Associate-Clinical Trial Registry Writer, Chorus
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 39,000 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 OF THE JOB:
The Associate, Clinical Trial Registry Writer will be supporting Chorus, a Division of Lilly Research Laboratories, which is a virtual development organization that manages a broad portfolio of New Molecular Entities from Candidate Selection through Clinical Proof of Concept. Chorus collaborates with a network of external experts to devise clinical strategy, design protocols, conduct experiments and provide data to inform development. Chorus seeks to conduct studies that have highest impact on probability of technical success in an efficient manner, while managing uncertainty and optimizing investment in secondary goals. The Chorus model seeks to advance molecules through the drug development cycle or enable clear termination decisions based on efficient proof-of-concept studies.
The purpose of the Chorus 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 described and implemented and that there are monitoring systems (and metrics) in place to ensure compliance for all assets in the Chorus portfolio. The Chorus CTR Writer will spend the majority of their time supporting the design, delivery, accuracy and maintenance of clinical information resources and databases ensuring compliance with global Clinical Trial Registry and other Global regulatory reporting databases in a timely manner.
CORE JOB TASKS:
Clinical Trial Registry and Results Planning, Development, Finalization and Document Management: Role-based Training Plan (Clinical Operations II)
- Contribute to the development, maintenance, and implementation of policies and/or procedures on clinical trial registry and clinical trial results database processes and associated workflows.
- Identify studies required for registry and results postings. Ensure that responsible functions are aware of associated timelines and deadlines.
- Maintain external focus by keeping abreast of emerging global industry posting and transparency requirements and provide guidance and training to CRCs and Chorus colleagues to ensure compliance and inspection readiness for molecules within Chorus portfolio.
- 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 result entries.
- Manage access rights to applicable systems as needed.
- Serve as the Chorus Subject Matter Expert regarding regulations and guidelines for posting within CT registries. In addition, provide interpretation, direct input into Quality systems, and influence Chorus direction to comply with external and internal expectation of posting study information.
- Develop and provide education and training as required to internal/external groups.
- Define and monitor applicable metrics to support overall compliance.
- Maintain and enhance knowledge of global CTR regulations and guidelines.
- Exhibit flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc.
- Complete and maintain the EU CTA application form within EudraCT as well as any subsequent information being entered into EudraCT during the products lifecycle.
- Maintain all information being entered CT.gov during the product’s lifecycle.
- Collaborate with teams internal and external to Chorus across multiple geographies and phases of drug development.
- Lead cross-functional clinical teams to create and maintain current clinical trial study information for Chorus and External Partner portfolio assets in compliance to global transparency standards for Registration and Results Reporting requirements.
- Inform and interpret changes in transparency requirements globally for Chorus.
- Communicate to management, teams, peers, and business partners to ensure compliance to reporting requirements. Knowledge/experience with writing Lay Summaries (i.e., Plain Language summary) and redacting information from regulatory documentation.
Project Management / Influence / Knowledge Sharing: Role-based Training Plan (Clinical Operations II)
- Supports the systems and process for CTR and works with other team members to ensure consistent practices are monitored and employed globally.
- Provides input to deliver innovative solutions, preventing re-occurrence of issues.
- Escalates issues in a timely and appropriate manner.
- 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 best practices.
MINIMUM JOB REQUIREMENTS (e.g., educational background, work history, etc.):
- 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.
- Demonstrated high-level end-user computer skills (MS office applications: Word, Excel, PowerPoint, etc.).
- Demonstrated mastery of English language skills written and spoken.
- Experience with CTR processes and databases.
- Experience in biostatistics, medical/regulatory writing.
- Experience with term and literature searches both internal and external to Lilly.
- 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 influence/lead others.
- Ability to work well across cultures and time zones.
- Willingness to travel as required.
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 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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-4366.
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.
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