- 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.
- 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.
- Diploma/ Bachelor degree in Pharmacy, Life-Science
- Minimum of 5 - 7 years in Regulatory Operations and Electronic Clinical Submission Publishing
- Establish work practices and procedures in the team.
- Compliance with KPI’s
- Customer satisfaction index
- Achievement building orientation
- Relationship building ability
- Inclination towards being process driven
- Going out of way to satisfy the external customer
- Punctuality (self-discipline)
Job Number: 00023623021