Regulatory Submissions Publisher/ Consultant

  • Price: Free
  • Published date: October 1, 2015 05:49
    • Parsippany, New Jersey, United States

Company Name:
Brilliant Leap, a div of Selective Search, Inc.



At Brilliant Leap we bring together superior Regulatory professionals with the finest Life Sciences companies on the planet.

We are currently searching for a Regulatory Submissions Publisher/ Consultant who has experience working with and a clear understanding of Regulatory Standards and FDA guidances.

You should be a team player, enjoy diversified responsibilities, and find satisfaction performing an exceptional job. We compensate those who have extraordinary abilities/experience extremely well.

Your main responsibilities will be 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.

- Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. 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 timeliness.


- Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.

Requirements

- 3-6 years regulatory submission experience and/or publishing experience using eCTDXPress or tools like it


- 3+ years in creation of global regulatory submissions that involved working with customers in planning and compilation of submissions.


- Expert in the use of publishing-related software tools including Documentum, eCTDXPress, ISI Toolbox, Adobe Acrobat. Thorough understanding of MS Word.
Project Management skills including good communication, negotiation and impact assessment.

If you qualify for this position, please send your resume and contact information to; Parsippany, New Jersey, United States; User's other ads

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