Sebela Pharmaceuticals jobs

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role The Principal Manager, R&D GMP Pharmaceutical Sciences Quality EU & US provides Quality oversight across Takeda's investigational medicinal product development lifecycle, from early clinical development through commercialization. You will support diverse and often complex programs, including biologics, synthetic molecules, plasma-derived therapies, cross-modality conjugates, combination products, and new modalities. The role requires independent decision-making, strong cross-functional collaboration, and the ability to work with multiple CMOs and partnership organizations to ensure cGMP compliance, product integrity, and timely progression of development programs. How you will contribute * Oversee final release and disposition of Clinical Trial Material across multiple modalities and complex development programs. * Review and approve batch documentation, master/executed records, labels, specifications, analytical methods, protocols, and stability plans. * Ensure deviations, Out of Specification/Out of Trend, complaints, and other quality issues are fully investigated and addressed with effective CAPAs. * Collaborate closely with Pharmaceutical Sciences, Global Clinical Supply Chain, and other partners to resolve quality events. * Identify applicable regulations, assess compliance gaps, and propose solutions to maintain cGMP compliance. * Serve as GMP QA authority for Pharm Science Teams and provide strategic quality guidance internally and to CMOs/partners. * Support or lead continuous improvement initiatives that enhance R&D GMP Quality processes and operational efficiency. * Contribute technical quality content to regulatory filings and collaborate with CMC submission teams. * Participate as SME in external audits, support PAI readiness, and contribute to supplier qualification and Quality Technical Agreements. * Build strong cross-functional relationships to enable agile pharmaceutical development and high-quality outcomes. What you bring to Takeda * Bachelor's degree in a relevant scientific field required; advanced degree preferred, with 5+ years of increasing responsibility in manufacturing, QC/QA, or compliance. * Comprehensive understanding of international pharmaceutical regulations and their application to cGMP development activities. * Proven ability to critically review manufacturing documentation for compliance with procedures, regulations, and regulatory filings. * Strong problem-solving skills with the ability to anticipate issues and drive proactive, practical solutions. * Experience working effectively in global, matrixed environments with the ability to influence cross-functional stakeholders. * Excellent communication and interpersonal skills, with professional experience interacting with CMOs, suppliers, and testing labs. * Demonstrated ability to negotiate complex issues and reach constructive, compliant resolutions. * Ability to mentor, guide, and share expertise to strengthen team capabilities. * High attention to detail and solid organizational skills, with the ability to manage multiple priorities independently. * Willingness to travel approximately 10% domestically and internationally and to operate in both office and manufacturing/lab environments. 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. Empowering our people to shine: 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, or any other characteristic protected by law. 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: Lexington, MA U.S. Base Salary Range: $111,800.00 - $175,670.00 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 Lexington, MA 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.

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** Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative pharmacology & translational sciences, statistics, programming, outcomes research and epidemiology, and patient safety & pharmacovigilance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of QPTS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with other functional experts such as DMPK&M, TB&B, and Pharmacometrics to drive a MIDD path within each project, ensuring that mechanistic understanding through systems pharmacology and biomarker insights informs clinical development strategies. Position Objectives: + Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Drives the integration of biological, pharmacological, and clinical insights and possesses primary responsibility for dosage selection and generation of causality evidence across the drug development continuum. + Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives. + Explores and excels in synergistic relationships with experts in translational sciences, digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines. + Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications. **Accountabilities:** + Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams. + Collaborates cross-functionally with discovery, toxicology, and other QPTS functions to ensure that preclinical findings are effectively translated into clinical biomarker plans and exploratory endpoints. + Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK). + Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and is responsible for clinical pharmacology summary documents for regulatory submissions. + Oversees and/or independently performs PK, PD, and pharmacometric analyses, including the interpretation of PK/PD data in close partnership with DSI and external partners. + Maintains a high standard for good clinical practice, compliance, and ethics. + Provides mentorship to junior staff, acts as a cross-functional leader and may manage a sub-team within a TA. + Participates as a member of Business Development due diligence, when requested. + Leads infrastructure initiatives and/ or cross-functional best practice initiatives. + Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline, such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA. **Education & Competencies (Technical and Behavioral):** + Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD + MS with 12+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD _Desired technical skills:_ + Extensive knowledge and experience with design, analysis, and reporting of clinical pharmacology studies. + Specialized clinical pharmacology expertise in multiple therapeutic areas, development phases, and/or different regions. + Experience with translational studies, disease-relevant models, and biomarker plans to support clinical translation and early clinical development strategy. + Experience in leading and driving the scoping and implementation of MIDD within projects. + Hands-on expertise/knowledge in application of advanced knowledge in integration of multiple data sources (PK/PD/Efficacy/Safety/biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial design, and quantitative decision making. + Experience in regulatory submission and approvals of at least one original/major NDA/CTDs or multiple supplemental NDA/CTDs (global or regional). + Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant development milestones such as EoP2, pre-submission, and pediatric development plan (PIP and PWR). + Strong knowledge of allied fields critical for drug development, such as statistics, drug metabolism, pharmacology, toxicology, bioanalysis, and pharmaceutical science. + Ability to evaluate Benefit-Risk associated with project decisions, effectively manage GPT expectations, and influence TA strategies. + Leadership in cross functional decision to optimize the likelihood of drug R&D success and utilization of the quantitative decision-making framework. + Drives for efficiency using innovative processes and methodologies. + Accelerates regional development and filings through innovation (regional QCP). _Desired behavioral competencies:_ + Independently executes QCP deliverables and provides solutions to complex issues. + Consistently delivers with high quality and efficiency. + Elevates knowledge and enhances capability of others. + Communicates effectively and influences in cross-functional teams. + Inspires commitment and enables cross-function collaboration. + Communicates success stories and shares learning across QCP. + Focuses on priorities and delivers on commitments. This position is currently classified as "hybrid" by 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:** USA - MA - Cambridge - Kendall Square - 500 **U.S. Base Salary Range:** $174,500.00 - $274,230.00 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** USA - MA - Cambridge - Kendall Square - 500 **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.

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 RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. Oversees and provides regulatory operational support for programs in the Therapeutic Area Unit (TAU). Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning . The intern will support the Gastrointestinal (GI) Global Regulatory Project Management & Strategic Planning (RPM&SP) group in advancing regulatory milestones. This role will provide hands-on experience in health authority meeting planning, developing submission timelines, and supporting scenario planning for key regulatory deliverables. How You Will Contribute: The RPM&SP intern will provide valuable support in developing timelines, scenario analyses, and health authority meeting logistics-activities that directly impact the group's ability to meet regulatory milestones efficiently. The intern contribution will help in assisting the lead RPM to focus on strategy while ensuring operational excellence. In addition, the intern's fresh perspective and analytical work will enhance the team's ability to anticipate challenges and optimize submission planning Responsibilities: Assist in planning and logistics for health authority (HA) meetings, including preparation of timelines, coordination of materials, and tracking key actions. Support the development of submission timelines and scenario analyses to evaluate regulatory strategy options. Contribute to the preparation of regulatory documentation and project tracking tools. Internship Development Opportunities: The intern will gain hands-on exposure to the regulatory strategy and operations function within Takeda's GI therapeutic area. By supporting health authority meeting preparation and submission planning, the intern will learn how cross-functional teams collaborate to advance innovative therapies through regulatory milestones. This role provides practical project management and regulatory operations experience that builds a strong foundation for a career in global drug development. Job Requirements: This position will be Fully Remote Currently pursuing a Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Pharmacy, or related field. Strong organizational, analytical, and communication skills. Interest in regulatory strategy, drug development, and project management. Proficiency with Microsoft Office (Excel, PowerPoint, Project/Timeline tools a plus). Internship Eligibility Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship Must be currently enrolled in a degree program graduating December 2026 or later The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) The intern must be able to commit to one of these time frames Able to work full time 40 hours a week during internship dates Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: Hands-on experience with real projects and responsibilities Dedicated mentorship program pairing interns with experienced professionals Networking opportunities with industry professionals and fellow interns Internship events focused on professional and skills development Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. 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. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: Paid sick time Civic Duty paid time off Participation at company volunteer events Participation at company sponsored special events Access to on-site fitness center (where available) Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypePaid Intern (Fixed Term) (Trainee) Time TypeFull time Job Exempt NoIt 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.

