Preferred Educational Qualification for the role: Bachelors degree in Life Science Preferred experience for the role: Minimum 5 Years Role: Team Leader Responsibilities:
Perform quality check (primary/secondary/PEER) in line with customer provided SOPs and checklist for Clinical and Safety Reports.
Leverage customer SOPs and perform quality check (primary/secondary/PEER) for submission readiness of References and prepare citations for inclusion under 'References' section of various types regulatory submission documents.
Handle transaction processing on need basis for time sensitive or critical to quality requests.
Provide extended support on need basis depending on customer/process requirement
Build effective and high performing team through integration motivation and optimizing team performance.
Provide support and allocate specific process tasks to each associate.
Provide/manage specific training to team members to ensure performance in their area of responsibility contribution to and participation within the team activities.
Coach and support associates to ensure performance is optimized in the process.
Develop and maintains effective working.
Manage the domain metrics and proactively identifies resource quality and timeline issues.
Escalate issues that would impact the process delivery to the appropriate level to ensure resolution and implementation of any corrective action plan.
Ensure quality of data by regular checks during the process.
Maintain awareness of internal and external regulatory activities.
Ensure the training of team members on updated / revised SOPs.
Provide expertise to Domain team on the technical aspects of the process as well as general ICH GCP.
Provide regular status reports to Project Manager.
Ensure adequate resource of the project throughout its lifecycle.
Participate in recruitment and selection process.
Monitor and track SLAs on a project basis.
Develop and maintain team training plan scheduling training for new team members.
Monitor performance of new/existing associates throughout the support provided to customer completing various action items.
Ensure access to all relevant systems and tools has been obtained for team members.
Employement Category:
Employement Type: Full timeIndustry: PharmaceuticalFunctional Area: Public RelationsRole Category: Quality Assurance - ManagerRole/Responsibilies: Document Publishing