Associate Director, Global Labeling Devices

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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.

As Associate Director, Global Labeling Devices, you will be responsible for the development, maintenance, and implementation of Instruction for Use (IFU) documents and Device Container Labeling content in line with US and EU standards and guidelines.

Provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements.

Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team (GDT) to ensure that regulatory device labeling requirements are met for assigned products.

How you will contribute :

With guidance from leadership

Management of Labeling Cross-Functional Teams

• Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content for the Information For Use (IFU) and key global labeling documents.
• Collaborates cross-functionally to provide input into Clinical IFU, design input requirements, quality system required documentation, human factors strategy, and regulatory strategy.
  
  

Interface with Senior Management Cross-Functional Team (GLOC)

• In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain IFU labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels.
• Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.
  
  

Labeling Documents Authoring, Submission, and Labeling Negotiations

• Authors new/revised IFU content for the TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance.
• Provides input into the with adequate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into the IFU CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs.
• Independently authors/manages of outgoing communications regarding significant labeling changes and for assigned products with appropriate supervision and guidance.
• Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL).
• Interpret laws, regulations, and guidance documents relevant to the development and implementation of IFU labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements.
  
  

Management of Local Exceptions and LOC Interactions

• Manages process for alignment of local labeling with IFU for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance.
• Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc.
  
  

Escalation Process and Stakeholder Management

• Appropriately escalates issues to Global Labeling management and the Global Regulatory
  
  

Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation.

• Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content.
  
  

Precedent Search and Labeling Trends

• Conducts precedent, analyzes relevant competitor IFU labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible
  
  

Working within Labeling Team and GRA

• Represents Global Labeling Devices at Global Regulatory Team (GRT)
• Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.
• Represents global labeling in departmental and cross-functional task-forces and initiatives.
• Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.
  
  

Continuous Improvement

• Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.
  
  

Minimum Requirements/Qualifications :

• BSc degree, preferred; BA accepted.
• Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
  
  

Strategic Thinking

• Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management.
• Demonstrates an understanding of core business aspect.
  
  

Communication

• Ability to effectively collaborate with global cross-functional teams.
• Ability to use communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation formats.
• Ability to promote regulatory decisions across global cross-functional teams.
• Ability to actively listen to stakeholders, understanding their perspectives and addressing their concerns.
  
  

Analytical and Problem Solving Skills

• Demonstrates strong analytical and problem-solving skills with ability to analyze risk and
  
  

think strategically.

• Ability to comprehend and explain complex technical regulatory issues.
• Ability to assess labeling related regulatory requirements, identify issues or opportunities, escalate to leadership, as needed, and make informed decisions.
• Ability to proactively identify risks, develop risk mitigation strategies, and appropriately escalate to leadership.
  
  

Technical

• Strong knowledge of US and EU IFU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).
• Knowledge of US and/or EU regulatory requirements and guidelines.
• Knowledge of other relevant regional regulatory nuances and requirements.
• Knowledge of scientific principles and regulatory/quality systems relevant to drug development.
• Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance.
• Ability to contribute towards target labeling profile (TLP) with minimal supervision and guidance.
• Understanding of the broad concepts within global labeling and implications across the organization and globally.
• Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections.
  
  

Business/Organizational Awareness

• Strong knowledge of labeling role in project teams, and importance of cross-functional collaboration.
• Knowledge of R&D organizational structure, including its functions and interdependencies.
• Demonstrates project management skills and ability to independently deliver accurate and complete work while adhering to designated timelines for the execution of submission plans, regulatory requirements and business objectives.
• Demonstrates a strategic mindset and ability to align product labeling strategies with broader business objectives.
• Ability to independently prioritize assigned global labeling activities and tasks.
  
  

Leadership

• Acts proactively and effectively as member of multi-disciplinary teams.
• Ability to effectively lead multi-disciplinary, cross-functional teams with appropriate supervision and guidance.
• Ability to provide alternatives and to adopt breakthrough ideas, innovations and initiatives.
• Acts as an ally to support individuals as a whole and intentionally promotes an inclusive culture and fosters a climate that encourages open dialogue, feedback and diverse opinions.
  
  

Core competencies

• Demonstrates Takeda values Integrity, fairness, honesty, and perseverance.
• Ethical decision making considers the impact of decisions and actions on others, adhering to professional codes of conduct and making choices that align with Takeda values.
• Timeline management ability to effectively manage time, prioritize tasks, and meet deadlines.
• Proactiveness, adaptability and flexibility ability to adapt to changing circumstances, learn new skills and work with diverse global team by being open to feedback.
• Attention to details demonstrates attention to details ensuring accuracy of the labeling deliverables of the assigned product(s).
• Negotiation skills Demonstrates strong negotiation skills in collaborating with cross functional teams, stakeholders, and vendors, aligning diverse perspectives, and driving consensus to achieve project objectives.
  
  

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" following Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary:

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range :

$153,600.00 - $241,340.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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

Job Exempt:

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.