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    Manager - Trial Capabilities And Regulatory

    Lilly
    5+ years
    Not Disclosed
    Gurgaon
    10 Nov. 19, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    At Lilly, we combine compassion with innovation to improve lives worldwide. Headquartered in Indianapolis, Indiana, we are a global leader in healthcare. Our dedicated employees strive to discover and deliver life-changing medicines, enhance disease management, and give back to communities through philanthropy and volunteer efforts. We are committed to putting people first and are seeking passionate individuals to help us make life better for people around the globe.

    Clinical Trial Responsibilities:

    • Lead the submission and approval of high-quality regulatory applications within set timelines and ensure consistent communication with regulatory bodies for approval processes.
    • Collaborate with Asia-Pacific Trial Capabilities personnel to initiate Investigator site(s), monitor clinical trial regulations, and facilitate effective communication with the Competent Authority (CA) to resolve any questions on clinical trial dossiers.
    • Communicate country-specific regulatory and data privacy requirements to ensure incorporation into submission documents and other relevant systems.
    • Ensure compliance with local regulations, quality system requirements, and good clinical practices (GCP).
    • Proactively manage evolving regulatory requirements and lead global clinical system-related projects.
    • Oversee ERB/CA submissions and site readiness activities, including coordinating the distribution and collection of hard-copy documents.
    • Serve as the local point of contact for trial-related activities, coordinating with Site Engagement, external parties, and clinical research organizations to enable efficient site activation, maintenance, and close-out.
    • Identify and address issues, escalating to management and quality teams when necessary.
    • Coordinate the management and delivery of clinical trial materials to support site initiation and populate internal systems to ensure accurate trial and site performance records.
    • Ensure proper maintenance of Trial Master Files and libraries for future reference.
    • Stay up-to-date with dynamic regulatory priorities and ensure compliance with local and global regulations and Lilly's medical policies.

    Minimum Qualification Requirements:

    • Bachelor’s degree in a scientific or health-related field.
    • At least two years of clinical trial regulatory experience or relevant experience.
    • Preferred to be located in or willing to relocate to the New Delhi region (NCR).
    • Strong understanding of clinical development, site activation, and regulatory compliance.
    • Knowledge of project management processes and the ability to navigate a compliance-driven environment.
    • Strong communication, negotiation, and problem-solving skills.
    • Ability to manage self and organize work efficiently.
    • Proficient in English and local languages as applicable.

    Lilly is committed to providing equal opportunities to individuals with disabilities and supports accommodation requests during the application process. Please complete the accommodation request form for further assistance.

    Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

    #WeAreLilly

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