At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Post : Manager - Trial Capabilities and Regulatory
Job Description
• Ensure submission and approval of high-quality regulatory applications within planned timelines and Facilitate interactions with regulatory bodies on a regular basis for approvals.
• Initiate Investigator site(s) in collaboration with Asia-Pacific Trial Capabilities personnel, including monitoring of clinical trial regulations and requirements, providing consultation for effective communication with Competent Authority (CA) and relevant parties in addressing any validation questions on the clinical trial dossiers and resolving any barriers to approval.
• Ensure country specific regulatory and data privacy requirements are communicated to Asia Pacific Trial Capabilities personnel for incorporation into submission documents and any other documents/systems
• Ensure that Clinical trial activities comply with local regulations and quality system requirements whichever is more stringent.
• Anticipate and monitor dynamically changing regulatory requirements.
• Lead and Participate global Clinical system related projects
• Manage ERB/CA submission and site readiness activities involving distribute and collect hard-copy documents.
• Serve as the local point of contact for Trial Capabilities-related activities that have to be managed locally. The activities include, but not limited to meeting with site, ERB and CA for trial-related discussion; communicate with Site Engagement and external party / clinical research organization to enable active collaboration during site activation, maintenance and close-out
• Identify, communicate, and resolve issues
• Escalate issues to aligned management and quality as appropriate
• Coordinate the management and delivery of clinical trial material to ensure support of site initiation
• Populate internal systems to ensure accuracy of trial / site performance
• Populate Trial Master Files and libraries for future reference
• Anticipate and monitor dynamically changing priorities
• Understand, comply, and reinforce local regulations and guidances, Lilly Medical policies and procedures, and good clinical practices (GCP)
Candidate Profile
• Bachelor’s degree preferably in a scientific or health related field
• At least Two (2) years, previous clinical trial regulatory experience or relevant experience and preferred to be located or ready to re-locate in New Delhi region (NCR).
• Understanding of the overall clinical development paradigm and the importance of efficient site activation
• Applied knowledge of project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Effective communication, negotiation, and problem solving skills
• Self-management and organizational skills
• Language Capabilities – English (read, write, conversation) and local language, as applicable
Additional Information
Experience : Two (2) years
Qualification : Bachelor’s degree
Location : Gurgaon, Haryana
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Trial Capabilities and Regulatory
End Date : 10th December 2024
Apply Online
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts D.Pharm Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
