At Lilly, we unite caring with discovery to enhance lives worldwide. As a global healthcare leader based in Indianapolis, Indiana, our mission is to discover and deliver life-changing medicines while giving back to the communities we serve. We prioritize our employees and are looking for dedicated individuals eager to make a difference.
Purpose of the Role
Scientific data and information are core assets at Lilly. The Medical Affairs (MA) team plays a critical role in providing balanced, objective, and accurate information to regulators, healthcare professionals, payers, and patients throughout the drug development lifecycle. Our goal is to establish Lilly as the preferred pharmaceutical partner by leveraging our medical expertise to offer patient-centric solutions and insights.
Primary Responsibilities
As a Medical Affairs Content Development Specialist, you will be responsible for:
Content Strategy and Execution
- Document Preparation: Plan, write, edit, and finalize various regulatory documents supporting clinical development and product registration.
- Data Evaluation: Collect and assess data from diverse sources to create cohesive content strategies for writing projects.
- Collaborative Meetings: Conduct document initiation meetings to align the authoring team on project objectives.
- Scientific Rationale: Build scientifically sound rationales for complex documents, ensuring clarity and accuracy.
- Quality Assurance: Coordinate expert reviews, adjust content based on feedback, and ensure documents meet quality standards.
- Presentation Development: Work with internal and external experts to prepare presentations.
Project and Stakeholder Management
- Timelines: Lead the writing process, establish credible project timelines, and manage risks to ensure timely completion of high-quality documents.
- Stakeholder Communication: Effectively communicate project status to stakeholders and escalate issues when necessary.
Knowledge and Skills Development
- Therapeutic Area Knowledge: Stay informed about disease states and compounds related to assigned projects.
- Regulatory Guidelines: Maintain knowledge of relevant regulatory and publication guidelines.
- Scientific Communication: Enhance communication skills to align with audience needs and technological changes.
Knowledge Sharing
- Coaching and Guidance: Provide coaching to colleagues and share best practices across functions and regions.
- Process Improvement: Identify opportunities for process improvements and contribute to enhancing documentation tools.
Minimum Qualifications
- Education: Bachelor’s degree in a scientific, health, communications, or technology-related field.
- Experience: Demonstrated experience in technical or regulatory scientific writing.
- Skills: Strong communication and interpersonal abilities, along with project management skills.
