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Manager - Medical Affairs

3+ years
Not Disclosed
10 Dec. 26, 2024
Job Description
Job Type: Full Time Education: MBBS/MPH/MD/PharmD/PhD 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: Manager - Medical Affairs Quality
Location: LCCI, Bangalore
Company: Eli Lilly and Company


About Eli Lilly and Company

At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, we strive to bring life-changing medicines to those in need, improve the understanding and management of diseases, and give back to our communities. Our employees worldwide are committed to improving global health, and we're looking for individuals determined to make life better for people everywhere.


Position Overview:

The Manager - Medical Affairs is responsible for overseeing the lifecycle of promotional and medical deliverable reviews, ensuring compliance with Customer Information Quality (CIQ), Medical Content Approval (MCA), and Permission Managed Content (PMC) processes. This role involves leveraging content, project, and quality management tools to improve efficiency, while ensuring the timely and high-quality review and approval of materials. The Manager will also manage capacity planning, lead process improvements, and provide strategic leadership to the Medical Affairs Quality team.


Primary Responsibilities:

  1. Subject Matter Expert (SME):

    • Understand and apply Lilly’s medical and marketing tactics, quality standards, processes, and procedures.
    • Serve as an SME on internal systems and tools (e.g., Veeva, Global Vision, Wrike, AEM).
    • Lead deviation investigations and contribute to continuous process improvements.
  2. Deliverable Review Lifecycle Management:

    • Ensure that all materials comply with CIQ and MCA guidelines and are reviewed efficiently.
    • Manage project timelines, resourcing, and the agile needs of a changing portfolio.
    • Lead process and procedure updates to enhance efficiency and quality.
    • Conduct capacity planning, tracking, and reporting on team efficiency and productivity.
  3. Team Leadership and Development:

    • Manage and coach a team, including overseeing recruitment, onboarding, training, and performance evaluations.
    • Implement career development plans and provide guidance on succession planning.
    • Foster a collaborative, inclusive, and high-performance organizational culture.
    • Ensure team adherence to company policies and regulatory compliance.
  4. Process Optimization and Strategic Leadership:

    • Identify bottlenecks and recurring issues, and develop solutions to eliminate inefficiencies.
    • Collaborate across functions to establish best practices and share knowledge.
    • Drive data-driven decisions through business intelligence tools (e.g., Power BI, Tableau) and support reporting and analysis.
    • Contribute to the design and implementation of process changes, ensuring smooth execution.

Minimum Qualification Requirements:

  • 3+ years of experience in medical/marketing editing, copywriting, or proofreading in the pharmaceutical, communications, or agency environment.
  • 2+ years of management experience, with demonstrated leadership and strategic portfolio management.
  • Proven ability to lead teams, collaborate cross-functionally, and manage multiple priorities.
  • Strong experience in project management, decision-making, and problem-solving.
  • Experience working in regulated industries, particularly in the pharmaceutical sector.
  • Excellent written and verbal communication skills in English.

Educational Requirements:

  • Advanced degree (e.g., Master’s, MD, PharmD, PhD, MPH) in a relevant field.

Additional Preferences:

  • In-depth knowledge of the US CIQ/MCA procedures and tools such as Veeva, Global Vision, Wrike, and Adobe Experience Manager (AEM).
  • Experience with data analytics tools like Power BI and Tableau.
  • Experience in budgeting and capacity resourcing.

Other Information:

  • Location: LCCI, Bangalore
  • Minimal Travel (<10%)
  • Lilly is committed to providing equal opportunities to individuals with disabilities during the hiring process. For accommodations, please complete the accommodation request form here.

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.
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