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 DescriptionAbout the role: As a member of Takeda Oncology your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Patient Value and Access team, you will report to the Contracting Operations Lead and work with key stakeholders. Perform calculations and generate payments in compliance with executed reimbursement Agreements and maintain all assigned account responsibilities. Assist in the identification and development of information and process requirements. Consult with managers and key stakeholders to make well-informed decisions, drive process improvement and other initiatives. Provide support for data governance, business process management, and assist in the performance and maintenance of controls, data quality, and accuracy. Understand business and operational strategies and processes, respond to data requests with appropriate information and analysis. Respond to routine business, systems, and data questions, and assist the team with problem resolution. Assist as needed with routine variance analysis to ensure data completeness and payment accuracy. Conduct research and provide training and guidance as needed. Provide support for the management and coordination of data and information resources. Maintain an inventory of policy, procedure, training, and other documentation. Support the development of standard reporting and other metrics as required. Support all compliance and audit reviews. Coordinate resources to support for cross-functional projects and activities. How you will contribute: Perform all the functions required for the management and administration of assigned accounts. Ensures all pertinent contract attributes are properly translated into the correct contract set-up in the rebate payment system. Ensures the accuracy, integrity, and timeliness of all payments for Commercial and Medicare Part D contracted customers, including rebates, fees and chargebacks. This process includes the interpretation and translation of contract language, ensuring formulary/benefit compliance, data validation and rebate calculations. Adhere to all audit requirements and any/all reporting regulations as defined within Takeda's policies and guidelines related to rebate processing. Gain a thorough understanding of contract terms and requirements and respond to non-routine questions and data problems. Coordinate with internal teams to bring all issues to a satisfactory resolution. Gather Payer claim level data files, reconcile Payer invoices and perform detailed payment analysis to ensure contract compliance and rebate payment accuracy. GPO roster reconciliation, GPO sales volume reconciliation, run superlist performance reports, and calculate rebates. Maintain trading partners and process rebates and fees within ModelN FLEX revenue management system for both Payer and GPO contracts. Support data requests from US OBU Patient Value & Access field team, Distribution, Data Stewards, and IT, as well as external parties including Payers and GPOs. Supports all Commercial and Medicare Part D internal/external audits by preparing and providing the necessary documentation to Director, Commercial Contracting Operations Assists with the implementation of system and/or process improvements to develop more efficient business processes. Provide production support testing of new system enhancements, defects or new programs. Performs all system user acceptance testing for any systems that support the rebate payment process. This also includes working with IT on updating test scripts. Assists Commercial Contracting Managers with updating rebate training manual and other supporting materials (i.e., quality control checklists). Minimum Qualifications/Requirements: Bachelor's degree or 4 years contracts and pricing experience required. 2+ years of rebate processing experience in the pharmaceutical industry required. ModelN/Flex Revenue Manager experience in contract implementation and maintenance preferred. Experience with various commercial contracting price protection methodologies preferred. Ability to think through how decisions will impact Takeda, customers and stakeholders prior to execution. Strong critical thinking and problem solving skills. Strong verbal and written communication skills. Must demonstrate excellent organization and time-management skills. Ability to handle multiple projects and tasks in a matrix environment. 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: $111,800.00 - $175,670.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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 Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. Phlebotomist About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will greet donors as they enter and exit the donor floor. · You will perform venipuncture of donors and programming of plasmapheresis machine. · You will monitor donors during the donation process and manage donor reactions. · You will perform all tasks required for the setup, verification, operation, and troubleshooting of plasmapheresis equipment within scope of training. · You will install, prime, and disconnect disposable sets on the plasmapheresis machines · You will stock supplies, break down empty cartons and assist with proper disposal. · You will take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system. · You will perform finger sticks, test sample, and record other donor measures to include hematocrit, total protein, and weight. · You will enter donor information into the Donor Information System (DIS). · You will coordinate donors to donor floor and compensate donors using the Debit Card system. · You will support the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes through use of company approved procedures including 5S, Value Stream Mapping and Kaizen. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment. 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 provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - OH - Columbus - Bethel Rd U.S. Starting Hourly Wage: $17.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, 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. LocationsUSA - OH - Columbus - Bethel RdWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time Job Exempt No

