Sr. Director - Global Regulatory Scientist - Early Clinical Development
دوام كامل
في eli lilly and company
في
Ireland
نُشرت يوم May 8, 2024
تفاصيل الوظيفة
Sr. Director - Global Regulatory Scientist – Early Clinical Development page is loaded
Sr. Director - Global Regulatory Scientist – Early Clinical Development
Apply locations Ireland, Cork time type Full time posted on Posted 4 Days Ago job requisition id R-62024 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. Lilly 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. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Responsibilities: The Sr. Director, Regulatory Scientist North America – Early Clinical Development serves as the regulatory regional lead for assigned molecules in development. As the regulatory lead, the Sr. Director will be responsible for driving the regulatory strategy for development in the US and Canada from discovery through the start of registration studies. The Sr. Director will also partner with other global regulatory scientists to develop and execute global regulatory strategy outside the US and Canada. The Sr. Director will be expected to take reasoned risks and leverage innovative regulatory strategies that can accelerate the development of assigned molecules. Key responsibilities include :- Provides leadership by developing and executing innovative regulatory strategies
- Works independently in a role that demonstrates organizational influence within and across functions. For example, influences cross-functional teams on clinical development strategy and trial design
- Acts as direct liaison with FDA and Health Canada
- Executes high quality communications with regulators and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues
- Actively seeks to deepen regulatory knowledge through constant learning
- Readily shares information and regulatory knowledge with others
- Engages in, influences, and shapes external environment initiatives related to portfolio assets
- Bachelor's degree in scientific area and at least 10 years of industry-related experience in regulatory affairs and/or drug development
- OR
- Advanced scientific degree (e.g., PhD, PharmD) with at least 8 years of industry-related experience in regulatory affairs and/or drug development
- Knowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory initiatives desirable
- Demonstrated deep knowledge of the drug development process
- Demonstrated ability to assess and manage risk in a highly regulated environment
- Demonstrated strong written, spoken and presentation communication skills
- Demonstrated ability to negotiate and influence
- Demonstrated attention to detail
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
- Ability to travel to US required (10-25%)
- Position location: Cork, Ireland
About Us
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!#J-18808-LjbffrApply safely
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