Associate, GSC Regulatory

Employment Type: Full time

Position Overview

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 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.

Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.

The purpose of the Associate, GSC Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to, protocols, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications).

Primary Responsibilities

1. 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.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Other Information/Additional Preferences

• This position is an Indianapolis-based role with the expectation of spending a minimum of 50% of the time in the office.
• Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process).
• Strong communication and interpersonal skills.
• Demonstrated experience in technical/ regulatory scientific writing.
• 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 the role.