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 As Director, Global Quality Systems (DMS & LMS), you will serve as the enterprise Business System Owner for Takeda's Document Management System (DMS) and Learning Management System (LMS). You you will drive the design, implementation, and deployment of the DMS & LMS electronic systems. You will be expected to navigate highly complex, cross-functional challenges-balancing compliance, business needs, and technological innovation-while remaining sufficiently hands-on to understand system configurations, investigate issues, and support end users when needed. As the business owner of these critical quality systems, you will play an essential part in advancing Takeda's digital quality landscape. Takeda is fully leaning into the capabilities and promise of AI and digital advancement, and we are looking for a Director who is motivated by exploring innovation within the pharmaceutical environment. Your leadership will help transform our Global Quality organization by encouraging innovative thinking and delivering scalable, future-ready digital solutions. How you will contribute Lead the implementation, enhancement, and lifecycle management of enterprise DMS and LMS solutions, ensuring alignment with global standards, GxP requirements, and Takeda's quality management framework. Provide senior leadership for highly complex issues, acting as the primary escalation point for systemic problems, inspection/audit observations, and cross-functional decision making related to DMS and LMS. Translate business needs into robust technical and process solutions, collaborating closely with IT, Quality, Manufacturing, R&D, and Commercial to design efficient, compliant workflows and integrations. Maintain a strong hands-on understanding of the systems, including configuration, data structures, user roles, and interfaces, enabling you to guide troubleshooting, support complex user issues, and validate technical proposals. Define and govern business processes and procedures related to document and learning management, ensuring effective system integration, regulatory controls, training curricula, and data integrity. Lead change at enterprise scale, leading change management initiatives, major system upgrades, and migrations/retirements, and ensuring that business needs, data requirements, and impact on users are fully addressed. Establish and oversee governance forums and user communities, fostering knowledge sharing, user engagement, and continuous improvement through regular meetings, communications, and feedback loops. Monitor and continuously improve system performance and inspection readiness, using metrics and analytics to proactively address risks, strengthen compliance, and enhance user experience. Drive digital innovation and automation, partnering with internal and external experts to explore AI, advanced analytics, and other emerging technologies that can modernize quality practices and reduce manual effort. Represent Global Quality Systems with senior stakeholders, aligning priorities, managing expectations, and influencing decisions that affect Takeda's global quality and digital ecosystem. What you bring to Takeda A strategic, innovative mindset with the ability to shape and execute a long-term vision for global quality systems while delivering tangible, short-term improvements. Extensive experience in the pharmaceutical or biotech industry, with deep knowledge of GxP regulations, global quality standards, and inspection expectations related to document and learning management. Proven leadership in enterprise-level DMS and/or LMS ownership, including strategy, implementation, and ongoing governance. Ability to operate at both strategic and hands-on levels-comfortable engaging with senior leaders on risk and investment decisions, and equally comfortable diving into system details, data issues, and complex user problems. Strong analytical and problem-solving skills, capable of diagnosing process and system gaps, balancing compliance and efficiency, and implementing effective, scalable solutions. Demonstrated success in leading through change in a complex, global environment-able to influence without authority, build consensus, and guide diverse stakeholders through digital and process transformation. Excellent communication and collaboration skills, with experience working across functions, geographies, and cultures, and translating technical topics into clear business language. A track record of promoting digitalization, data quality, and innovative thinking, ideally including AI, automation, and data-driven decision making in quality or GxP contexts. Experience in a large, global pharma or biotech company; background from a top-20 global pharmaceutical organization is a strong plus. Commitment to Takeda's core values, including patient focus, trust, reputation, and business excellence, and a genuine passion for improving how quality is delivered through modern digital systems 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: Lexington, MA U.S. Base Salary Range: $174,500.00 - $274,230.00 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. LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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** Clinical