Clinical Trial Registry & Transparency Writer

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.

Purpose: The purpose of the Clinical Trial Registry (CTR) Writer is to support the development and implementation of Clinical Trial Registry (CTR) systems and processes, ensuring Global transparency regulations and requirements are implemented and monitored to ensure compliance. The CTR writer will collaborate with cross-functional, multidisciplinary teams across multiple geographies and phases of drug development to deliver accurate and on time postings of applicable clinical trial protocol information and study results.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

1. Clinical Trial Registry and Results Planning, Development, Finalization and Document Management

• Contribute to the development, maintenance, and implementation of policies and/or procedures on clinical trial registry and clinical trial results database processes and workflows. Find opportunities for process improvements.

• Identify studies required for registry and results postings. Ensure that responsible functions are aware of submission timelines.

• Collaborate cross functionally with applicable team members and departments (e.g., biostats, medical, clinical trial management), to obtain data required for completion of registry and results entries.

• Manage access rights to applicable systems as needed.

• Serves as subject matter expert on CTR database requirements.

• Develop and provide education and training as required to internal groups.

• Define and monitor applicable metrics to support overall compliance.

• Maintains and enhances knowledge of CTR regulations and guidelines.

• Exhibits flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc.

• Supports the systems and process for CTR and works with other team members to ensure consistent practices are followed globally.

• Provides input to deliver innovative solutions, preventing re-occurrence of issues.

• Raises issues efficiently as needed.

• Ensures the evaluation (monitoring) of the CTR processes and communicating changes to the processes to the business.

• Shares key learning to drive simplification and replicate standard processes.

Basic Qualification Requirements:

• Bachelor’s degree in scientific, health, communications, or technology related field

Or,

• Bachelor’s degree in any field with at least two years of clinical development experience.

Other Information/Additional Preferences:

• Experience with Clinical Trial Registry and Transparency processes and databases.

• Experience in biostatistics, medical/regulatory writing.

• Verbal reasoning, attention to detail, critical thinking, and analytical ability.

• Demonstrated project management and time management skills.

• Ability to be flexible in varying environments and with multiple customer groups.

• Able to work independently as well as part of a team: able to take initiative and responsibility, following through and completing assigned tasks.

• Able to deal with ambiguity and to plan, prioritize, and manage conflicting priorities.

• Experience working within multiple functional areas across medical, regulatory and legal.

• Strong interpersonal and negotiation skills - Ability to manage upwards.

• Strong medical research background with demonstrated breadth and depth of knowledge of medical research processes throughout all phases of development.

• Developed networks and proven ability to influence cross-functionally at all levels.

• Ability to work well across cultures and time zones.

• Willingness to travel as required.

• Strong communication and interpersonal skills.

This role is based in Indianapolis, IN.

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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About the Company:
Eli Lilly and Company