Regulatory Project Manager

Create reports using ISI Publisher following standardized processes. 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. Review quality of published product to ensure compliance with regulatory standards including hypertext links, tables of contents and bookmarks verification. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Project Teams and/or 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. Create and finalize internal process and standards documents relating to publishing and publishing deliverables. Track metrics associated with submission publishing and rework. Prepare IND safety cover letters and IND amendment submissions to FDA.

SKILLS:

- Bachelor's degree preferred.
- 3-6 years submission experience and/or publishing experience.
- 3+ years in creation of global regulatory submissions that involved working with customers in planning and compilation of submissions.
- Thorough understanding of MS Word.
- Experience in working with multiple systems.
- Project Management skills including good communication, negotiation and impact assessment.
- Candidates must have experience with core submission and report publishing with extensive experience with eCTDXPress, Documentum, Adobe Acrobat, ISIPublisher and ISI Toolbox or a similar publishing software.
- Ability to juggle multiple concurrent publishing deliverables within scheduled timelines.
- Advanced word processing knowledge and experience using templates preferably ISIWriter.
- Hands-on experience with Document Management Systems preferably FirstDocs.
- Accurate and detail oriented.