At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Associate Director – LCDDMAC Medical Affairs Quality Control Lead is responsible for developing medical affair activities related risk assessment, mitigation plan and quality control strategy and oversight.  This role will lead, influence, drive and collaborate across functions to ensure that all the activities of the medical team including innovative approaches such as Grants, Quality improvement project, CWM scope school and so on are in compliant with current local laws, guidance, company policies and procedures to meet medical affair transformation and ARS targets.  This role will also be responsible for overall operational excellence of medical affair activities through process and systems creation/optimization and documentation. 

Primary Responsibilities:

Quality Control Strategy and Oversight of Medical Affair Activities

Leading cross function to set up risk assessment model, drive the related discussion and make the mitigation plan for overall medical affair activitiesLeading cross function to develop quality control and oversight plan for key medical affair activitiesResponsible of Audit Readiness for new and existing procedures and processes for Medical Affairs activities.Drive alignment between established standards / controlled documents and monitoring standards in partnership with cross functional business partners.Identify China environment, circumstance and requirements such as law, RADPAC code that impact Medical Affairs and partner with Ethics & Compliance teams to ensure programmatic updates and oversight.

  

Operational Excellence of Medical Affair Activities

Owner of Medical Affairs Guidance document that enables consistent execution across LCDDMAC.Deliver guidance and coaching across LCDDMAC on interpretations of Medical Affairs activities quality based upon monitoring observations.Give training or coaching to ensure that existing affiliate policies and procedures are reflective of Medical Affairs colleagues’ capability enablement.Provide quality oversight and monitoring inputs to enable Medical Affairs activities deliver with high integrity.

Medical Affairs Related SOPs and Compliance Matters

Partnering with the LCDDMAC leadership team and global Medical team to improve the medical affairs related SOP and ensure the excellent execution.Be accountable for the training of medical affairs owned policies and process, such as Advise board meeting, Scientific exchange meetings, etc.Be accountable for timely review and approval of medical owned local policies and processBe accountable for and centralize the interpretation of medical owned policies and process

Process and Systems Creation/Optimization and Documentation 

Working with across functional teams to create and update systems and coordinate support infrastructure for Medical Affairs activities.Generates and implements recommendations to optimize role-related processes. Consults on process changes and provides insight into possible areas of risk and opportunity. 

Minimum Qualification Requirements:

Master’s degree required.8 years industry experience.Medical affairs and/or Ethics & Compliance or Quality experience required, Lilly medical affairs experience is preferred.Ability of driving decision making process, build relationship, engage and influence key stakeholders, including external and internal ones.Ability of identifying solving complex business/operational problems and technical challenges.Strong compliance sense, diligent adherence to business integrity principles.Excellent communication, interpersonal, organizational and negotiation skills.Strong problem-solving skills: able to anticipate and recognize systemic problems, diagnose root causes and work with functional leadership to influence corrective actions that will prevent recurrence across multiple teams or functions.

Other Information/Additional Preferences:

Leadership, interpersonal skills, and ability to influence without authority.Demonstrated effectiveness in coaching and collaborating with others.Strong business acumen: ability to think strategically and problem solve.Team player who works well within a team construct and in complex environments to drive solutions.Demonstrated success in effective interpersonal and communication skills.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of 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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