Lilly Associate Director, Medical Compliance in Shang Hai-上海, 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.
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.
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.
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!