Associate Director - RDMC Cork, Global Medical Review and Safety Management
Job Details
Full Job Description
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.
Organisation Overview:
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!
The purpose of the role of Associate Director - R esearch D evelopment M edical Capabilities (RDMC) Cork, Global Medical Review and Safety Management is to provide strategic and personnel leadership to the Global Patient Safety (GPS) organization in Cork including Safety Management and Global Medical Review within the GPS Safety Management, Reporting, and Data Science (SMRD) organization. The Associate Director/Director will work in close collaboration with global leaders responsible for relevant functions , including S afety M anagement R esearch D evelopment (SMRD) leadership at all Regional Centres worldwide, and is accountable for the team’s alignment to and integration with the global business needs and strategy through the direct management and development of Global Medical Review and SMRD personnel .
The Associate Director will provide tactical direction to ensure the GPS team at Cork demonstrates strong technical capabilities and continues to evolve and grow to meet the organizational needs and external environment .
Primary Responsibilities:
Global Leadership
Functional Leadership
Supervise Medical Review (MR) physicians and scientists and Safety Associates (SA) within SMRD at RDMC Cork
Recruit, develop, and retain a strategic and talented workforce with strong pharmacovigilance skills and clinical knowledge to deliver high performance in their area of work and potential to learn and evolve.
Ensure the team is agile and adaptable to meet the needs of changing portfolio and external environment.
Drive an inclusive and cohesive organizational culture aligned to Lilly values and expectations.
Coach and mentor direct reports (supervisors and talented employees) to build strong leadership and technical capabilities for the future organizational needs.
Collaborate regularly with the other SMRD Regional Centres to support global consistency in the handling of adverse event cases.
Lead local actions to manage or clarify a safety issue in collaboration with the responsible global teams.
S erve as a functional interface for Medical Review and Safety Management issues.
Actively participate in the GPS SMRD global team, contributing to the improvement of processes, strategic changes, and the management of projects
Enterprise Leadership
Responsible for cross-functional collaboration to ensure alignment of goals and deliverables, readjusting as business needs dictate.
Partner closely with global GPS partners for efficient resource forecasting, planning, and utilization to meet business objectives .
Build collaborative working relationships with staff throughout SMRD and across GPS as well as with Development and Brand Teams and Affiliate staff globally to ensure full cooperation and high-quality medical evaluation of safety data for global regulatory purposes.
Act as a Lilly GPS representative for both internal and external customers, interacting as described in corporate guidelines and policies.
Build strong relationships with key customers, representing and championing the role of safety in the organization.
Have a strong foundational knowledge of pharmaceutical industry, including understanding of relevant aspects of the regulatory, industry, and scientific environments, laws, regulations, and guidance.
Assurance of local and global drug safety quality and regulatory compliance
Implement and follow internal procedures to ensure compliance and quality of the safety operations processes.
Take leading local role during audits and inspections to ensure accurate information is provided as needed.
Maintain awareness of the changing global regulatory environment and participate in adaptation of the organization’s policies and practices.
Maintain audit and inspection readiness through proactive preparedness activities.
Understand the roles and responsibilities of the EU qualified Person for Pharmacovigilance (QPPV) and ensure support is provided to enable the QPPV to fulfil the QP’s legal responsibilities.
Other Job Expectations
Maintain scientific expertise in areas of interest or specialty.
Understand and comply with all compliance policies, laws, regulations, and the Red Book.
Adapt to the changing global regulatory environment.
Understand the confidential nature of company information and take necessary steps to ensure its protection.
Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.
Minimum Qualification Requirements:
Advanced medical related graduate degree, such as: DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years of experience in related scientific field ,
OR
- BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or developmen t.
AND
P revious clinical experience .
Other Information/Additional Preferences:
Demonstrated leadership, interpersonal and management skills , 2+ years of direct management experience preferred.
Ability to influence others (both cross-functionally and within the functio n) to create a positive working environment.
Ability to work in a multicultural virtual global environment and partner across matrix organization to collaborate with peers locally and globally.
Fluent English language written, spoken, and presentation communication skills.
Essential computer skills (e.g., office suite and internet browsers).
Availability to travel when .
Previous experience authoring/interpreting SOPs establishing quality systems and delivering training.
Project management skills.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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