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 the Senior Manager, Global Labeling Devices. You will be r esponsible for the development, maintenance, and implementation of Instruction for Use (IFU) documents and Device Packaging Labeling content in line with US and EU standards and guidelines.

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:

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.

• 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).

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.

• 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.

• Authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance.

• Employs project management skills to coordinate global labeling sub-functions to contribute to the 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 GLL and/or GRL).

• Ensures labeling content conforms to regulatory requirements.

Management of Local Exceptions and LOC Interactions

• Manages the 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.

• Proactively strengthen and foster robust relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, device regulatory and commercial, to ensure highly effective communication of labeling strategy and content.

Precedent Search and Labeling Trends

• Conducts precedent searches, 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 (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 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.

• Participates 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.

Support in Managing Labeling Deliverables for Medium and/or High Complexity Products

• Assist in managing high complexity products by working with GLLs and labeling management on assigned labeling tasks such as review and edit labeling documents, assist in leading LWG meetings, coordinate labeling local update / exception process etc.

Minimum Requirements/Qualifications:

• BSc degree, preferred; BA accepted.

• Advanced scientific degree (MSc, PhD, or PharmD) preferred.

• 6+ years of pharmaceutical industry experience. This is inclusive of 4 years of labeling experience or combination of 4+ years regulatory and/or related experience.

• Knowledge of US and EU IFU product labeling regulatory requirements and guidelines.

• Familiarity with US and/or EU regulatory requirements and guidelines.

• Familiarity with other relevant regional regulatory nuances and requirements.

• Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development.

• Ability to co-author, revise and/or update product labeling (i.e. IFU, CCDS, USPI and EU SmPC) for regulatory submissions with appropriate supervision and guidance.

• Ability to identify factors and requirements necessary for regulatory recommendations

• Ability to develop regulatory strategies based on regulatory requirements and competitive landscape.

• Ability to use communication and interpersonal skills to build and maintain productive relationships across global teams.

• Ability to actively listen to stakeholders and understanding their perspectives.

• Negotiation skills: ability to resolve conflicts and reach agreements with team members, stakeholders and vendors.

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.

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