RHO Regulatory Document Manager (electronic publishing and technical editing) in Chapel Hill, North Carolina

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 preferred.

  • Collaborates with sponsors and internal team members to assure the preparation, assembly, submission, and maintenance of paper and electronic regulatory submissions in compliance with applicable regulations and sponsor specifications.

  • Publishes regulatory documents and groups of documents in accordance with eCTD standards and regulatory agency specifications.

  • 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 and NDAs.

  • BA/BS required, Master’s a plus

  • 2-3 years’ experience in regulatory document and submission assembly and preparation, ideally in the electronic document publishing context

  • 2-3 years’ experience in the Life Sciences; familiarity with research processes and terminology

  • Advanced MS Word, Excel, and Adobe Acrobat (including applicable electronic publishing plug-ins)

  • Experience with the Lorenz docuBridge system is preferred

EOE. Veterans/Disabled

If you are interested in applying, visit www.rhoworld.com

ID: 2017-1323

External Company Name: RHO