Senior Manager, Regulatory Affairs for Marketed Products (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 an Associate Director, Global Regulatory Affairs Marketed Products you will: Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Are a leader within the department and within R&D contributing to department and cross functional Takeda initiatives and influencing the field as applicable. Provide leadership/contributes as global regulatory lead (GRL) responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. How you will contribute: The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed in line with changing regulatory and business needs. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement, and communicating in a professional and timely manner. Proactively anticipates risks and develops solutions/scenario planning for identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of project(s). The Associate Director will lead all submission types. Serves as the primary FDA contact. Leads and manages FDA meetings. Responsible for demonstrating Takeda leadership behaviors. Manages junior staff as needed. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in departmental and cross-functional task-forces and initiatives. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Supports the lead regulatory reviewer in due diligence for licensing opportunities. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates solid, increasingly independent regulatory strategy skills, including an understanding of core regulatory concepts and their organizational and global implications. Proactively identifies regulatory issues and proposes creative, practical solutions and strategies, including risk mitigation. 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. 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: $154,400.00 - $242,550.00 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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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.

Director of Worldwide Regulatory Compliance for Product Portfolio (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 an Associate Director, Global Regulatory Affairs Marketed Products you will: Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Are a leader within the department and within R&D contributing to department and cross functional Takeda initiatives and influencing the field as applicable. Provide leadership/contributes as global regulatory lead (GRL) responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. How you will contribute: The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed in line with changing regulatory and business needs. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement, and communicating in a professional and timely manner. Proactively anticipates risks and develops solutions/scenario planning for identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of project(s). The Associate Director will lead all submission types. Serves as the primary FDA contact. Leads and manages FDA meetings. Responsible for demonstrating Takeda leadership behaviors. Manages junior staff as needed. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in departmental and cross-functional task-forces and initiatives. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Supports the lead regulatory reviewer in due diligence for licensing opportunities. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates solid, increasingly independent regulatory strategy skills, including an understanding of core regulatory concepts and their organizational and global implications. Proactively identifies regulatory issues and proposes creative, practical solutions and strategies, including risk mitigation. 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. 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: $154,400.00 - $242,550.00 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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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.

