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Job Description
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.
How you will contribute:
- The Director, Global Labeling Quality, provides direction and leadership for activities related to labeling quality globally, except EU and extended EU.
- Partners with internal stakeholders, including the Director of Global Labeling Quality EU, external CRO... partners, and Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE (safety), Regulatory Therapeutic Areas, Local Operating Companies Global Quality, and Supply Chain, on matters related to global labeling quality.
- Responsible for successful labeling event management and tracking of global labeling updates worldwide, except EU and Extended EU.
- Guide activities to provide a state of readiness for Health Authority inspections within Global Labeling and supporting local country (LOC) activities, including the development of strategic internal audit plans, and the execution of internal audits.
- Evaluates and review compliance with Global Labeling procedures.
- Evaluate proposed commitments to Health Authorities in response to inspection findings for Global Labeling and LOC Labeling commitments.
- Guide activities to provide a state of readiness for Health Authority inspections within Global Labeling and supporting local country (LOC) activities, including the development of strategic internal audit plans, and the execution of internal audits.
- Evaluates and review compliance with Global Labeling procedures.
- Evaluate proposed commitments to Health Authorities in response to inspection findings for Global Labeling and LOC Labeling commitments.
- Provides regulatory and technical expertise to manage the regulatory inspection preparation and execution processes, including the development of related tools and best practices.
- Responsible for alignment with global strategic initiatives related to labeling events and the processes and systems used to manage labeling events.
- Works with cross-functional and regional teams to advance the Global Labeling process execution.
- Communicate and escalate critical matters to leadership.
- Supports post-marketing surveillance inspection and audit readiness and inspection and audit management activities.
- Supports coordination of document requests and audit/ inspection interviews.
- Identifies and proposes process improvement opportunities and solutions.
- Supports other labeling operations activities as required.
- Responsible for demonstrating Takeda leadership behaviors.
- Drives compliance to labeling event quality, labeling content, and adherence to KPIs and timeliness indicators.
- Presents global and regional labeling processes and quality to inspectors and auditors.
- Leads investigations into labeling quality events and ensures that corrective and preventative actions are appropriately identified and completed.
- Escalates issues/problems to Labeling Quality management as needed.
Minimum Requirements/Qualifications:
- Bachelor's degree (or equivalent) required. Masters preferred.
- 7+ years experience in the Pharmaceutical or Medical Device industry, with 4 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 - the ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
- Communication - the 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 - the ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through the use of information; improve information capital by contributing experience, deliverables, and models for others to use.
- Interpersonal Flexibility - the ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
- Project Management abilities.
- Must be a 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 is a plus.
What Takeda can offer you:
- 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 a 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 people around the world.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $156,800 to $224,000 based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - MA - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
#LI-Remote
Juncos Puerto Rico

Salary Criteria