Clinical Trial Regulatory Specialist
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader based in Indianapolis, Indiana, we are committed to developing life-changing medicines, enhancing disease management, and giving back to our communities. We prioritize our people and seek individuals dedicated to making a meaningful impact.
Job Description
The Clinical Trial Regulatory Specialist plays a critical role in ensuring the timely submission and approval of high-quality regulatory applications. This position involves regular interactions with regulatory bodies and close collaboration with the Asia-Pacific Trial Capabilities team to navigate clinical trial regulations and requirements.
Key Responsibilities
Regulatory Applications: Ensure timely submission and approval of regulatory applications while facilitating interactions with regulatory bodies.
Site Initiation: Collaborate with Asia-Pacific Trial Capabilities personnel to initiate investigator sites and monitor compliance with clinical trial regulations.
Regulatory Compliance: Communicate country-specific regulatory and data privacy requirements for incorporation into submission documents.
Quality Assurance: Ensure compliance with local regulations and quality system requirements, monitoring dynamically changing regulatory landscapes.
Project Leadership: Lead and participate in global clinical system projects related to trial management.
Communication & Collaboration: Serve as the local point of contact for trial capabilities, facilitating meetings with sites, ethics review boards (ERBs), and competent authorities.
Issue Management: Identify, communicate, and resolve issues promptly, escalating to management as necessary.
Material Management: Coordinate the management and delivery of clinical trial materials to support site initiation.
Documentation: Populate internal systems and Trial Master Files to ensure accurate trial and site performance records.
Regulatory Guidance: Understand and reinforce compliance with local regulations, Lilly Medical policies, and good clinical practices (GCP).
Minimum Qualifications
Education: Bachelor’s degree in a scientific or health-related field.
Experience: At least two (2) years of previous clinical trial regulatory experience or relevant experience, preferably located in or willing to relocate to the New Delhi region (NCR).
Knowledge: Understanding of the clinical development paradigm and efficient site activation.
Project Management: Applied knowledge of project management processes.
Compliance Experience: Appreciation for compliance-driven environments.
Communication Skills: Effective negotiation, problem-solving, and communication abilities.
Organizational Skills: Strong self-management and organizational capabilities.
Language Proficiency: Proficient in English (reading, writing, and conversation) and the local language, as applicable.
Lilly is committed to fostering an inclusive workplace. If you require assistance submitting your application due to a disability, please complete the accommodation request form here for further assistance. This form is intended for accommodation requests only; other inquiries will not receive a response.
Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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