Scientific Communications Associate - Regulatory
Company Overview
At Lilly, we unite caring with discovery to improve lives worldwide. As a global healthcare leader headquartered in Indianapolis, Indiana, our mission is to discover and deliver life-changing medicines, enhance disease understanding, and give back to our communities. We prioritize our people and are looking for individuals who are committed to making a positive impact.
Purpose
Scientific data and information are core assets at Lilly. The Scientific Communications Associate - Regulatory will collaborate with cross-functional, multidisciplinary teams to develop documents for regulatory audiences, including protocols, protocol amendments, and informed consent forms (ICFs).
Primary Responsibilities
1. Content Strategy and Document Management
Collect and evaluate data from diverse sources to create a cohesive content strategy for writing projects.
Plan, write, edit, review, and finalize regulatory documents supporting clinical development and product registration.
Conduct effective initiation meetings to ensure alignment among authoring teams.
Develop scientific rationales for complex documents and ensure data is presented clearly and accurately.
Coordinate expert reviews, integrate feedback, and prepare final versions while ensuring quality checks for accuracy.
Adapt to multiple document types and negotiate timelines and content changes with team members.
Collaborate with internal and external experts to prepare presentations and manage vendor relationships as needed.
2. Project and Stakeholder Management
Lead the writing process and apply project management skills to ensure timely completion of high-quality regulatory documents.
Build and communicate credible project timelines, anticipating and mitigating delivery risks.
Collaborate with teams to ensure smooth document development and escalate issues as necessary.
Effectively communicate project status to stakeholders.
3. Knowledge and Skills Development
Enhance therapeutic area knowledge, including disease states and compounds for assigned projects.
Maintain familiarity with regulatory guidelines and adapt to different therapeutic areas as needed.
Stay informed about the external environment, including competitor activity, to effectively contribute to clinical planning and regulatory responses.
4. Knowledge Sharing
Provide coaching and share technical expertise with colleagues.
Network across functions to identify and share best practices and contribute to process improvements.
Offer expertise in document management systems and related tools.
Minimum Qualifications
Bachelor’s degree in a scientific, health, communications, or related field.
Demonstrated experience in technical or regulatory scientific writing.
Strong communication and interpersonal skills.
Successful completion of a writing exercise as part of the evaluation process.
Lilly is committed to fostering an inclusive workplace. If you require 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.
#WeAreLilly
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