Food

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.

  • Cambridgeport, MA

  • no content

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.

  • Cambridgeport, MA

  • no content

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

  • Cambridgeport, MA

  • no content

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

  • Cambridgeport, MA

  • no content

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

  • Boston, MA

  • no content

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.

  • Cambridgeport, MA

  • no content

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

  • Boston, MA

  • no content

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

  • Boston, MA

  • no content

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

  • Boston, MA

  • no content

CDL-A Driver Home Most Nights

CDL-A Local Drivers - Rome, GA Earn $1,200 - $1,400 Weekly Home Throughout the Week Drop & Hook Text APPLY to to get your quick app started! Brown Trucking is hiring CDL-A Local Drivers in Rome, GA. Enjoy reliable home time, strong weekly pay, and a company built around supporting drivers for long-term success. CDL-A Local Driver Highlights Drivers earn $1,200 - $1,400 weekly, with higher earning potential available. Home throughout the week Weekend work available to increase earning potential Mostly drop & hook freight Driver Incentives: Get paid for surveys, safety meetings, and clean inspections Refer a friend and earn $3,000 (paid within 90 days) Paid vacation, holidays, and orientation Low-cost benefits after 60 days 401(k): Company match up to 4% with a 5% employee contribution Weekly deposits 100% vested Driver Requirements Valid Class A CDL 12 months of verifiable experience within the last 36 months Clean MVR No DWI/DUI in the last 7 years Why Drive for Brown? The Brown Trucking driver experience is unique in every way! From incredibly flexible home time to unmatched dispatcher support and competitive weekly pay, our drivers are given the resources to excel on their own terms-both on AND off the road. Your transportation career deserves to call Brown home. Apply today or text APPLY to

