Associate Director - CIQ Global Medical Affairs at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor’s Degree - Preferred in a scientific or health science or related field
Minimum 5 years of quality assurance experience, medical affairs experience or related work experience
Capability to prioritize tasks, plan, and organize work
Ability to influence without authority
Demonstrated ability to effectively work with a cross-functional team to achieve desired outcomes
Advanced project management skills
Strong decision-making skills

Responsibilities

Serve as the process owner for key processes within Global Medical Affairs with a focus on continuous improvement and implementation of quality management core concepts
Lead and manage engagement with cross-functional teams to strategically define fit-for-purpose processes
Apply change management and risk management principles to proactively assure quality of Medical Affairs deliverables
Provide coaching and training to business partners to ensure adherence to requirements
Create and own the Medical Affairs Business Oversight Plan to enable new capabilities within the existing Quality infrastructure, in collaboration with Legal, Ethics & Compliance (E&C), and Quality teams
Ensure consistency and standardization related to the integration of new capabilities
Identify process performance issues and risks in collaboration with E&C and drive continuous improvement
Act as a subject matter expert for Global Medical Affairs on matters related to Quality
Oversee Audit Readiness for both new and established procedures and processes within Global Medical Affairs
Lead cross-functional teams to accelerate and deliver on MALT-approved proactive customer communication/interaction methods
Recognize and communicate potential obstacles that may hinder the implementation of proposed changes
Review and provide constructive feedback on procedures for clarity, feasibility, and risk management
Support the development of oversight plans, training programs, and change management
Deliver targeted quality improvements that can be implemented across global operations
Ensure that current policies and procedures incorporate new Medical Affairs capabilities across all channels, working closely with Ethics & Compliance
Develop and execute recommendations to enhance process efficiency
Advise on process modifications and offer insights into potential risks and opportunities

Skills

Key technologies and capabilities for this role

Quality Management SystemsProcess ImprovementChange ManagementRisk ManagementCross-Functional CollaborationTrainingCoachingMedical AffairsContinuous Improvement

Questions & Answers

Common questions about this position

What is the employment type for this position?

The position is full time.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What key skills are required for the Associate Director - CIQ Global Medical Affairs role?

The role requires expertise in quality management systems, process improvement, change management, risk management, cross-functional team leadership, coaching, training, and audit readiness.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, fosters continuous improvement, and emphasizes giving back through philanthropy and volunteerism.

What makes a strong candidate for this role?

Strong candidates will have experience serving as a process owner in quality management, leading cross-functional teams, applying change and risk management principles, and acting as a subject matter expert in audit readiness and compliance.

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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