

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