Senior Manager Inflammatory Disease Research - Immunology (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Objective / Purpose: The GI-Drug Discovery Unit at Takeda is a team of experienced, innovative and collaborative drug discovery scientists building an industry-leading portfolio of drugs for inflammatory and GI diseases with high unmet medical need. We are seeking a leader with significant experience in building and leading biology and cross-functional drug discovery teams to establish a new group focused on chronic autoimmune diseases. The Director Inflammatory Drug Discovery Will be responsible for developing industry-leading therapeutics for patients with inflammatory diseases by leading a research group focused on drug development from target identification through to candidate selection. Will recruit, retain, and develop a large team of world class, highly innovative in vitro and in vivo research biologists focused on understanding the molecular, cellular and organ-level drivers of inflammatory disease processes, and identifying and developing drug candidates. Will be scientific research thought leader within the Drug Discovery Unit (DDU), working within a highly matrixed environment to build an industry-leading preclinical and early clinical therapeutic pipeline for Inflammatory Diseases. Will set the discovery portfolio goals for high priority autoimmune diseases and ensure alignment with key stakeholders in inflammatory disease research, the clinical development team, and other Takeda stakeholders. Will be accountable for defining the preclinical elements of multiple drug discovery programs, in partnership with other research leaders across Takeda and the early clinical development team within the GI and Inflammation Therapeutic Area. Will interface with the business development group to identify strategically important innovative external opportunities Will help maintain the Takeda culture that promotes creativity, open communication, collaboration, collegiality, and a high sense of urgency. Maintain the highest quality of scientific foundations of the company’s drug discovery process. Accountabilities: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified. Forms a strong partnership with clinical and commercial team colleagues for disease area strategic alignment and is accountability for formulation and delivery of mid-long term innovative strategies to build a sustainable and innovative Inflammation disease area pipeline The Director Inflammation Drug Discovery will lead a team of researchers in early target discovery through candidate selection and partner with the therapeutic area Translational team in the development and delivery of robust early development plans supporting programs through early clinical proof-of-concept. The appointee will partner with the Center for External Innovation at Takeda for the identification and assessment of external platform and pipeline opportunities and be accountable for due diligence evaluation and recommendations on external opportunities in Inflammation diseases. Is seen as an international subject matter expert and identified as a global Takeda thought leader in the field of Inflammatory disease research and keeps up up-to-date with scientific, drug discovery and development and the external competitive environment. Represents Takeda and fosters a presence in the global inflammation and immunology scientific community through scientific meetings. Ensures and encourages diversity and supports individual colleagues and their reports in career development. Ensure that all Inflammation disease area Global Product Teams are resourced for optimal scientific support for research studies, mechanistic understanding, disease area evolution and competitive landscape understanding. Provides nuanced and well-informed advice to senior stakeholders about the GI and Inflammation therapeutic landscape, providing direction on where the science will lead. Leadership Creative, collaborative, proactive and confident individual with proven leadership qualities, as demonstrated by performance. Demonstrated ability to work across functions, regions and cultures and adheres to Takeda’s values Excellent communicator, able to persuasively convey both ideas and data, orally, in presentation and written format Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Interaction Effectively navigates the dynamics of external and internal environments and leads others by creating and inspiring and engaging workplace. Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions. Innovation Creative scientific thinker with excellent understanding of emerging technologies that enhance disease understanding and human-focused drug development programs Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the disease area-specific competitive landscape Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation. Ability to take risks implementing innovative solutions, accelerating time to market. Comfortable challenging the status quo and bringing forward innovative solutions. Role models respect and inclusion, creating a culture that fosters innovation. Education & Competencies (Technical and Behavioral): PhD degree in Immunology or a closely related discipline with 10 years drug development experience in highly competitive biopharmaceutical companies or MS with 16 years experience, or BS with 18 years experience Expert scientific knowledge in autoimmune and inflammatory disease research with experience in lymphocyte biology is highly desired Highly experienced in exploratory drug development with proven biopharmaceutical industry experience leading innovative therapeutic programs and with expertise in small molecule and/or biologics drug development 10 years of direct line management and cross-functional project leadership experience required Highly knowledgeable and experienced in all aspects of Inflammation Disease drug discovery through to candidate selection/IND, including contributing to regulatory documentation. Shows cross-cultural understanding to utilize the diverse talents and has demonstrated ability to manage matrix teams to maximize the organizational productivity. Has strong leadership skills and acumen. Has excellent written and verbal communication skills in English. Capable of leading a matrixed team comprised of scientists from within Takeda as well as external collaborators. Has significant experience of participation in BD diligence activities in the preclinical discovery function ADDITIONAL INFORMATION The position will be based in Cambridge, MA . This position is currently classified as “hybrid” by Tak

