Associate Director - Clinical Regulatory Scientist (Specialising in Pediatrics)

at  Lilly

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.
At Eli Lilly Cork, 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 41,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

PROVIDE INPUT TO CLINICAL PROGRAM TO SUPPORT MARKET DIFFERENTIATION NEEDS

• Communicate the regulatory options and impact on proposed product development plans, seeking Senior Regulatory Scientist and management alignment.
• Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets.
• Collaborate with PRA and VEO for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planning
  Support development and update of labeling strategy to deliver market differentiation

Initiate and update Claims Mapping, and Labeling Dashboard

• Partner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g., Claims mapping) and network for alignment. Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments. Use global labelling strategy to influence the drug development strategy, as needed.
• Create and communicate labeling dashboard to drive internal alignment on labeling strategy and key risks.

MINIMUM QUALIFICATION REQUIREMENTS:

• Bachelor’s degree in scientific or health sciences discipline
• Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5-8 years
• Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.