RHO

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Senior Regulatory Document Manager/Regulatory Document Manager II (electronic publishing)

Senior Regulatory Document Manager/Regulatory Document Manager II (electronic publishing)

ID 
2017-1321
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

Rho is seeking an experienced regulatory document manager proficient in electronic publishing and submission to FDA and other regulatory authorities. Experience with other document preparation and regulatory operations activities such as regulatory review of site essential documents or editorial quality review in general is also preferred.

Responsibilities

  • Collaborates with sponsors and internal team members to lead the preparation, assembly, submission, and maintenance of electronic and paper regulatory submissions in compliance with applicable regulations and sponsor specifications.
  • Publishes regulatory documents in accordance with eCTD standards and regulatory agency specifications.

  • Collaborates with sponsors and internal team members to avoid and address validation and technical specification issues.
  • Act as the technical contact for regulatory agencies.
  • Reviews essential regulatory documents according to Rho SOPs and sponsor specifications, ensuring accuracy and completeness

  • As needed, develops, writes, edits, formats, and performs quality control of a variety of regulated study documents including clinical study reports, protocols, annual reports, and other documents intended for inclusion in INDs, IDEs and NDAs.

Qualifications

  • Bachelor's required, Master’s degree a plus
  • Minimum of five (5) years’ experience in regulatory document and submission assembly and preparation, ideally in the electronic document publishing context.

  • At least two (2) years of this experience must be within a CRO or pharmaceutical company.
  • Advanced Microsoft Word, Excel, and Adobe Acrobat (including applicable electronic publishing plug-ins).
  • Familiarity with research processes and terminology.
  • Experience working on NDA submissions required.
  • Experience leading large submissions such as NDAs, BLAs or multiple INDs strongly preferred.
  • Experience with the Lorenz system is preferred.

 

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