Associate Director
3 days ago
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 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.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 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. In-house 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
Purpose:
The purpose of the Associate Director/Director, Global Regulatory Affairs (GRA) Global Core Labeling (P4/P4-2) role is to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components. The Associate Director/Director ensures timely delivery of global labeling to Lilly affiliates to facilitate simultaneous global submissions. Additionally, the Associate Director/Director leads timely updates and communication of core labeling changes throughout the product lifecycle.
Primary Responsibilities:
Global Labeling Leadership
- Provide leadership for development of global labeling strategy to facilitate global simultaneous submissions.
- Implement “Accelerate Reach and Scale” initiatives related to global labeling strategy.
- Serve as global labeling representative for assigned products to drug development teams and affiliate regulatory business partners.
Core Labeling Development and Maintenance
- Lead the development and maintenance of core labeling (i.e., Core Data Sheet (CDS), Core Device Labeling (CDL), Core Carton, Core Quick Reference Information, and Core Instructions for Use, and CMC Core Labeling Content).
- Lead the preparation activities and facilitate approval of core labeling by the Global Product Labeling Committee (GPLC) and Global Labeling Council (GLC).
- Communicate initial and revised core labeling to global affiliates and provide support and consultation, as necessary.
- Lead the development and maintenance of clinical trial Instructions for Use.
Labeling Process Excellence
- Optimize core labeling exception process. Manage core labeling exception requests and facilitate approval from leadership.
- Support periodic labeling assessments to assess compliance of affiliate product information with core labeling.
- Serve as subject matter expert for core labeling. Effectively resolve identified gaps and issues and help drive continuous improvement in labeling processes.
- Anticipate and resolve key technical or operational issues that can impact labeling development and timelines.
- Develop and present metrics to governance and other forums to monitor and improve the labeling exception process.
Lead/Influence/Partner
- Exemplify the Team Lilly behaviors of Include, Innovate, Accelerate, and Deliver.
- Model the innovation, leadership behaviors, and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
- Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners.
- Partner with Global Regulatory Lead and Device Strategy Lead to support global labeling strategy.
- Ensure timely communication of global labeling to global affiliates.
- Partner with Labeling Implementation Associates to ensure local labeling aligns with core labeling.
Minimum Qualification Requirements:
- Bachelor’s degree in a scientific or health sciences discipline (or equivalent experience).
- Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years.
- Demonstrated knowledge of the drug development process and Lilly regulatory/business strategies.
- Demonstrated ability to assess and manage risk in a highly regulatory environment.
- Demonstrated ability to lead, influence and partner cross-functionally.
- Demonstrated strong communication skills: writing, presenting, listening.
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.
- Demonstrated attention to detail and organizational skills.
- Ability to learn and use new software/technology.
- Ability to manage multiple tasks simultaneously.
Other Information/Additional Preferences:
- Knowledge of procedures and practices related to drug and device labeling and awareness of evolving global regulatory reform initiatives.
- Ability to apply therapeutic expertise.
- Project management experience.
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.
#WeAreLilly
#J-18808-Ljbffr
-
Director/Associate Director, Regulatory CMC
1 week ago
Cork, Ireland BioMarin International Limited Full timeBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...
-
Associate Director Global Regulatory Affairs
1 week ago
Cork, Ireland Life Science Recruitment Ltd Full timeAssociate Director Global Regulatory Affairs Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working. Responsibilities: People Management: Recruit, develop, and retain a...
-
Associate Director
7 days ago
Cork, Ireland Eli Lilly and Company Full timeAt 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...
-
Associate Director Clinical Regulatory Scientist
21 hours ago
Cork, Ireland Life Science Recruitment Full timeAssociate Director Clinical Regulatory Scientist (Paediatrics) Associate Director Clinical Regulatory Scientist (Paediatrics) Our client, a global pharma company, is currently recruiting for an Associate Director Clinical Regulatory Scientist (Paediatrics) to join their team on a permanent basis. As Associate Director Clinical Regulatory Scientist, you will...
-
▷ Apply in 3 Minutes: Associate Director
7 days ago
Cork, Ireland Ayesa Company Full timeAyesa Cork, Ireland Associate Director Hybrid Company Description Ayesa is a globally-oriented, forward-thinking company deeply committed to fostering diversity, inclusion, equity, and sustainability. These principles form the bedrock of our dedication to our 11,300 employees and serve as the driving forces behind our spirit of innovation. With a presence...
-
Associate Director
1 week ago
Cork, Ireland Cpl Resources Full timeAssociate Director Our clients advisory Financial Accounting division are a group of proactive accounting specialists who are focused on providing practical solutions to their clients complex financial reporting issues. The advisory team must be able to respond quickly to fast moving business processes and timelines whether assisting with advice related to...
-
Cork, Ireland Life Science Recruitment Ltd Full timeAssociate Director Clinical Regulatory Scientist(Paediatrics) Our client, a global pharma company are currently recruiting for an Associate Director Clinical Regulatory Scientist (Paediatrics) to join their team and a permanent basis. As Associate Director Clinical Regulatory Scientist you will develop and execute the regulatory strategy for the US and...
-
Associate Director
7 days ago
Cork, Ireland AtkinsRéalis Full timeAtkinsRéalis is one of the world’s leading providers of engineering professional consulting and support services with offices across Ireland. AtkinsRéalis Ireland is seeking a dynamic and experienced Associate Director to join our thriving Bridge Design Team in Cork. With a substantial portfolio of secured projects and a robust pipeline of exciting...
-
Associate Director Clinical Development
7 days ago
Cork, Ireland Life Science Recruitment Full timeAssociate Director Clinical Development Our client, a global pharma company, is continuing to add talented clinical professionals to their Clinical Development team, and is currently recruiting for an Associate Director to join their team on a permanent basis. You will have experience working in Clinical Trials/Clinical Research/Clinical Operations/Clinical...
-
Cork, Ireland BIOMARIN Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
-
Associate Director – Clinical Drug Supply
1 week ago
Cork, Ireland Total Supply Corp Full timeAssociate Director – Clinical Drug Supply 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...
-
Associate Director
1 week ago
Cork, Ireland Eli Lilly and Company Full timeAt 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...
-
Cork, Ireland Eli Lilly and Company Full timeAt 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...
-
Cork, Ireland Eli Lilly and Company Full timeAt 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...
-
Associate Director
6 days ago
Cork, Ireland Eli Lilly and Company Full timeAt 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...
-
Cork, Ireland Nbsalonspa Full timeAssociate Director, Clinical Trial Program Lead 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...
-
Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...
-
▷ 3 Days Left! Associate Director
5 days ago
Cork, Ireland Eli Lilly and Company Full timeAt 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...
-
Cork, Ireland Eli Lilly and Company Full timeAt 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...
-
Cork, Ireland Eli Lilly and Company Full timeAt 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...
