Team Lead (Publishing/ Regulatory Affairs)

  • Cognizant
  • Bridgewater, NJ, United States
  • Oct 11, 2017
Full time Accounting Admin-Clerical Banking Business Development Consultant

Job Description

Responsibilities:

 

  • Develops and mentors associates by providing expertise in all clinical electronic publishing submission types applicable to their region of responsibility.
  • Leads team of publishers (Sr. and Jr. Levels), manages people.
  • Coordinates and triages all submission publishing work activity to team
  • Provides input into client processes and software to Delivery manager for communication back to client.
  • Communicates issues and concerns to Delivery Lead proactively.
  • QCs work through spot checks on a regular basis.
  • Understands client expectations.
  • Main point of contact for client LRAs.

 

Skills Required:

  • Regulatory Affairs knowledge
  • Electronic Submission Publishing tools a must (eCTD, Insight) – at least 5-7 years’ experience in eCTD submission publishing.
  • Different submission procedures (US, Caribbean, South America & Canada )
  • Good Clinical Practice (GCP)
  • 21 CFR part 11
  • Excellent verbal & written communication
  • People Management experience, 3-5 years preferred
  • Ability to prioritize work
  • Excellent people management skills.

Qualifications:

  • Diploma/ Bachelor degree in Pharmacy, Life-Science
  • Minimum of 5 - 7 years in Regulatory Operations and Electronic Clinical Submission Publishing

 

Performance Standards:

Measurable

  • Establish work practices and procedures in the team.
  • Compliance with KPI’s
  • Customer satisfaction index

Non-Measurable

  • Self-motivation
  • Achievement building orientation
  • Relationship building ability
  • Inclination towards being process driven
  • Going out of way to satisfy the external customer
  • Punctuality (self-discipline)

 

 

Websitewww.cognizant.com/careers

Job Number: 00023623021