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Job Description: Associate – Clinical Trial Registry Writing
Organization Overview
The Associate, GSC Clinical Trial Registry Writing plays a crucial role in ensuring compliance with global clinical trial transparency regulations. This position involves developing and implementing CTR systems, maintaining accurate clinical trial postings, and collaborating with cross-functional teams to meet regulatory requirements.
Key Responsibilities
1. Clinical Trial Registry & Results Management
- Develop and maintain policies and procedures for CTR compliance.
- Identify studies requiring registry and results postings, ensuring deadlines are met.
- Collaborate with biostats, medical, and clinical teams to gather necessary data.
- Serve as the subject matter expert on CTR database requirements.
- Provide training and education on CTR processes to internal teams.
- Monitor compliance metrics and implement process improvements.
- Stay updated on global CTR regulations and guidelines.
2. Project Management & Cross-Functional Collaboration
- Support global CTR systems for consistency and efficiency.
- Propose innovative solutions to prevent recurring issues.
- Escalate challenges timely and effectively.
- Share best practices to streamline processes.
- Work across multiple therapeutic areas as needed.
Basic Qualifications
- Bachelor’s degree in Science, Health, Communications, or Technology.
- OR Bachelor’s degree in any field + 2 years of clinical development experience.
- Strong English proficiency (written & spoken).
- Advanced MS Office skills (Word, Excel, PowerPoint).
Preferred Skills & Experience
- Experience with CTR processes and databases.
- Background in biostatistics, medical, or regulatory writing.
- Strong analytical, critical thinking, and project management skills.
- Ability to work independently and in teams, managing multiple priorities.
- Experience in medical, regulatory, or legal functions.
- Strong interpersonal and negotiation skills.
- Willingness to travel occasionally.
How to Apply
