Lilly is a global healthcare leader focused on combining care with discovery to improve the lives of people worldwide. Headquartered in Indianapolis, Indiana, Lilly develops life-changing medicines and engages in philanthropy and community service.

Role Purpose:

The Scientific Communications Associate – Regulatory leads the development of regulatory documents throughout the drug development lifecycle. This includes creating clinical study reports, regulatory responses, and submissions for regulatory approvals.

Key Responsibilities:

1. Content Strategy & Execution:
   • Collect, analyze, and synthesize data to create effective content strategies.
   • Develop, draft, and finalize regulatory documents.
   • Conduct initiation meetings for document alignment.
   • Build scientific rationale in documents, ensuring data accuracy and clarity.
   • Coordinate expert reviews and finalize documents post-feedback.
   • Oversee quality checks and manage multiple document types.
2. Project & Stakeholder Management:
   • Apply project management skills to ensure timely delivery.
   • Build and manage project timelines.
   • Anticipate risks and coordinate solutions.
   • Communicate project status effectively.
3. Knowledge & Skills Development:
   • Maintain therapeutic knowledge and stay updated on guidelines.
   • Exhibit adaptability across document types and therapeutic areas.
   • Participate in strategy planning and literature updates.
4. Knowledge Sharing:
   • Mentor and coach team members.
   • Share technical expertise and contribute to process improvements.

Qualifications:

Minimum Requirements:

• Bachelor’s degree in a scientific, health, communications, or related field.
• Experience in regulatory or scientific writing.
• Strong communication and interpersonal skills.
• Completion of a writing exercise during the selection process.

Preferred Qualifications:

• Advanced degree in life sciences or related field.
• Mastery of English in medical/scientific writing.
• Specific knowledge in clinical pharmacology or therapeutic areas (e.g., oncology, neuroscience).
• Experience in clinical development and regulatory documentation.
• Strong project and time management abilities.
• Advanced computer skills for document processing and data management.

Application Link