At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Primary Responsibilities:

Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management

• Effectively create content strategy for writing projects.




• Plan, write, edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.




• Build scientific-based rationale that support the purpose of more complex and/or strategic documents.




• Coordinate expert/scientific reviews, adjust content of document as required based on internal/external input, and prepare final version.




• Influence and negotiate timelines and content with other team members.




• Partner with internal and external team members to develop and prepare presentations.




• Build and manage relationships with vendors/partners.

2.Project and Business Partner management

• Lead the writing process and apply effective project management skills to ensure completion of high-quality regulatory documents.




• Build/communicate credible writing project timelines.




• Anticipate and mitigate risks to delivery.




• Align with teams to ensure smooth development of documents.

3.Knowledge and Skills Development

• Therapeutic area knowledge including disease state and compound(s) for assigned project(s).




• Maintain and enhance knowledge of regulatory guidelines and publication guidelines.




• Possess strong knowledge of compound, therapeutic area, and external environment with ability to effectively influence submission strategy planning, customer regulatory responses, and awareness of literature updates and reviews.

4.Knowledge Sharing

• Recognized for technical expertise.




• Network with others (including other functions and regions) to identify and share best practices.




• Contribute to process improvements, suggesting opportunities where appropriate.

Minimum Qualification Requirements:

• Bachelor’s degree in a scientific, health, communications, technology health related field.




• Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)

Other Information/Additional Preferences:

• Strong communication and interpersonal skills.




• Demonstrated experience in technical/ regulatory scientific writing.




• Graduate degree with formal research component or in life sciences.




• Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields.




• Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise).




• Experience writing regulatory, clinical trial documents and/or publications




• Demonstrated ability to communicate and influence external strategies of business partners across different geographies and culture




• Ability to balance multiple activities, prioritize and manage ambiguity




• Demonstrated exemplary teamwork/interpersonal skills




• Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.