Job Information
Takeda Pharmaceuticals Director, Global Labeling Devices in Topeka, Kansas
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Job Description
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 Associate Director/Director, Global Labeling Devices
How you will contribute:
Provide strategic oversight and leadership for Takeda Global Labeling (GL) devices, including labeling vendors assigned to GL responsibilities and tasks.
Develop, implement, and oversee appropriate processes and systems to ensure compliance with external regulatory labeling requirements and internal Takeda standards.
Lead both internally and externally, contributing to cross-functional initiatives and influences the field as applicable.
Provide leadership and development for direct reports, including those that serve as global labeling leads responsible for the design and execution of global labeling strategies in collaboration with their regional counterparts.
Plan and manage core device labeling (including creation, maintenance, distribution, tracking and implementation), US, and EU device labeling processes in line with strategic priorities and compliance with government regulations/Takeda quality standards to ensure commercial product integrity
Establishes and manages relationships with labeling vendors to ensure the effective implementation of labeling processes to meet business needs and regulatory requirements.
Monitor Local Operating Company (LOC) compliance with labeling activities, takes corrective actions as needed
Manage preparation of the Pharmacovigilance Site Master File (PSMF) labeling sections, and inspection/audit activities
Participate with influence in or leads departmental and cross-functional task-forces and initiatives
Identify risks with mitigation plans and communicates with GL Head
Serve as a device labeling resource to the Therapeutic Area Units (TAUs), Marketed Product Development (MPD), and US/EU Labeling Operations as well as LOCs for device labeling issues
Lead the development of new strategic and operational initiatives to drive impactful and efficient updates to the Global Labeling device processes, including Core, US and EU device labeling
Monitor industry labeling and medical device trends and regulations/requirements and proposes actions as appropriate
Ensure consistency and alignment across combination product programs across TAUs and MPD
Contribute to continuously improve required trainings and resource materials, as well as quality topics for device labeling.
Provide leadership to GL staff (including Takeda employees, vendors, and partners) in establishing roles/responsibilities and accountabilities across the labeling function(s).
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BSc Degree, preferred. BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred
Associate Director: 8+ years of pharmaceutical industry experience (inclusive of 6 years of labeling experience or combination of 8+ years regulatory and/or related experience). Experience in both pharmaceutical combination products (drug + device) and medical device regulations, requirements and standards preferred.
Director: 10+ years of pharmaceutical industry experience (inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience). Experience in both pharmaceutical combination products (drug + device) and medical device regulations, requirements and standards preferred.
Understanding of scientific principles and regulatory/quality systems relevant to drug and device development.
Knowledge of global standards and regulations related to CCDS, IFU and Product Labeling (US and EU experience required, other regional labeling experience also preferred).
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
Demonstrates problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions.
Must work well with others and within global teams.
Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identifies issues; offers creative solutions and strategies, including risk mitigation strategies.
Responsible for demonstrating Takeda leadership behaviors.
TRAVEL REQUIREMENTS:
Willingness to travel to various meetings, including overnight trips.
Requires approximately up to 10-30% travel.
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 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– $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.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
Empowering our people to shine:
Takeda is proud of 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.
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.
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
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
#LI-Remote