Lead Scientist Drug Development - Immune Disorders (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Objective / Purpose: The GI-Drug Discovery Unit at Takeda is a team of experienced, innovative and collaborative drug discovery scientists building an industry-leading portfolio of drugs for inflammatory and GI diseases with high unmet medical need. We are seeking a leader with significant experience in building and leading biology and cross-functional drug discovery teams to establish a new group focused on chronic autoimmune diseases. The Director Inflammatory Drug Discovery Will be responsible for developing industry-leading therapeutics for patients with inflammatory diseases by leading a research group focused on drug development from target identification through to candidate selection. Will recruit, retain, and develop a large team of world class, highly innovative in vitro and in vivo research biologists focused on understanding the molecular, cellular and organ-level drivers of inflammatory disease processes, and identifying and developing drug candidates. Will be scientific research thought leader within the Drug Discovery Unit (DDU), working within a highly matrixed environment to build an industry-leading preclinical and early clinical therapeutic pipeline for Inflammatory Diseases. Will set the discovery portfolio goals for high priority autoimmune diseases and ensure alignment with key stakeholders in inflammatory disease research, the clinical development team, and other Takeda stakeholders. Will be accountable for defining the preclinical elements of multiple drug discovery programs, in partnership with other research leaders across Takeda and the early clinical development team within the GI and Inflammation Therapeutic Area. Will interface with the business development group to identify strategically important innovative external opportunities Will help maintain the Takeda culture that promotes creativity, open communication, collaboration, collegiality, and a high sense of urgency. Maintain the highest quality of scientific foundations of the company’s drug discovery process. Accountabilities: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified. Forms a strong partnership with clinical and commercial team colleagues for disease area strategic alignment and is accountability for formulation and delivery of mid-long term innovative strategies to build a sustainable and innovative Inflammation disease area pipeline The Director Inflammation Drug Discovery will lead a team of researchers in early target discovery through candidate selection and partner with the therapeutic area Translational team in the development and delivery of robust early development plans supporting programs through early clinical proof-of-concept. The appointee will partner with the Center for External Innovation at Takeda for the identification and assessment of external platform and pipeline opportunities and be accountable for due diligence evaluation and recommendations on external opportunities in Inflammation diseases. Is seen as an international subject matter expert and identified as a global Takeda thought leader in the field of Inflammatory disease research and keeps up up-to-date with scientific, drug discovery and development and the external competitive environment. Represents Takeda and fosters a presence in the global inflammation and immunology scientific community through scientific meetings. Ensures and encourages diversity and supports individual colleagues and their reports in career development. Ensure that all Inflammation disease area Global Product Teams are resourced for optimal scientific support for research studies, mechanistic understanding, disease area evolution and competitive landscape understanding. Provides nuanced and well-informed advice to senior stakeholders about the GI and Inflammation therapeutic landscape, providing direction on where the science will lead. Leadership Creative, collaborative, proactive and confident individual with proven leadership qualities, as demonstrated by performance. Demonstrated ability to work across functions, regions and cultures and adheres to Takeda’s values Excellent communicator, able to persuasively convey both ideas and data, orally, in presentation and written format Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Interaction Effectively navigates the dynamics of external and internal environments and leads others by creating and inspiring and engaging workplace. Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions. Innovation Creative scientific thinker with excellent understanding of emerging technologies that enhance disease understanding and human-focused drug development programs Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the disease area-specific competitive landscape Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation. Ability to take risks implementing innovative solutions, accelerating time to market. Comfortable challenging the status quo and bringing forward innovative solutions. Role models respect and inclusion, creating a culture that fosters innovation. Education & Competencies (Technical and Behavioral): PhD degree in Immunology or a closely related discipline with 10 years drug development experience in highly competitive biopharmaceutical companies or MS with 16 years experience, or BS with 18 years experience Expert scientific knowledge in autoimmune and inflammatory disease research with experience in lymphocyte biology is highly desired Highly experienced in exploratory drug development with proven biopharmaceutical industry experience leading innovative therapeutic programs and with expertise in small molecule and/or biologics drug development 10 years of direct line management and cross-functional project leadership experience required Highly knowledgeable and experienced in all aspects of Inflammation Disease drug discovery through to candidate selection/IND, including contributing to regulatory documentation. Shows cross-cultural understanding to utilize the diverse talents and has demonstrated ability to manage matrix teams to maximize the organizational productivity. Has strong leadership skills and acumen. Has excellent written and verbal communication skills in English. Capable of leading a matrixed team comprised of scientists from within Takeda as well as external collaborators. Has significant experience of participation in BD diligence activities in the preclinical discovery function ADDITIONAL INFORMATION The position will be based in Cambridge, MA . This position is currently classified as “hybrid” by Tak

Senior Manager, International Labeling Strategy (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. 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. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain 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 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 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 CCDS changes 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 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 CCDS 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 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; while maintaining awareness of recent in-class approvals. 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. 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. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. 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. Strong knowledge of US and EU 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 develop 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. 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: $154,400.00 - $242,550.00 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 medic

Associate Director, Global Regulatory Affairs Marketed Products (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 an Associate Director, Global Regulatory Affairs Marketed Products you will: Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Are a leader within the department and within R&D contributing to department and cross functional Takeda initiatives and influencing the field as applicable. Provide leadership/contributes as global regulatory lead (GRL) responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. How you will contribute: The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed in line with changing regulatory and business needs. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement, and communicating in a professional and timely manner. Proactively anticipates risks and develops solutions/scenario planning for identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of project(s). The Associate Director will lead all submission types. Serves as the primary FDA contact. Leads and manages FDA meetings. Responsible for demonstrating Takeda leadership behaviors. Manages junior staff as needed. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in departmental and cross-functional task-forces and initiatives. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Supports the lead regulatory reviewer in due diligence for licensing opportunities. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates solid, increasingly independent regulatory strategy skills, including an understanding of core regulatory concepts and their organizational and global implications. Proactively identifies regulatory issues and proposes creative, practical solutions and strategies, including risk mitigation. 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. 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: $154,400.00 - $242,550.00 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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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.

