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.
We are the Global Pharmacokinetics/Pharmacodynamics (PK/PD) and Pharmacometrics Department at Lilly, and we’re looking for talent to join our newly formed Operational Team. We work with the goal of identifying the right dose of the right drug for the right patient and living the model-informed drug discovery and development (MIDD) paradigm. The PK/PD Operations Team will work to streamline, manage, and oversee departmental deliverables.
As a PK/PD Regulatory Activities Coordinator, you will be responsible for assisting with PKPD regulatory tasks related to the submission of medicines to global regulatory authorities. You will apply your knowledge of global regulatory guidelines, clinical trial data reporting (early and late phase), and PK/PD knowledge to advise and support PKPD scientists on required deliverables. You will work closely with PK/PD scientists and cross-functional teams to oversee key PK/PD deliverables, ensuring high quality and on-time delivery.
We seek dynamic, energetic, curious, and collaborative data scientists, project managers, or clinical operations specialists with a passion for operations, ready to engage and work on life-changing therapies for patients. We are passionate about making an impact in the lives of our patients and pushing the boundaries of science. Consider joining Team Lilly in Cork to contribute to Lilly’s drug discovery and development efforts.

Primary Responsibilities:

• Regulatory Expertise:
• Familiarity with global regulatory requirements for each region
• Advise PK/PD Scientists on requirements to support submission deliverables
• Assist on packaging submission deliverables and regulatory responses.
• Coordinate PK/PD deliverables with Global Regulatory Affairs Regulatory Scientists
• Develop critical product registration timelines and electronic submission structure and content requirements.
• PK/PD scientific and technical knowledge:
• Understanding of PK/PD analyses, data reporting and dataset requirements, and common technical documents for submissions.
• Collaborate with data management teams to ensure accurate collection, processing, delivery and analysis of PK/PD data, adhering to established standards.
• Contribute to process improvement initiatives to enhance efficiency, leveraging best practices, and innovative approaches.
• Collaborate with cross-functional teams to deliver submission documents.

Minimum Requirements:

• BSc in relevant scientific field, such as biological/pharmaceutical sciences, chemistry, engineering, statistics, data science or health-related discipline.
• Understanding of Pharmacokinetics/Pharmacodynamics principles
• Regulatory experience in a pharmaceutical or biotech setting

Additional skills/preferences criteria

• Knowledge of regulatory and compliance guidelines
• Understanding of clinical pharmacology (PK, PD and pharmacometrics) principles
• Knowledge of Clinical Quality work processes and GCP compliance
• Excellent organizational and time management skills.
• Proven ability to work independently and adapt to evolving priorities in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly 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.

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• Regulatory Expertise:
• Familiarity with global regulatory requirements for each region
• Advise PK/PD Scientists on requirements to support submission deliverables
• Assist on packaging submission deliverables and regulatory responses.
• Coordinate PK/PD deliverables with Global Regulatory Affairs Regulatory Scientists
• Develop critical product registration timelines and electronic submission structure and content requirements.
• PK/PD scientific and technical knowledge:
• Understanding of PK/PD analyses, data reporting and dataset requirements, and common technical documents for submissions.
• Collaborate with data management teams to ensure accurate collection, processing, delivery and analysis of PK/PD data, adhering to established standards.
• Contribute to process improvement initiatives to enhance efficiency, leveraging best practices, and innovative approaches.
• Collaborate with cross-functional teams to deliver submission documents