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Organization Overview
The ADME, Toxicology, PK/PD, Laboratory for Experimental Medicine and Veterinary Resource (ATPLV) division within Lilly is accountable for ensuring the safety and efficacy of all drugs in the Lilly portfolio. As such, data / study documentation and regulatory reporting is a critical responsibility of the organization. The scientific communications representative (SCR), in conjunction with scientists, will provide support for ongoing projects to generate high quality on-time submission documents. The SCR will perform a myriad of Nonclinical data quality review activities, Nonclinical submission coordination for Marketing Applications, and provide document preparation, development, and management support across ATPLV. The SCR will support activities from both internal and external groups. Additionally, the SCR will drive process improvements by automating existing manual processes and lead in the development of new tools.

Are you ready to play a critical role in shaping nonclinical submissions that drive regulatory success and advance groundbreaking therapies? Join the Lilly team and bring your precision, collaboration, and scientific expertise to the forefront of innovation!

Responsibilities
The individual will support Nonclinical Data Quality Review Activities, including:

• Perform the review for nonclinical regulatory documents from Toxicology, ADME, and Pharmacology
• Communicate and share scientific findings to authors/scientists and deliver nonclinical content with consistency, accuracy, and completeness
• Meet strict deadlines and work in a team environment for large assignments

Nonclinical Submission Coordination for Marketing Applications will be completed through the following activities:

• Partner with the Pharmaceutical Project Manager (PPM)/Submission and Approval Expert Network's (SAEN) representative to understand submission benchmarks
• Develop, implement, and maintain nonclinical timelines, aligning with the global organization submission timelines
• Lead and facilitate the discussion of nonclinical timelines and Table of Content (TOC)
• Coordinate submission document reviews, schedules, and host meetings to resolve team comments
• Work with Global Scientific Communications (GSC) to ensure ADME method validation reports are included in the submission packets
• Liaison with Japan Preclinical

General Document Preparation, Development, and Management will also be supported.

• Effectively collect and evaluate information from multiple sources
• Plan, write, and edit the nonclinical regulatory content and the IND documents, using the structured authoring style
• Effectively communicate deliverables and corresponding writing processes, project timelines, and benchmarks to respective project leaders to ensure prompt development of documents
• Ensure and coordinate quality checks for accuracy, check reviewer’s comments, adjust content of document as required based on internal input, and prepare final version
• Proactively identify and champion nonclinical writing process improvements
• Drive shared findings of standard processes to peers and be a backup when needed

Finally, the individual would be required to aid in process improvements, including automation.

Basic Requirement
Bachelor's Degree

Additional Skills/Preferences

• Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva Vault, MS Project, etc.)
• Actively seek to deepen scientific and regulatory knowledge through constant learning and identifying gaps in expertise
• Proven project management and time management skills
• Ability to be flexible in adjusting quickly and effectively to frequent changes and altered priorities
• Cognitive abilities including verbal reasoning, attention to detail, critical thinking, and analytical ability.
• Demonstrated effective teamwork skills with ability to adapt to diverse interpersonal styles
• Prior technical writing experience within the biotech/pharmaceutical/clinical research organization (CRO)
• Proven ability to communicate with cross-functional teams (e.g. nonclinical, clinical, quality, regulatory, etc.)

Additional Information

• A writing test or examples of writing proficiency may be requested
• Travel <10%

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 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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