Job Description :
FTCTS_TL_123
Client: Direct client
Salary: $80K to 100K per annum
Team Lead (Publishing/ Regulatory Affairs)
Bridgewater, NJ
Full Time
100% On-Site
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)