- Provide leadership and direction to staff regarding departmental policies, organizational goals, objectives, performance management, regulatory knowledge, and company policies.
- Hold individuals accountable for achieving goals and implementing the appropriate competency models.
- Remove barriers to ensure labeling activities are completed accurately, timely, and in compliance with regulatory and quality system requirements.
- Actively coach and mentor staff, including providing strategic guidance to staff on and labeling process questions.
- Ensure staff members receive appropriate training to perform their jobs.
- Empower individuals to make logical decisions, resolve issues, and execute tasks.
- Assure appropriate individual and team recognition.
- Support individual technical growth and development.
- Liaise with management colleagues to ensure coordinated and consistent approach to personnel management.
- Align labeling strategy with corporate directives and affiliate (US and Canada) priorities.
- Actively seek out information on the needs of internal and external customers and monitor US and Canadian regulations.
- Collaborate with business partners and management to evaluate and support priorities.
- Drive continued improvement and simplified work practices.
- Participate on management teams in implementation of mission, vision, strategic intent, budget, policies, procedures, and practices.
- Participate in business planning efforts.
- Successfully allocate staff and manage resources.
- Provide ongoing assessment of workloads to assure balanced and maximum efficiency of individual talent and capacity.
- Provide necessary resource support for key projects.
- Recruit, hire, and effectively train, onboard, and integrate new staff to meet current and future needs by understanding and anticipating required future skills.
- Build and maintain relationships with management in relevant areas.
- Participate in supporting cross-functional activities/projects.
- Remove barriers to ensure labeling activities are completed accurately, timely, and in compliance with regulatory and quality system requirements.
- Provide strategic guidance to staff on labeling process questions.
- Monitor regulations and the external environment as appropriate.
- Provide technical, administrative, and operational support for labeling-related systems and tools.
- Share regulatory knowledge with team on routine basis to establish trust and credibility.
- Actively involved in Label Assessment process, responsible product selection and ensure submission of final observations on time.
- Execute product transitions plan and ensure smooth transition and allocation of assets.
- Organise and facilitate staff meetings and forums.
- Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions.
- Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
- Regularly communicate within and across Global Labeling and GRA to facilitate sharing of information that allows the organization effectively support development and commercial teams.
- Participate in forums that share regulatory information across GRA and other Lilly teams and business partners.
- Constructively challenge teams to reach the best solutions to issues.
- Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions.
- Bachelor's degree in scientific field or health sciences discipline (for example, pharmacy, chemistry, or related scientific discipline).
- 5+ years pharmaceutical industry-related experience and /or regulatory affairs.
- Knowledge of US FDA/Health Canada and practices and awareness of evolving regulatory reform initiatives.
- Knowledge of drug development process and global health authority guidelines.
- Demonstrated ability to work in a global matrix environment.
- Demonstrated ability to communicate effectively (verbally and written), and to motivate and inspire others.
- Demonstrated flexibility and strong negotiation skills.
- Experience in interpreting and applying regulations.
- Supervisory experience.
- Ability to manage multiple projects/people simultaneously.
- Project management experience.
- Ability to influence and lead.
- Effective interpersonal skills.
- Willingness to work outside of normal business hours to accommodate US/EU/Asian time zones.
Senior Manager - Cork, Ireland - Lilly
Description
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
Senior Manager - GRA Global Labeling
Purpose:
The Senior Manager - GRA Global Labeling provides direction, leadership, and technical/process expertise to their team supporting labeling development and maintenance for Lilly products. This position provides strategic input, focuses on results, thinks critically, and emphasizes and drives cross-functional team collaboration to the achievement of goals and objectives.
The Senior Manager/Senior Group Manager is responsible for appropriate resourcing, staff development and performance management, and accountable for completion of regulatory labeling activities/projects and identification/implementation of process improvements.
Primary Responsibilities:
Personnel Management and Leadership
Strategic Planning and Implementation
Staffing
Facilitate Labeling Process
Lead/Influence/Partner
Minimum Qualification Requirements :
Other Information/Additional Preferences:
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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