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(Sr.) Manager, Medical Compliance

3-5 years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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

Job Title: (Sr.) Manager, Medical Compliance
Location: Shanghai, Shanghai, China
Category: Medical
Job Type: Full Time, Regular

About Us:
At Lilly, we unite caring with discovery to improve lives globally. As a leading healthcare company headquartered in Indianapolis, Indiana, our employees are committed to discovering, developing, and delivering life-changing medicines, improving disease management, and contributing to communities through philanthropy and volunteerism. We strive to make life better for people around the world.

Role Overview:
The (Sr.) Manager, Medical Compliance, is responsible for reviewing and ensuring that promotional and educational materials (PEMs) for relevant brands are in compliance with local regulations, corporate policies, and are scientifically accurate. This includes ensuring that materials are supported by accurate medical information and are aligned with product labels. Additionally, this role acts as an ambassador to help improve the quality of PEMs and optimize review processes.

Key Responsibilities:

  1. Medical Review of Promotional and Educational Materials (PEMs):

    • Ensure the medical accuracy and scientific nature of promotional and educational materials.
    • Review data on file and other references to ensure compliance.
    • Confirm whether the material is on-label.
    • Finalize approval of materials in accordance with Standard Operating Procedures (SOPs).
    • Stay informed and up-to-date on relevant disease knowledge, product labels, and scientific data.
  2. PEM Quality Improvement and Process Optimization:

    • Provide feedback to brand teams and material owners to enhance the quality of PEMs.
    • Actively contribute to the continuous improvement of the PEM review process.
    • Assist in educating and advising stakeholders on best practices for PEM compliance.

Requirements:

  • Educational Background:

    • Master’s degree in a medical or related field (e.g., pharmaceutical sciences, biology, etc.).
  • Experience:

    • At least 3-5 years of experience in the pharmaceutical industry, with a focus on medical compliance or related functions.
    • Broad functional expertise in medical or other relevant areas within the pharmaceutical industry.
  • Skills and Abilities:

    • Strong understanding of medical compliance regulations and policies.
    • Ability to drive decision-making processes and build relationships with internal and external stakeholders.
    • Excellent communication, interpersonal, organizational, and negotiation skills.
    • High level of compliance awareness and adherence to business integrity principles.

Additional Information:

  • Lilly is committed to providing accommodations for individuals with disabilities to support equal opportunities in the workforce.
  • Lilly is an Equal Employment Opportunity/Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender identity, sexual orientation, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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