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Job Description

About the role:

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma derived therapies for patients with immunologic, hematologic, and other complex diseases.  

The Global Regulatory Device Labeling Strategy Lead (Senior Manager) Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling and is:

• Responsible, for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Device Development, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of Instruction for Use (IFU) documents and Device Packaging Labeling content in line with US and EU standards and guidelines.  

• Responsible for developing regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.

• Providing advice on current labeling requirements, templates, tools, and Health Authority-issued guidance pertaining to pharmaceutical drug and device.

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

How you will contribute:

• 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.

• Assists in the development of labeling strategies and content and to ensuring cross- functional alignment for other medium and/or high complexity products (including combination, Software as a Medical Device, and standalone medical device products).

• Manages labeling and device labeling strategies for the PDT BU via the development and lifecycle management of the IFU, CCDS, US, and EU labels.

• 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.

• Assists in the development of innovative regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion. 

• Prepares strategic labeling vision for early development programs and gains alignment from internal stakeholders.

• Draws on labeling precedent, Health Authority feedback, and guidance, to create innovative labeling strategies.

• Provides guidance on combination product/drug-device labeling.  

• With support of related functions interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. 

• Develops creative solutions for data presentation and gains consensus by labeling teams to meet the requirements of the Health Authorities 

• Manages global labeling team and cross-functional projects.  

• Manages IFU, CCDS, US, and EU Labeling Teams in the development and maintenance of labeling. 

• Actively engages cross-functional labeling stakeholders to gain consensus on labeling strategy. 

• Identifies and resolves conflicts/issues to reach labeling decisions including escalation to management for dispute resolution.

• Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to labeling and communicates the impact on the PDT BU products.

• Provides guidance to Regulatory affiliates as necessary in assessment of labeling changes to ensure timely implementation.  

DIMENSIONS AND ASPECTS 

Technical/Functional (Line) Expertise

• In close collaboration with the Takeda R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance.

• Project manages new or updated labeling to ensure compliance with internal procedural or Health Authority submission timelines.

Job Description / Role Profile

• Manages and facilitates review of IFUs and CCDSs and regional labeling, as appropriate, via the Labeling Team and executive governance committees for PDT BU products, in collaboration with the Head of Global RA Marketed Products and Labeling.

• Prepares final proposed labeling for review by the Labeling Team and approval by the executive governance committees, as appropriate, prior to internal approval and/or submission to health authorities, in collaboration with the Head of Global Labeling. 

• Manages the preparation of submission-ready labeling components, consults with affiliates on Health Authority communications regarding labeling.

• Ensures internal and external stakeholder awareness of proposed and newly approved labeling changes, as required.

• Ensures compliant version control of product labeling and other related documentation within the Takeda document management systems.

• Ensures QC of IFUs, CCDSs and other labeling documents.

• Updates labeling decision records to ensure labeling history is appropriately tracked and archived.

• Ensures Takeda employee awareness of, and adherence to, Takeda Labeling processes via regulatory training.

• Documents labeling tracking information as required in end to end tracking systems to facilitate overall compliance and oversight of labeling activities

Leadership  

• Ability to motivate, mentor and manage diverse cross functional teams

• Global perspective with a demonstrated ability to work across functions, regions, and cultures

• Ability to identify potential challenges and opportunities and make recommendations 

• Effective collaborator who can engender credibility and confidence within and outside the company

• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization

• Invests in helping others learn and succeed 

• Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed.

• Builds and enhances strategic, cross-functional, stakeholder relationships through thoughtful engagement and leadership (including, the planning, assigning, and direction of work).

Decision-making and Autonomy

• Able to act decisively and exercise sound judgment in making decisions with limited information

• Able to make clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence

• High ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities

• High ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution

• Develops executable plans and meets budget and deadlines

Interaction

• Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU

• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions

• Strong communicator, able to persuasively convey ideas verbally and in writing.

Innovation

• Disruptive thinker with the ability to influence and change how R&D used data to make decisions and set priorities

• Continuously challenging the status quo and bringing forward innovative solutions

• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Complexity

• Delivers solutions to abstract problems across functional areas of the business.  

• Identifies and solves fundamental issues for major functional areas through assessment of intangible variables. 

• Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through influencing skills.

• Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity

• Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy

• Resilient and comfortable working through large scale global change management 

• Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU and international markets.

Minimum Requirements/Qualifications:

• Minimum of 4-7 years of experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.).  Up to 3 years of direct experience in a global, US, or EU labeling role is desired. Experience in plasma-derived therapies and biologics preferred.

• Bachelor’s or Master’s degree required. Advanced scientific or health sciences degree or equivalent relevant experience preferred.

• Must have a detailed understanding of pharmaceutical drug and device development and global regulations pertaining to labeling, specifically, EU and US labeling requirements and guidance.  Combination product/drug-device labeling knowledge is preferred.  Advertising and promotion knowledge is a plus.

• Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.

• Understanding of SPL format, requirements and guidance for legacy and PLR labels.

• Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labeling Tracking Systems to support labeling documentation, tracking, and compliance activities.

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 "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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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:

Boston, MA

U.S. Base Salary Range:

$133,000.00 - $209,000.00

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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