at Takeda Pharmaceuticals in Springfield, Illinois, United States
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Sr Manager, GRA Labeling Quality where you will Partners with internal stakeholders and external CRO partners such as Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE (safety), Regulatory Therapeutic Areas, Local Operating Companies and Supply Chain on all matters related to labeling compliance. As part of the GRA Labeling Quality team member you will report to the Sr Director, Global Labeling GRAD
How you will contribute:
+ Ensures clear and timely communication about labeling compliance activities with stakeholders.
+ Manages activities related to compliance of labeling events and end-to-end tracking of labeling events
+ Escalate issues/problems to management as needed
+ Maintains strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory Affairs and labeling
+ Supports evaluation and investigate of Quality Events, including conducting root cause analyses and develops corrective and prevention action plans
+ Identifies and proposes process improvement opportunities and solutions
+ Supports other labeling compliance activities as required
+ Responsible for demonstrating Takeda leadership behaviors
+ Drives compliance to labeling processes, labeling content, and adherence to KPIs and timeliness indicators.
+ May present or support audits and inspections related to global and regional labeling processes and compliance
+ Supports investigations into labeling quality events and ensure that corrective and preventative actions are appropriately identified and completed
+ Escalates issues/problems to Labeling Compliance management as needed
+ Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
+ Knowledge of business area and regulatory environment and ability to identify and proactively manage the interactions necessary for achieving business goals and objectives
+ Awareness of global health authorities, regulations, product approval, labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices
+ Excellent analytical, technical, and problemsolving skills (TQM or Six Sigma experience preferred)
+ Project management abilities
+ Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
+ Comfortable working across functions, regions and cultures
+ Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
+ Ability to distill complex issues and ideas down to simple comprehensible terms
+ Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
+ Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
+ Ability to strategize, communicate and resolve issues independently
+ Self-motivated, self-starter with the ability to work independently and in a team with a flexible mindset
+ Independently manage product workload and coordinates with stakeholders to ensure timely completion of product work deliverables
+ Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
+ Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
+ Effectively manage complex topics and a matrixed environment, building strong relationships with stakeholders enterprise-wide
+ Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
+ Comfortable challenging the status quo and bringing forward innovative solutions
+ Ability to take risks implementing innovative solutions, accelerating timelines throughout processes
+ Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
+ Ability to work in a global ecosystem (internal and external) with a high degree of complexity
+ Bachelor’s degree (or equivalent) required. Masters preferred.
+ 5+ years experience in Pharmaceutical or Medical Device industry, with 3 years in Regulatory Affairs, labeling or quality assurance/compliance.
+ Systems Knowledge -knowledge of Quality Management Systems, including EDMS, and Deviation (Trackwise) systems
+ Regulatory Familiarity -awareness of European, US and international regulations relative to labeling
+ Industry Knowledge -understanding of the medical device or pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes.
+ Analytical Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
+ Communication – ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
+ Teamwork – Ability to work with team members in a friendly, professional manner. Motivate and empower others. Manage teams to work productively in a high-pressure environment
+ Knowledge Sharing – ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables, and models for others to use.
+ Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
+ Project Management abilities
+ Must be strong communicator, and ability to explain complex regulatory issues, trends, and strategies to a wide range of stakeholders
+ Experience managing relationships with CROs and/or contractors a plus.
What Takeda can provide
+ Comprehensive Healthcare: Medical, Dental, and Vision
+ Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
+ Health & Wellness programs including onsite flu shots and health screenings
+ Generous time off for vacation and the option to purchase additional vacation days
+ Community Outreach Programs and company match of charitable contributions
+ Family Planning Support
+ Flexible Work Paths
+ Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to peo