Sr. Publisher – Regulatory Affairs

US-NJ-Bridgewater
Job ID
2017-7401
Category
Information Technology

Overview

Our Client is a global leader in IT services, digital and business solutions that partners with its clients to simplify, strengthen and transform their businesses. Our Client has been recognized by Brand Finance as one of the Big 4 Global IT Services Brands, is looking for a Sr. Publisher - Regulatory Affairs for full time project in Bridgewater NJ, below is the detail requirement. 

 

"U.S. Citizens and those authorized to work in the U.S. are encouraged to apply. We are unable to sponsor at this time."

Responsibilities

  • Minimum 2-4 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, routine IND maintenance submissions, dossier management and dispatch of global drug dossiers (North America, Caribbean, Latin America, etc.)
  • Experience with electronic document management systems, submission publishing tools, knowledge of documents publishing/document management including, Adobe Acrobat.
  • Expert in HA (Health Authority) submission publishing requirements globally.
  • Good  in Regulatory Publishing to prepare the Clinical Documents (written by the Med. Writers) for submission through eCTD gateway
  • Strong understanding in Compiling and maintaining regulatory documents as per the procedure in client repository.
  • Experience in global regulatory submission / dossier publisher day-to-day activities and deliverables
  • Strong knowledge of regulatory processes and related tools (document management, publishing, etc.
  • Ability to be a mentor/trainer to Jr. Publishers

Qualifications

  • Bachelor's degree in Computer science or equivalent, with minimum 8 years of relevant experience.
  • Demonstrate excellent communication skills including the ability to effectively communicate with internal and external customers.
  • Ability to use strong industry knowledge to relate to customer needs and dissolve customer concerns and high level of focus and attention to detail.
  • Strong work ethic with good time management with ability to work with diverse teams and lead meetings.

  

Manoj

Lorven Technologies, Inc.

101 Morgan Lane | Suite 209 | Plainsboro | NJ 08536

Tel : 609-799-4202 X 223 | Fax:609-799-4204

Email: manoj@lorventech.com | Web: www.lorventech.com

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.