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Associate Director, Medical Compliance

Shanghai, China

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Req ID R-25790 Title Associate Director, Medical Compliance City Shanghai State / Province Shanghai Country China

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 35,000 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.

Purpose:

The purpose of this “Associate Director, Medical Compliance” role, is to 1) 1st level medical reviewer of promotion and educational materials of relevant brand, to ensure the approved promotional and educational material is compliant with local regulation, corporate policy; consistent with China Label and supported by  accurate medical and scientific information. 2)  SME of medical affairs related SOPs and compliance matters to support Medical Compliance Director; 3)   be delegated as final medical approver if needed. .

He/she should build and maintain relationship with key business partners (e.g.,Medical, Marketing, etc) and driving strong partnerships and alignment cross functional and TAs.

Responsibilities:  

SME of medical affairs related SOPs and compliance matters;

  • Support leader and serve as SME to improve the medical affairs related SOP and ensure the excellent execution.
  • Support leader and serve as SME to optimize the PEM related compliance governance and drive excellent execution
  • Be responsible for the training of medical affairs related policies and process
  • Facilitate timely review and approval of medical owned local policies and process

1st level medical reviewer of PEMs of relevant brands

Ensure the approved promotional and educational material is compliant with local regulation, corporate policy; consistent with China Label and supported by  accurate medical and scientific information. The medical reviewer should be:

  • Responsible for the medical accuracy and scientific nature of the promotional materials, including checking "data on file” and all other references;
  • Responsible for confirmation on whether the material is on-label;
  • Responsible for finalize the approval on time according to SOP requirement;
  • Expert of PEM related corporate policies;
  • Familiar with, and keep updated about relevant disease knowledge, product label and data.
  • Be responsible for review of other external used material (e.g. AB) generated from Medical

be delegated as final medical approver if needed.

Be accountable for the delegated PEMs are compliant with local regulation, corporate policy; consistent with China Label and supported by  accurate medical and scientific information. Including:

  • Medical accuracy and scientific nature of the promotional materials, including checking "data on file” and all other references;
  • Confirmation on whether the material is on-label;
  • Responsible for finalizing the approval on time according to SOP requirement;
  • Familiar with, and keep updated about all disease area knowledge, product label and data of Lilly portfolio in China

Minimum Qualification Requirements:

  • Medical training background with Master Degree
  • At least 8+ years of experience in pharmaceutical company
  • Broad functional expertise in pharmaceutical company in both medical and business perspectives.
  • Ability of driving decision marking 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:

  • Strong communication skills, both verbal and written
  • Strong knowledge of compliance and quality systems
  • Master above degree in health related field.   

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-25790.

Lilly is an EEO/Affirmative Action Employer and 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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