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.
Leadership
a. Responsible for study level clinical trial material on time delivery and QC sample on time shipment coordination which can include local clinical trials, regional participation in global trials, investigator initiated research, and expanded access programs etc.
b. Acts in conjunction with clinical development teams and Product Delivery personnel to develop study level strategy for and implement clinical trial material management activities for their region.
c. Act in conjunction with China and global CMC personnels to be responsible for monitoring project level QC sample on time shipment to China.
d. Contribute input on compound-level and trial-level strategic decisions as it relates to CT materials and as applicable to their region.
e. Identify and communicate with Product Delivery, CMC, Clinical Development, and the affiliate potential risks, limitations, and mitigation/contingency strategies (where appropriate) associated with study level CT materials supply and project level QC sample shipment.
f. Build relationships with internal and external partners and ensure robust communication with those partners them as it relates to study level CT materials and project level QC sample shipment and import/export.
e. Lead local sourced CT materials’ projection, managing inventory and supplies at both depot and site level.
Technical Expertise
a. Understand local sourcing, laws and regulations, and import/export rules for various supplies to China.
b. Understand commercial product sourcing strategies and processes for managing.
c. Apply knowledge of supply planning methodologies and expertise in supply chain principles to regional supply chain strategy and process improvement.
d. Support selecting and qualifying contract manufacturing organizations (CDMOs) with the needed capabilities, when required.
e. Provide technical oversight and in-country support for overseeing the study level contract manufacturing, packaging, labeling, and distribution activities, when needed, including batch record development and execution and shipping documentation preparation.
f. Contribute from trade compliance perspective, including importation/exportation activities, policies interpretation and liaison with authorities if necessary, but not limited.
Delivery
a. Responsible for the on-time delivery and management of the CT materials supply and related information from the initiation of study planning through approval of the final study report for their associated studies.
b. Responsible for the on-time shipment of QC sample and related information from shipment initiation till arrival to China.
c. Partner with a network of internal resources and third party contract organizations to execute development activities as it relates to CT supplies
d. Provide documentation to support importation, exportation, quality release of CT material and QC sample, as well as distribution activities of CT materials.
e. Ensure compliance with appropriate Lilly procedures, local regulatory requirements, and local laws in their region as it relates to clinical trial materials.
f. Aid in issue resolution as it relates to CT material delivery and QC sample import/export, shipment
g. Act as a point of contact for recalls and destruction of clinical trial materials which do not meet quality standards within region, as needed.
h. Provide appropriate escalation of issues and potential countermeasures to leaders, Product Delivery, CMC, RA and clinical teams.
Continuous Improvement
a. Understand performance metrics related to CT material and QC sample shipment for region and identify areas for improvement and simplification.
b. Understand SOPs and processes for CT materials are well understood across the affiliate(s), leading and providing clarification on local implementation.
c. Support the development of global SOPs and processes for CT materials and QC sample to maintain alignment with local laws and regulations
d. Responsible for solving study/project level technical and business issues of CT materials and QC samples related.
e. Continuously assess business processes for inefficiencies and improvement opportunities, identify action plans, and implement improvements.
f. Document the regional processes as it relates to CT materials/QC sample including the creation and update of procedures, tools, reference documents and process maps, as appropriate.
g. Document deviations to procedures, conduct root cause analyses, and leverage learnings to drive improvements and simplification.
h. Communicate process improvements, industry trends, new technologies, and new capabilities to stakeholders.
Minimum Qualification Requirements:
Bachelor’s degree preferably in a scientific or health-related field.More than 8 years of pharmaceutical development experience.Experience managing inventory/supplies or various complex supply chains, as well as experienced on handling import/export of chemicals, biomaterials and DG, but not limitedIn-depth knowledge of clinical research, clinical trial manufacturing, packaging and/or distribution, and interactive response systems (IRS).Ability to use and apply multiple computer applications, especially Excel and Microsoft Project.Demonstrated project management skills.Experience working and communicating with third party contract organizations.Fluent spoken and written English skills.Other Information/Additional Preferences:
Experience (5+ years) managing clinical trial materials, complex supply chains, and/or cross-functional projects.Advanced degree (Master, Doctorate, etc.) in operations management, supply chain, or a scientific fieldDegree, certification, or equivalent experience in project or supply chain management (i.e. APICS).Demonstrated ability to build and foster teamwork.Excellent interpersonal and organizational skills.Ability to influence at many levels and across disciplines, both internally and externally.Ability to manage multiple tasks and respond to changing priorities.High initiative, learning agility and a flexible, positive attitude.Strong quantitative skills and expertise.High degree of accuracy and attentive to details.Ability to proactively identify problems and work toward a solution.Demonstrated leadership and broad expertise within the clinical trial material services organization.Ability for international travel to support development and integration with global partners (up to 10%).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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