  • Tanner, AL

  • no content

RN - Registered Nurse - Neuroscience ICU

Job Summary Geisinger is proud to offer a full time Inpatient RN up to $21,500 hiring incentive for eligible candidates! $41 minimum hiring rate with increased rates for experienced individuals and up to $7 shift differentials for evening, night, and weekend shifts. Relocation assistance for eligible candidates! Join the Geisinger Family! Apply now! To learn more about Geisinger opportunities, please contact Katy Baralt, Nurse Recruiter, at [email protected]. Job Duties Assesses plans, organizes, performs, and evaluates nursing activities to meet the needs of the patient. Promotes adaptive responses of patient and family to achieve the highest level of patient care, promote safety, and maximize patient satisfaction. Exhibits compassionate care during patient-nurse interactions. Coordinates patient care and interaction of staff. Meets the qualifications to provide care for patients in their assigned nursing unit. Responsible for ensuring the very best patient and family experience by optimizing all interactions. Completes assessments as established by scope of practice and unit standards. Addresses physical, psychological, social, cultural, and spiritual needs of patient and family throughout the continuum of care. Formulates, coordinates, and provides plan of care as established in unit standards including, patient and family education, family needs and discharge planning throughout hospitalization with members of the interdisciplinary team. Provides direct patient care including, treatments, medications, and diagnostic studies according to policy and procedure. Evaluates effectiveness of nursing interventions and revises plan of care based upon patient response to interventions. Initiates collaboration with physicians, ancillary personnel, and other interdisciplinary team members and acts to proactively resolve and facilitate patient needs. Problem solves, troubleshoots and takes corrective measures in the care and handling of equipment. Participates in unit-based decision-making regarding the utilization of evidence- based practice. Actively participates as a team member working toward team goals of the unit and organization and is accountable for unit and system specific metrics. Actively participates in patient quality and safety education programs and other activities designed to improve departmental and organizational quality and safety. Work is typically performed in a clinical environment. Accountable for satisfying all job specific obligations and complying with all organization policies and procedures. The specific statements in this profile are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job. Additional competencies and skills outlined in any department-specific orientation will be considered essential to the performance of the job related to that position. Position Details Schedule Details: full time, 36 hours per week, day/night rotation, every other weekend and every other holiday. We offer self-scheduling that is modified by a scheduling committee to meet the needs of the unit. Unit Details: Neuroscience ICU is an 18 bed critical care unit with primary focus being on the neurosurgery and neurology patient populations. Collaborative, multi-disciplinary approach to patient care, utilizing nursing, physician, respiratory therapy, and ancillary staff members to perform at the highest standard. The NSICU will offer cutting edge neurosurgery technologies and innovations in a fast-paced environment. We offer self-scheduling that is modified by a scheduling committee to meet the needs of the unit. Unit is operationalized in shared governance, giving autonomy to charge nurses and unit staff to make decisions that directly impact professional practice and day-to-day operations. Staff are supported by the Operations Manager, two Team Coordinators, and two Clinical Nurse Educators. Seeking candidates who wish to make an impact with patients, families, and peers, and are strongly internally motivated to succeed in their professional development. We are looking for candidates who can critically think to make quick decisions, while remaining calm during stressful situations; someone who is detail-oriented, but able to see the bigger picture. Integrity and the ability to self-report mistakes or errors without fear of being reprimanded is a must. Never be afraid to ask questions and understand the “why”. Geisinger Medical Center is proud to receive ANCC Magnet Recognition®, the highest and most prestigious distinction a health care organization can receive for nursing practice and quality patient care. Benefits of working at Geisinger: Full benefits (health, dental and vision) starting on day one Three medical plan choices, including an expanded network for out-of-area employees and dependents Pre-tax savings plans with healthcare and dependent care flexible spending accounts (FSA) and a health savings account (HSA) Company-paid life insurance, short-term disability, and long-term disability coverage 401(k) plan that includes automatic Geisinger contributions Generous paid time off (PTO) plan that allows you to accrue time quickly Up to $5,000 in tuition reimbursement per calendar year MyHealth Rewards wellness program to improve your health while earning a financial incentive Family-friendly support including adoption and fertility assistance, parental leave pay, military leave pay and a free Care.com membership with discounted backup care for your loved ones Employee Assistance Program (EAP): Referrals for childcare, eldercare, & pet care; Access free legal guidance, mental health visits, work-life support, digital self-help tools and more Voluntary benefits including accident, critical illness, hospital indemnity insurance, identity theft protection, universal life and pet and legal insurance The ability to work under a Temporary Practice Permit until you take NCLEX Shared governance structure that empowers our nurses Professional opportunities for growth and advancement Support and mentorship from a full range of dedicated nursing leaders Community involvement through our Employee Resource Groups Employee referral incentive program Geisinger values and prioritizes the safety and security of our staff by investing in a Strongline Alert Notification system worn by our staff, robust camera surveillance system, metal detectors at certain locations and security guards/K9 program on campus. Education Graduate from Specialty Training Program-Nursing (Required) About Geisinger OUR PURPOSE & VALUES: Everything we do is about caring for our patients, our members, our students, our Geisinger family and our communities. KINDNESS: We strive to treat everyone as we would hope to be treated ourselves. EXCELLENCE: We treasure colleagues who humbly strive for excellence. LEARNING: We share our knowledge with the best and brightest to better prepare the caregivers for tomorrow. INNOVATION: We constantly seek new and better ways to care for our patients, our members, our community, and the nation. SAFETY: We provide a safe environment for our patients and members and the Geisinger family We offer healthcare benefits for full time and part time positions from day one, including vision, dental and domestic partners. Perhaps just as important, from senior management on down, we encourage an atmosphere of collaboration, cooperation and collegiality. We know that a diverse workforce with unique experiences and backgrounds makes our team stronger. Our patients, members and community come from a wide variety of backgrounds, and it takes a diverse workforce to make better health easier for all. We are proud to be an affirmative action, equal opportunity employer and all qualified applicants will receive consideration for employment regardless to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.

