Associate Director – Copyright & Translations eCOA

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.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

The Associate Director-Copyright and Translation role is accountable for the final delivery of data collection instruments (English/Translations) used in clinical trials. The C/T associate director also provides guidance on linguistic validations, licensing requirements and contracting. This role is a key part of Lilly's Data and Analytics (DNA) organization's eCOA transformation efforts.

Portfolio Trial Support:

• Research scales and measurement of criteria needed for clinical trials.
• Perform quality review of documents to be provided to study teams.
• Version control of copyrighted and translated documents
• Identify issues that could impact the delivery of scales and questionnaires and implement risk mitigation plans.
• Coordinate financial requests to commission copyrights and/or translation work.
• Oversight of eCOA and copyright/translation vendor performance
• Proactively Identify risks and develop a mitigation plan.

Enterprise Leadership:

• Improving C/T processes to reduce cycle time and decrease work effort.
• Develop relationships with external copyright holders, help influence and mitigate licensing timeline risks to Lilly trials.
• Represent DnA processes in cross-functional initiatives.
• Work with vendor and copyright owners to increase vendor/partner efficiencies.
• Effectively apply knowledge of applicable internal, external, and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.)
• Bring external innovation by staying current with industry trends and regulatory policies.

Asset Protection:

• Understand the confidential nature of company information and takes necessary steps to ensure its protection. This includes understanding various aspects of Privacy as it relates to the data collected via DnA processes.
• Strive to maintain data integrity and inspection readiness to ensure the availability of data as evidence of compliance to regulatory requirements and to provide traceability.
• Ensure that an appropriate confidentiality agreement has been implemented before disclosing confidential company information to TPOs or other external partners.
• Accept obligation to Lilly for compliance to the integrity of the company.
• Maintain training compliance for all ethics and integrity focused training including Red Book.

Minimum qualifications:

• Master’s Degree in a scientific field with 3 or more  years’ experience in the pharmaceutical industry; or bachelor’s degree in a scientific field  with 7 or more years of experience in the pharmaceutical industry
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences:

• Experience with study development process and ERB submission requirements
• Clinical trial experience in a capacity such as Data Associate, Study Coordinator, CRA, etc.
• Understanding of the ISPOR requirements for linguistic validation of instruments
• Experience with electronic Clinical Outcome Assessment (eCOA) data and or development activities
• Understanding of FDA CFRs and GCP ICH Guidelines

- Domestic and International travel may be required.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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