Director, Global Labeling Operations

Company: Takeda Pharmaceutical
Location: Clifton
Posted on: January 19, 2023

Job Description:

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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.

Join Takeda as a Director, Global Labeling Operations where you will develop, implement, and oversee Takeda's US and EU Labeling Operation Teams.

You will contribute internally and externally, to cross-functional initiatives and influencing the field as applicable as part of the Global Regulatory Affairs team. You will report to Head of Global Labeling Operations and Excellence.

How you will contribute:

As Director, Labeling Operations you will establish and lead the Global Labeling Operations function. This includes:

• Responsible for the Labeling Operations strategy to deliver high quality submission labeling and artwork that meets regulatory timelines and that is in compliance with US and EU (CP, MRP, and DCP) artwork guidance and implementation timelines.
• Establish and lead the internal and external Labeling Operations US and EU Teams.
• Responsible for the Labeling Operations strategy to deliver high quality labeling artwork that meets regulatory timelines and that is in compliance with US and EU (CP, MRP, and DCP) artwork guidance and implementation timelines.
• Provide US and EU regulatory expertise and guidance to Global Labeling, Global Supply Chain, Legal, Global Regulatory Strategy, Commercial, and other internal stakeholders.
• Provide expert advice on current US and EU labeling requirements, templates, tools, and Health Authority-issued guidance.
• Provide guidance and oversight for EU labeling translations. Oversee vendor performing artwork and translations activities on behalf of Takeda:
  • planning, assigning, and directing work via vendor interface
  • providing performance feedback to vendor(s)
  • escalating non-performance or compliance issues via the appropriate procedures and systems
  • working with vendor management to ensure appropriate trained staff to support Takeda programs
    • Formulate regulatory labeling strategies for implementation of US/EU new and revised prescribing/patient information and packaging and timing relating to labeling revisions. Skills you will have:
      • Embrace and demonstrate a diversity and inclusion mindset and role models these behaviors for the organization
      • Technical/Functional (Line) expertise (breadth and depth of knowledge, application, and complexity of technical knowledge)
      • Strong knowledge of business area, regulatory environment, and ability to identify and proactively manage the interactions necessary for achieving business goals and objectives
      • Demonstrated knowledge of global health authorities, regulations, product approval, labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices
      • Project management abilities
      • Leadership (vision, strategy and business alignment, people management, communication, influencing others, managing change)
      • Demonstrated ability to work across functions, regions, and cultures
      • Enterprise level leadership with the ability to inspire, motivate and drive results
      • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
      • Ability to distil complex issues and ideas down to simple comprehensible terms
      • Broad decision-making responsibilities:
        • ability to make highly complex decisions that impact the enterprise
        • accountable for decision making for designated function
        • ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
        • ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution
        • 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
        • Breadth of knowledge required across end-to-end labeling process, functions, and stakeholders Minimum Requirements/Qualifications:
          • Bachelor's degree (or equivalent) required. Masters preferred.
          • 10+ years experience in Pharmaceutical or Medical Device industry, with 8 years in Regulatory Affairs, labeling or quality assurance/compliance.
          • Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling artwork
          • Excellent knowledge of EU and US labeling requirements and ability to communicate and strong operational regulatory and business experience, including knowledge of regulations and guidance governing drugs and biologics labeling in all phases of development for US and/or EU (relevant to role)
          • Preferred expertise in packaging regulations and processes involved in the generation and review of labeling artwork/mockup
          • Knowledge of the requirements for artwork in US and/or EU (relevant to role). Experience in the preparation and submission of artwork using artwork management systems (e.g. BLUE, Webcenter) beneficial
          • Ability to proactively identify regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
          • Expertise in labeling artwork, supply chain, Regulatory Strategy, and commercial
          • Knowledge of global guidance relevant to labeling, drug development, and commercialization of prescription medicines 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 candidate 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
              
              Massachusetts - Virtual
              
              Worker Type
              
              Employee
              Worker Sub-Type
              
              Regular
              Time Type
              
              Full time
              
              

Keywords: Takeda Pharmaceutical, Clifton , Director, Global Labeling Operations, Executive , Clifton, New Jersey