Scientific Communications Associate - Regulatory
Company Overview
At Lilly, we unite caring with discovery to improve lives globally. As a leading healthcare company headquartered in Indianapolis, Indiana, our employees are dedicated to discovering and delivering life-changing medicines, enhancing disease understanding and management, and giving back to our communities through philanthropy and volunteerism. We prioritize people and are seeking individuals determined to make a positive impact.
Purpose
Scientific data and information are core assets at Lilly. The Scientific Communications Associate - Regulatory role is crucial for providing balanced, objective, and accurate information to regulators, the scientific community, healthcare professionals, payers, and patients throughout the drug development lifecycle.
Primary Responsibilities
Content Strategy and Execution
Collect and evaluate data from various sources to develop cohesive content strategies for regulatory documents.
Plan, write, edit, and finalize documents such as clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications.
Conduct initiation meetings to align authoring teams.
Build scientific rationales for complex documents and ensure clear, accurate presentation of data.
Coordinate expert reviews, integrate feedback, and prepare final versions while maintaining quality checks for accuracy.
Manage relationships with vendors and alliance partners as needed.
Project and Stakeholder Management
Lead the writing process, applying project management skills to ensure timely completion of high-quality regulatory documents.
Communicate credible timelines and anticipate risks to delivery.
Collaborate with teams to ensure smooth document development and escalate issues as necessary.
Knowledge and Skills Development
Maintain knowledge of therapeutic areas, regulatory guidelines, and publication standards.
Adapt to different document types and therapeutic areas as project needs change.
Enhance scientific communication skills to align with audience needs and technological advancements.
Knowledge Sharing
Coach others by sharing technical expertise and best practices.
Contribute to process improvements and provide expertise in document management systems.
Minimum Qualifications
Bachelor’s degree in a scientific, health, communications, or related field.
Experience in technical or regulatory scientific writing.
Strong communication and interpersonal skills.
Completion of a writing exercise as part of the evaluation process.
Additional Preferences
Graduate degree with a research component or in life sciences.
Expertise in clinical pharmacology or relevant therapeutic areas (e.g., neuroscience, oncology, cardiovascular, immunology, endocrine).
Experience in writing regulatory documents and understanding clinical development processes.
Proven project management and time management skills.
Proficiency in word processing, spreadsheets, and presentation software.
Lilly is committed to creating an inclusive workplace. If you need assistance submitting your application due to a disability, please fill out the accommodation request form here.
Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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