Sr. Associate-Commercial Quality at Eli Lilly and Company

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Expertise in risk-based oversight strategy for affiliate programs
Ability to provide quality oversight to external parties (e.g., Call Center, PSP programs, Digital programs, BD programs, Market Access programs)
Knowledge of quality system processes and procedures for product complaints and commercial projects to comply with Lilly global standards and regulatory requirements
Capability to support internal audits and external inspections
Skills in developing and updating quality training materials
Experience driving continuous improvement in marketing/commercial programs and TPO oversight
Ability to establish and maintain relationships with business partners and stakeholders
Proficiency in complaint monitoring, trending, and SOP maintenance
Competence in periodic reconciliation of AE/PC events
Skills in PC metrics consolidation, data mining, and trending analysis
Ability to provide onsite/offsite quality oversight to third-party organizations
Expertise in leading/managing creation and revision of local complaint processes, procedures, and AEPC templates
Knowledge to collect complaint data and classify reports as PC, AE, combined PC&AE, or inquiry per Lilly criteria
Ability to confirm receipt of reports from third-party organizations

Responsibilities

Execute risk-based oversight strategy of affiliate programs set by quality compliance
Provide expertise and quality oversight to external parties of affiliate programs, including Call Center, PSP, Digital, BD, and Market Access programs
Liaise with quality compliance team to ensure programs are under centralized quality governance with appropriate oversight
Act as SME to maintain quality system processes and procedures for product complaints and commercial projects/initiatives
Support internal audits and external inspections
Develop and update quality training materials to improve customer awareness
Drive continuous improvement in processes for marketing/commercial programs and TPO oversight
Establish and maintain good relationships with business partners and stakeholders
Serve as China Affiliate RCP (Responsible Complaint Person) for Product Complaints
Conduct periodic reconciliation of AE/PC events with internal/external partners to ensure timely reporting and no missing cases
Develop and update PC-related training or documents (e.g., local TRD) to support business
Perform periodic PC metrics consolidation, data mining, and trending analysis to monitor post-launch trends
Provide onsite/offsite quality oversight (training, hidden checks, case follow-up) to third-party organizations
Lead/manage creation, revision of local complaint processes, procedures, and AEPC templates per global and local requirements
Collect complaint data and identify classification (PC, AE, combined, or inquiry)
Confirm receipt of reports from third-party organizations

Skills

Quality Oversight

Product Complaints

Risk Management

Affiliate Programs

Third-Party Organizations

TPO Management

Marketing Compliance

Commercial Programs

Quality Implementation

Call Center Oversight

PSP Programs

Digital Programs

Business Development

Market Access

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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