  • Danville, PA

  • no content

RN-Registered Nurse-Advanced Acute Care Neurosciences

Job Summary Geisinger is proud to offer a full time Inpatient RN up to $24,000 hiring incentive for eligible candidates! $41.50 minimum hiring rate with increased rates for experienced individuals and up to $7 shift differentials for evening, night, and weekend shifts. Relocation assistance for eligible candidates. Unit Location: AGP4 Job Duties Assesses plans, organizes, performs, and evaluates nursing activities to meet the needs of the patient. Promotes adaptive responses of patient and family to achieve the highest level of patient care, promote safety, and maximize patient satisfaction. Exhibits compassionate care during patient-nurse interactions. Coordinates patient care and interaction of staff. Meets the qualifications to provide care for patients in their assigned nursing unit. Responsible for ensuring the very best patient and family experience by optimizing all interactions. Completes assessments as established by scope of practice and unit standards. Addresses physical, psychological, social, cultural, and spiritual needs of patient and family throughout the continuum of care. Formulates, coordinates, and provides plan of care as established in unit standards including, patient and family education, family needs and discharge planning throughout hospitalization with members of the interdisciplinary team. Provides direct patient care including, treatments, medications, and diagnostic studies according to policy and procedure. Evaluates effectiveness of nursing interventions and revises plan of care based upon patient response to interventions. Initiates collaboration with physicians, ancillary personnel, and other interdisciplinary team members and acts to proactively resolve and facilitate patient needs. Problem solves, troubleshoots and takes corrective measures in the care and handling of equipment. Participates in unit-based decision-making regarding the utilization of evidence- based practice. Actively participates as a team member working toward team goals of the unit and organization and is accountable for unit and system specific metrics. Actively participates in patient quality and safety education programs and other activities designed to improve departmental and organizational quality and safety. Work is typically performed in a clinical environment. Accountable for satisfying all job specific obligations and complying with all organization policies and procedures. The specific statements in this profile are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job. Additional competencies and skills outlined in any department-specific orientation will be considered essential to the performance of the job related to that position. Benefits of working at Geisinger: Full benefits (health, dental and vision) starting on day one Three medical plan choices, including an expanded network for out-of-area employees and dependents Pre-tax savings plans with healthcare and dependent care flexible spending accounts (FSA) and a health savings account (HSA) Company-paid life insurance, short-term disability, and long-term disability coverage 401(k) plan that includes automatic Geisinger contributions Generous paid time off (PTO) plan that allows you to accrue time quickly Up to $5,000 in tuition reimbursement per calendar year MyHealth Rewards wellness program to improve your health while earning a financial incentive Family-friendly support including adoption and fertility assistance, parental leave pay, military leave pay and a free Care.com membership with discounted backup care for your loved ones Employee Assistance Program (EAP): Referrals for childcare, eldercare, & pet care; Access free legal guidance, mental health visits, work-life support, digital self-help tools and more Voluntary benefits including accident, critical illness, hospital indemnity insurance, identity theft protection, universal life and pet and legal insurance The ability to work under a Temporary Practice Permit until you take NCLEX Shared governance structure that empowers our nurses Professional opportunities for growth and advancement Support and mentorship from a full range of dedicated nursing leaders Community involvement through our Employee Resource Groups Employee referral incentive program Geisinger values and prioritizes the safety and security of our staff by investing in a Strongline Alert Notification system worn by our staff, robust camera surveillance system, metal detectors at certain locations and security guards/K9 program on campus. Join the Geisinger Family! Apply now! To learn more about Geisinger opportunities, please contact Courtney Sassaman, Nurse Recruiter, at [email protected]. Position Details AGP4 is a 27 bed unit that has a major focus on the neurosciences. Neurosurgery patients can include craniotomies, cervical and lumbar surgeries, as well as brain and spinal tumors. The focus in neurology can vary from stroke/TIA’s to neuromuscular disorders, Guillain-Barré syndrome, MS and chronic migraines. There is a 6-bed epilepsy unit that utilizes continuous EEG monitoring for our seizure patients and their needs. The nursing staff is also flexible enough to navigate and take care of other medical/surgical and telemetry patients. This patient population can range from chronic COPD and CHF patients to GI Bleed, orthopedic, general surgery and trauma patients. Schedule is 0.9 FTE (36 hours). Nights. Every other weekend/Every other holiday rotation. G eisinger Medical Center is proud to receive ANCC Magnet Recognition®, the highest and most prestigious distinction a health care organization can receive for nursing practice and quality patient care. Education Graduate from Specialty Training Program-Nursing (Required), Bachelor's Degree-Nursing (Preferred) About Geisinger OUR PURPOSE & VALUES: Everything we do is about caring for our patients, our members, our students, our Geisinger family and our communities. KINDNESS: We strive to treat everyone as we would hope to be treated ourselves. EXCELLENCE: We treasure colleagues who humbly strive for excellence. LEARNING: We share our knowledge with the best and brightest to better prepare the caregivers for tomorrow. INNOVATION: We constantly seek new and better ways to care for our patients, our members, our community, and the nation. SAFETY: We provide a safe environment for our patients and members and the Geisinger family We offer healthcare benefits for full time and part time positions from day one, including vision, dental and domestic partners. Perhaps just as important, from senior management on down, we encourage an atmosphere of collaboration, cooperation and collegiality. We know that a diverse workforce with unique experiences and backgrounds makes our team stronger. Our patients, members and community come from a wide variety of backgrounds, and it takes a diverse workforce to make better health easier for all. We are proud to be an affirmative action, equal opportunity employer and all qualified applicants will receive consideration for employment regardless to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.

  • Danville, PA

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