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.

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 PharmacologyCommunicate and share scientific findings to authors/scientists and deliver nonclinical content with consistency, accuracy, and completenessMeet 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 benchmarksDevelop, implement, and maintain nonclinical timelines, aligning with the global organization submission timelinesLead and facilitate the discussion of nonclinical timelines and Table of Content (TOC)Coordinate submission document reviews, schedules, and host meetings to resolve team commentsWork with Global Scientific Communications (GSC) to ensure ADME method validation reports are included in the submission packetsLiaison with Japan Preclinical

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

Effectively collect and evaluate information from multiple sourcesPlan, write, and edit the nonclinical regulatory content and the IND documents, using the structured authoring styleEffectively communicate deliverables and corresponding writing processes, project timelines, and benchmarks to respective project leaders to ensure prompt development of documentsEnsure and coordinate quality checks for accuracy, check reviewer’s comments, adjust content of document as required based on internal input, and prepare final versionProactively identify and champion nonclinical writing process improvementsDrive 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 expertiseProven project management and time management skillsAbility to be flexible in adjusting quickly and effectively to frequent changes and altered prioritiesCognitive abilities including verbal reasoning, attention to detail, critical thinking, and analytical ability.Demonstrated effective teamwork skills with ability to adapt to diverse interpersonal stylesPrior 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 requestedTravel