Associate - Clinical Trial Registry Writing (Lilly - Bengaluru)
Location: Bangalore, Karnataka, India
Category: Research & Development
Type: Full-Time Regular
Job ID: R-81722
About Lilly:
At Lilly, we unite caring with discovery to make life better for people worldwide. Headquartered in Indianapolis, Indiana, we are a global healthcare leader dedicated to discovering and delivering life-changing medicines. Our employees worldwide are committed to improving disease management and giving back to communities through philanthropy and volunteerism. We strive for excellence and put people first, seeking individuals who are determined to make a positive impact globally.
Organization Overview:
The Associate, GSC Clinical Trial Registry (CTR) Writing supports the development and implementation of CTR systems and processes. This role ensures compliance with global transparency regulations and requirements while monitoring systems and metrics. The CTR writer collaborates with cross-functional teams across geographies and phases of drug development to ensure accurate and timely posting of clinical trial protocol information and study results.
Key Responsibilities:
Clinical Trial Registry and Results Management:
Contribute to developing, maintaining, and implementing policies and procedures on CTR and clinical trial results databases.
Identify studies for registry and results postings, ensuring timelines and deadlines are met.
Collaborate with cross-functional teams (e.g., biostatistics, medical, clinical trial management) to gather required data.
Manage access rights to applicable systems as needed.
Serve as a subject matter expert (SME) on CTR database requirements.
Develop and deliver internal education and training on CTR processes.
Define and monitor applicable metrics to ensure overall compliance.
Maintain and enhance knowledge of CTR regulations and guidelines.
Adapt to different therapeutic areas and compounds based on project assignments.
Project Management, Knowledge Sharing, and Process Improvement:
Support CTR systems and processes, ensuring consistent global practices.
Provide input for innovative solutions and process improvements.
Escalate issues in a timely and appropriate manner.
Monitor and evaluate CTR processes, communicating changes to the business.
Share key learnings to promote simplification and replicate best practices.
Basic Requirements:
Education:
Bachelor’s degree in scientific, health, communications, or technology-related fields.
Or, a Bachelor's degree in any field with at least two years of clinical development experience.
Technical Skills:
High-level end-user skills in MS Office applications (Word, Excel, PowerPoint).
Mastery of English language skills, both written and spoken.
Preferred Skills/Experience:
Experience with CTR processes and databases.
Experience in biostatistics, medical/regulatory writing.
Strong verbal reasoning, attention to detail, and analytical abilities.
Project management and time management skills.
Ability to work independently and within a team, taking initiative and completing tasks.
Flexibility to work in varying environments with multiple customer groups.
Strong interpersonal and negotiation skills with the ability to manage upwards.
Medical research background with a solid understanding of medical research processes across all phases of development.
Proven ability to influence cross-functionally and work across cultures and time zones.
Willingness to travel as required.
Diversity and Inclusion Statement:
Lilly is committed to fostering an inclusive workplace where all individuals are treated with dignity and respect. We provide equal opportunities for individuals with disabilities and encourage candidates who require accommodations to apply through the accommodation request form.
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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