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 medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Join a dedicated, high‑performing start‑up team supporting a single key client in the delivery of UK clinical trial submissions. In this role, you will take ownership of country‑level regulatory activities, from initial CTA preparation through ongoing maintenance, amendments, and safety‑related submissions. Working closely with the client’s Clinical Operations Managers, you’ll play a critical part in meeting their stringent KPIs, ensuring accuracy, compliance, and timely delivery of all regulatory milestones. What You’ll Do - Lead UK country‑level submission activities for initial Clinical Trial Applications (CTAs), ensuring high‑quality, complete, and compliant packages. - Manage ongoing maintenance submissions, including substantial and non‑substantial amendments, ensuring all updates are submitted within required timelines. - Support relevant safety‑reporting activities in line with regulatory expectations and client requirements. - Collaborate closely with the client’s Clinical Operations Managers to help achieve key performance indicators and operational targets. - Maintain meticulous tracking of all submission activities, timelines, and status updates across multiple systems and trackers. - Package, file, and archive submission documents and all related correspondence according to the client’s standards and SOPs. - Partner with cross‑functional teams and UK authorities (e.g., MHRA, REC) to support efficient and timely processing of applications. - Provide expert review of regulatory documentation, ensuring consistency, accuracy, and high‑quality submissions. What You Bring - 1–2+ years’ experience in UK clinical trial start‑up, with hands‑on experience submitting UK ‘country‑level’ CTIMPs to all applicable UK regulatory bodies and a solid understanding of the UK CTA pathway. - Practical experience preparing Clinical Trial Applications, Amendments, and Safety Reporting, with an advantage for candidates competent in completing the Medicines Information Form (MIF)—accurately detailing Investigational Medicinal Products (IMPs) alongside the required ethics information. - Solid knowledge of ICH‑GCP, UK clinical trial regulations, and EC/IRB/MHRA submission processes. - Proven ability to manage a high‑volume workload, juggle competing deadlines, and maintain detailed tracking with accuracy. - Strong organisation, attention to detail, and confidence in managing communication with client representatives, investigator site teams, and regulatory authorities. - A proactive, solutions‑focused approach with the ability to identify risks early and keep studies inspection‑ready. Learn more about our EEO & Accommodations request here.

Document Coordinator III Location: (Remote) Stuart, FL, United States Job Description: Job Description Summary As Document Coordinator III, you will obtain the necessary documentation from physicians to substantiate a patient's need for medical supplies for submission to their insurance. This position is eligible for a monthly incentive program and a Sign-On Bonus. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Our vision for Interventional Urology and Critical Care at BD Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting and Home Care. Key responsibilities will include: - Contacts physician office staff via phone, fax, and/or e-mailed to obtain medical documentation - Develops and maintains knowledge in Medical Supplies and/or Insurance Guidelines - Able to identify and professionally resolve customer service- related issues - Works in conjunction with Sales Operations to identify and support customer service- related initiatives as defined by company goals and objectives - Meets or exceeds daily, weekly, and monthly inbound or outbound call goals in conjunction with productivity measurements as communicated by direct supervisors - Adheres to phone activity/compliance standards to include Medicare guidelines, HIPAA, ACW, and minimum call volumes - Tracks daily production and submits daily sales logs to direct supervisor - Ability to work within Special Projects, Progress Notes, and/or Service Ticket Team as business needs require About you: To be successful in this role, you require: - Minimum High School Diploma or general education degree (GED) - Minimum 1 year call center or customer service experience. Medical Industry experience is preferred - Ability to read, analyze, and interpret medical supply publications, technical procedures, and/or training tools, write internal and external business correspondence and effectively present information and respond to questions from management, team members, and/or customers - Ability to apply intermediate math skills and calculate figures and amounts such as discounts, interest, commissions, proportions, and percentages - Ability to solve practical problems and deal with a variety of variables and to interpret a variety of instructions furnished in written, oral, diagram, or schedule form - Advanced analytical reasoning including the ability to forecast exponentials within workflow processes and reason against outside factors - Knowledge of Microsoft Office Applications; Ability to utilize call center telecommunications software - Shift requirement: must be able to work late shift 9:30 AM- 5:30 PM EST 1x a week; all other days, first shift, EST. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit https://bd.com/careers Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

• Owner of interdepartmental coordination for monitoring and preparing submissions for Utilization Review (UR) state licenses • Work closely with legal and other industry resources for regulatory research • Collaborate with internal/external stakeholders for compliance information • Support Sr. Director in developing quality improvement and utilization management initiatives • Documenting and tracking all licensing requirements and application statuses • Coordinate with legal to monitor state licensing requirements • Assist with implementing quality improvement initiatives and maintaining RBUM policies • Support accreditation program standards and client audits