Associate Director, Global Labeling Lead - Driving Innovation in Therapeutic Labeling Development (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. 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. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain 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 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 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 CCDS changes 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 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 CCDS 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 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; while maintaining awareness of recent in-class approvals. 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. 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. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. 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. Strong knowledge of US and EU 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 develop 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. 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: $154,400.00 - $242,550.00 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 medic

Associate Director, Global Labeling Lead (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. 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. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain 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 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 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 CCDS changes 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 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 CCDS 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 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; while maintaining awareness of recent in-class approvals. 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. 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. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. 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. Strong knowledge of US and EU 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 develop 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. 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: $154,400.00 - $242,550.00 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 medic

Senior Maintenance Technician - Electrician (SOCIAL CIRCLE)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Utilities Technician - electrician is responsible for the operation, maintenance, and troubleshooting of plant equipment that supports utilities including but not limited to high-pressure steam boilers; chillers; heating/cooling air handling units; process wastewater treatment systems; water purification system (water softening and carbon bed filtration, reverse osmosis, continuous deionization equipment, sanitary pumps, multi-effect distillation equipment); tank mixers; air compressors and dryers; and chilled water distribution systems under minimum supervision of the utilities supervisor in rotation shift environment. Performs corrective maintenance and routine preventative maintenance on plant utilities equipment following Standard Operating Procedures (SOPs) as necessary. Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory. This senior position is responsible for performing daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies. How you will contribute: Perform preventive, corrective and predictive maintenance of all associated equipment. Operate and maintain various equipment through routine inspection and review. All work must be completed in accordance with cGMPs, SOPs, job plans, and company policies. Read, understand, and follow related SOPs and job/work plans. Ensure that forms and work order documentation are completed with accurate information. Responds to calls and conduct repairs throughout the facility. May be assigned to escort a contractor performing work on the premises. Provide support for the start-up of new equipment to ensure it meets all electrical design specifications. Repair, replace and install sensors, actuators, transformers, controllers, circuit breakers, motors, heating units, electric eyes, conduit systems, switches, defective writing, etc. Troubleshoot, repair, and replace PLCs, Servo and Frequency Drives, and related electronic hardware Disassembles, inspects, reassembles, troubleshoots, repairs, and replaces malfunctioning parts or equipment (motors, switches, sensors, input /output boards, controllers servos, gears, sprockets chains, knives, etc. using test equipment Must follow safety rules and ensure compliance with GA state and federal EPA regulations and laws. Perform Disposal of Hazardous Waste Respond to urgent and emergency work orders for the utilities department as needed. Responsible for closing assigned work orders in the CMMS (JDE, Maximo, SAP). Attend required Instructor Lead Training and planned team meetings Demonstrate continuous progress with respect to increasing job knowledge and proficiency in technical understanding/problem-solving. Keeps designated area 5S'd. (Safety, Sort, Shine, Standardize, Sustain) Ability to teach basic activities and work execution to other technicians. This position will receive general instruction on routine work with detailed instruction on new assignments. Often will be assigned to work with a less experienced, utilities or maintenance technician. Primarily interacts with Plant Engineering Department personnel. Moderate interaction with other departments. May perform other duties as assigned. What you bring to Takeda: Typically requires a high school diploma or GED plus 8 years of related industrial related experience. Pharmaceutical, utilities, and/or WWTP experience preferred. Two-year certificate in a technical field such as Electrician Proficiency in electrical circuits, schematics, servo motors, and familiarity with 460/220 3 PH wiring. HVAC, building trades or building utilities program, or equivalent military experience is preferred. 5-6 years of experience in the maintenance trades is preferred Ability to read and understand technical manuals and wiring schematics Must have good customer service skills and promote a teamwork environment Ability to effectively communicate ideas through verbal and written form. Intermediate computer skills. Ability to interact constructively with peers and other teams. Ability to seek outside resources as needed. Ability to read and understand procedures, schematics, and job blueprints. Provide a limited level of troubleshooting, diagnostic, and repair of building systems, equipment, and equipment components. Manufacturing equipment vessels, mixers, valves, and pumps. Operate general laboratory equipment to assess the analytical status of the utilities process. Familiar with CMMS, SAP, JDE, and or Maximo Must be able to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry. Familiarity with Microsoft Office Applications, SCADA, process control software, and other computer base applications Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. May be exposed to sunlight and heat. May be exposed to dust, gases, and fumes. May be required to stand and walk frequently while evaluating utilities equipment. May be around moving equipment and machinery. May climb up and into large tanks for inspection. May work in a loud area that requires hearing protection and other protective equipment to be worn. May be required to work or be assigned to a different shift as needed. Must be able to work 12-hour shifts and rotate(2/2/3) with assigned shifts. Overtime may be required at times. Requires performing activities within the plant utilities equipment, mechanical work, and computer-based activities. May be required to lift up to 50 pounds when managing chemicals. No travel is expected with this position. 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. GMSGQ ZR1 LI-MA1 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: USA - GA - Social Circle - Hwy 278 U.S. Hourly Wage Range: $27.55 - $43.26 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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 incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match

