Associate - Scientific Communications

Eli Lilly - Indianapolis, IN

Full-time - Entry Level

Indianapolis, IN

Chemical Manufacturing

About the position

The Associate Scientific Communications role at Lilly involves supporting the ADME, Toxicology, PK/PD division by ensuring the safety and efficacy of drugs through high-quality nonclinical submissions. The position focuses on data quality review, regulatory document preparation, and process improvements, requiring collaboration with scientists and project managers to meet strict deadlines and enhance submission processes.

Responsibilities

• 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.
• Partner with the Pharmaceutical Project Manager (PPM) to understand submission benchmarks.
• Develop, implement, and maintain nonclinical timelines, aligning with global submission timelines.
• Lead and facilitate discussions 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 submission packets.
• Liaison with Japan Preclinical.
• Effectively collect and evaluate information from multiple sources.
• Plan, write, and edit nonclinical regulatory content and IND documents using structured authoring style.
• Communicate deliverables and writing processes, project timelines, and benchmarks to project leaders.
• Ensure and coordinate quality checks for accuracy and prepare final versions of documents.
• Proactively identify and champion nonclinical writing process improvements.
• Drive shared findings of standard processes to peers and provide backup when needed.

Requirements

• Bachelor's Degree
• Proficiency in project management tools and techniques (e.g., Critical Chain, Veeva Vault, MS Project, etc.)
• Proven project management and time management skills
• Ability to adapt quickly 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.)

Nice-to-haves

• Actively seek to deepen scientific and regulatory knowledge through constant learning and identifying gaps in expertise

Benefits

• Health insurance
• 401k
• Paid holidays
• Professional development opportunities