Global Regulatory Affairs Labeling Director (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. 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. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain 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 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 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 CCDS changes 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 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 CCDS 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 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; while maintaining awareness of recent in-class approvals. 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. 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. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. 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. Strong knowledge of US and EU 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 develop 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. 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: $154,400.00 - $242,550.00 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 medic

Respiratory Therapist (Non Vent)

Description: AdaptHealth Opportunity – Apply Today! At AdaptHealth we offer full-service home medical equipment products and services to empower patients to live their best lives – out of the hospital and in their homes. We are actively recruiting in your area. If you are passionate about making a profound impact on the quality of patients’ lives, please click to apply, we would love to hear from you. Respiratory Therapist This position is a NBRC credentialed professional who provides respiratory care to patients in alternate sites in accordance with AdaptHealth’s policies and procedures. Respiratory care will be preventative, rehabilitative, and palliative in nature. The Respiratory Therapist will utilize all the resources available within the agency and community to accomplish care objectives. Job Duties: Consistently demonstrates ability to adequately complete all documentation and charting procedures in compliance with ACHC and company policy and procedures. Reviews Plan of Treatments and Care Plans to assure they are accurate and up to date. Documents procedures including how the patient tolerated a procedure, side effects and other pertinent information. Assists with authorization for CPAP/BiPAP referrals for patients. Shows adequate knowledge of respiratory equipment and displays ability to utilize knowledge in the clinical setting. Demonstrates ability to effectively troubleshoot equipment in the field successfully. Maintains inventory control of CPAP/BiPAP supplies for sleep center. Displays knowledge of assessment skills and demonstrates application of clinical skills during set-ups, follow-ups, and in-services. Participates in discharge planning of highly technical cases. Performs clinical assessments as needed and reports results and recommendations to the referral and physician. Participates in highly technical discharges and prepares in advance to assure the patient and caregivers have a smooth transition to the home setting. Performs in-services to hospital staff, referrals, other professionals regarding equipment & issues of clinical nature. Follows up with physician and referrals regarding patient status and documents accurately and in a timely manner. Retain knowledge of and consistently adhere to procedures for the use of Personal Protective Equipment (PPE), infection control and hazardous materials handling. Assume on-call responsibilities during non-business hours in accordance with company policy. Maintain patient confidentiality and function within the guidelines of HIPAA. Perform other related duties as assigned. Competency, Skills and Abilities: Competent in PAP, Ventilator, Airway Clearance, and Oxygen therapy administration and management Able to perform clinical assessments and make recommendations to physicians. Equipment troubleshooting and maintenance skills. Decision making, analytical and problem-solving skills with attention to detail. Strong verbal and written communication Excellent customer service skills Ability to prioritize and manage competing priorities and tasks. Computer skills including knowledge of Microsoft Office applications Requirements: Minimum Job Qualifications: Associates degree from an AMA approved respiratory program. Valid and unrestricted RT clinical license in all states serviced by the branch, or an Associate degree in Nursing, with a valid and unrestricted LPN or RN clinical license. Must be CPR certified, One (1) year of clinical experience as a Health Care RT, HME RT or clinical nursing with Vent experience. Valid and unrestricted driver’s license AdaptHealth is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. PI8044d77a3f42-35196-40074091

SOR Pathfinder

SOR Pathfinder Help Others, Make a Difference, Save a Life. Do you want to make a difference in people's lives every day? Or help people navigate the tough spots in their life? And do it all while working where your hard work is appreciated? You have a lot of choices in where you work…make the decision to work where you are valued! Join the McNabb Center Team as the SOR Pathfinder today! The SOR Pathfinder Job Summary The SOR Pathfinder serves as a member of the multi-disciplinary team providing direct engagement, assessment, referral, and on-going follow up with clients. Able to complete assessments and other required documents (C-SSRS, GPRAs, etc.), track referrals, and complete updates. Maintains positive connections to internal and external stakeholders and referral sources. Has excellent verbal, written, and computer skills. Must be legally able to operate and willing to use personal vehicle in the performance of job-related duties. Has a strong desire to work with individuals in substance use treatment and recovery with respectful understanding of multiple paths to recovery. This job description is not intended to be all inclusive; and employee will also perform other reasonable related job responsibilities as assigned by immediate supervisor and other management as required. This organization reserves the right to revise or change job duties as the need arises. Moreover, management reserves the right to change job descriptions, job duties, or working schedules based on their duty to accommodate individuals with disabilities. This job description does not constitute a written or implied contract of employment. 1. Daily Staff Duties. Ability to exercise sound judgment and effective decision-making and demonstrates non-judgmental support 1:1 with individuals and families around substance use disorder treatment and harm reduction. Keeps up to date on knowledge of community resources and referral processes to assist clients in setting and meeting goals and objectives (i.e., service planning around client needs). Ability to assess client functioning and level of need utilizing ASIs, and ASAMS and standard practice modalities as required. Provides effective and ethical 1:1 support by utilizing motivational interviewing and other approved best practice strategies or industry standards of care. Is an empathic listener and demonstrates flexibility in working with diverse populations with a strong interest in working with individuals with substance use and co-occurring issues. Responds to all messages, emails, and voicemails within 24 hours. Completes documentation and other tasks as assigned by supervisor before the end of each shift. Provides coverage for caseload coverage to ensure services continue when on leave. 2. Complete all required documentation within designated time frames. Ensures that documentation is completed accurately within required time frames: including, but not limited to Releases of Information, consents, referrals, and notes within TN-Wits, Centricity or other record as assigned. Responsible for completing Government Performance and Results (GPRAs) at three required time frames with program participants with a completion rate of 80% or greater. Arranges with supervisor a coverage plan to ensure services continue when team member is on leave or unavoidably unavailable to a specific client or clients. Completes logs, screening, follow up and any other required or requested tools accurately and on time, including closing and discharge documentation. Assists Team Leader with data ensuring program evaluation, quality assurance, and improvement indicators, and client satisfaction are regularly and accurately reflected. Keeps all private and/or confidential information in secure location or in approved locked HRMC bags and follows HIPAA and 42CFRPart2 regulations in all circumstances. Stays current on all required relias training, CPR, and First Aid certifications as well as verbal and physical de-escalation skills training. Ensures time sheets and other requirements are up-to-date and accurate. 3. Functions as a member of a multi-disciplinary team. Ability to present professionally and work within multi-disciplinary teams as a positive McNabb Center employee and community ambassador representing the client, program, and agency. Ability to set and maintain appropriate boundaries for quality service delivery and healthy self-care. Must be punctual and maintain good attendance. Maintains healthy two-way communication in person, by telephone, and within writing to effectively serve clients. Demonstrates willingness to promote a harmonious work environment by maintaining a positive and professional working relationship with all staff members, supervisors, and other internal and external stakeholders. Communicates and approaches conflict in a professional way with a problem-solving, win/win outcome as the goal. Possesses flexibility and is able to work independently in multiple locations in a variety of settings. COMPENSATION: Starting salary for this position is approximately $18.98/hr based on relevant experience and education. QUALIFICATIONS - SOR Pathfinder Experience / Education: Must have a Bachelor's degree in Counseling, Addictions, Social Work or other related field with two years of experience working with the population. Should have broad knowledge and understanding of Motivational Interviewing, stages of change, harm reduction and best practices regarding substance use disorder treatment and recovery. Must have experience and understanding in the areas of cultural diversity, human development, and treatment of substance use disorder, understanding of trauma-informed care, suicide prevention, crisis referral and extensive knowledge of community resources. Experience working with special populations including individuals with co-occurring disorders, substance use disorders and mental health disorders. Computer expertise is required as timesheets, training modules, email, and some program documentation are computer-based. Regular attendance is an essential job function. Must have an F-endorsement and be able to legally operate personal vehicle during the performance of job duties. Physical: Possible exposure to biological hazards. Lifting up to 50 lbs. Pushing/pulling up to 150 lbs. Frequent sitting, standing, walking, bending, stooping, and reaching. Location: Knox County, Tennessee Apply today to work where we care about you as an employee and where your hard work makes a difference! Helen Ross McNabb Center is an Equal Opportunity Employer. The Center provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment. Helen Ross McNabb Center conducts background checks, driver's license record, degree verification, and drug screens at hire. Employment is contingent upon clean drug screen, background check, and driving record. Additionally, certain programs are subject to TB Screening and/or testing. Bilingual applicants are encouraged to apply. PI80abf542a208-35196-35909830