Site Startup & Engagement's vision is to expand Takeda's operational capabilities and drive effective, proactive global clinical-trial planning and management. Through strategic advancements in clinical research and development, CSSE aims to introduce greater efficiencies that make Takeda a preferred partner for sites, fostering a collaborative environment and enabling a more efficient delivery of Takeda's pipeline. CSSE's mission is to work collaboratively, with both internal and external partners, to deliver best-in-class trial execution, identify innovative ideas and employ business process excellence to compliment strategic growth and positively impact cycle time, quality, compliance, and resource utilization. **Role Overview:** The interns will support the current and future fiscal year business efforts for the Clinical Site Startup & Engagement team in the following departments: + Feasibility and Trial Equity + Study Start-Up + Patient Recruitment & Retention Interns will have the opportunity to partner with other business units (Clinical Operations, Regulatory, Legal, Field Medical, R&D Health Equity, etc.) that regularly collaborate in the support of business goals. Interns will develop their knowledge of the R&D process by shadowing CSSE colleagues. This will include attending trial team meetings and strategy sessions, as well as meeting with vendors and our CRO partners. Interns will be expected to present a conclusionary presentation highlighting their experience and sharing learnings. **How You Will Contribute:** Feasibility + Support the identification of the competitive landscape for a given trial/indication Study Start-Up + Review the documents Study Start-Up is responsible for tracking + Support the tracking of reportable metrics Patient Recruitment & Retention + Support the Patient Recruitment and Retention strategy development with a focus on identifying successful methods for effective clinical trial messaging and tactics that will resonate with a broad segment of the population. Trial Equity + Support the development of a global diversity strategy + Support includes but not limited to data aggregation related to the demographics of disease, support trial teams with researching local community-based partnerships and assisting in maintaining the D&I in Clinical Trials resource database (store on SharePoint). + Develop their knowledge of the R&D process by shadowing CSSE colleagues in their support of at least 1 trial. + Collect external communications related to D&I in Clinical Trials to help build their personal acumen. **Internship Development Opportunities:** + The intern(s) will develop strong analytical, problem-solving, and oral/written communication skills through working with other teams, effectively managing projects, and delivering presentations + The intern(s) will develop an analytical approach of compiling data to help drive discussions and decisions + The intern(s) will develop an ability to complete scientific research leveraging both internal & external resources + The intern(s) will develop a basic ability to summarize scientific research and provide high-level reporting + The intern(s) will develop a basic ability to complete data analysis, drawing conclusions/interpreting data **Job Requirements:** + This position will be fully remote + Must be pursuing a bachelor's degree in marketing, natural & physical sciences (biology, chemistry, physics, etc.), biostatistics, mathematics, bioengineering, biomedical engineering, gender studies, ethnic cultural studies, world culture, health education, nursing, medical sciences, pre-pharmaceutical studies or pharmaceutical science + Must have mid-level proficiency with Microsoft applications (Excel, Word, and PowerPoint), compiling statistics, database management, quantitative & qualitative research, basic project planning, research, and basic technical writing **Internship Eligibility** + Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship + Must be currently enrolled in a degree program graduating December 2026 or later + The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) + The intern must be able to commit to one of these time frames + Able to work full time 40 hours a week during internship dates + Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program ** ** **Program Highlights:** + Hands-on experience with real projects and responsibilities + Dedicated mentorship program pairing interns with experienced professionals + Networking opportunities with industry professionals and fellow interns + Internship events focused on professional and skills development + Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd **Takeda Compensation and Benefits** **Summary** We understand compensation may be an important factor as you consider an internship opportunity. 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. Hourly Wage Range:** $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: + Paid sick time + Civic Duty paid time off + Participation at company volunteer events + Participation at company sponsored special events + Access to on-site fitness center (where available) + Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. **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** Paid Intern (Fixed Term) (Trainee) **Time Type** Full time **Job Exempt** No 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. \#LI-Remote

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 Global Development Compliance ensures quality and compliance in Clinical Development in partnership with R&D Quality and GCP Functions. We champion continuous improvement, foster innovation, and maintain an efficient, inspection-ready clinical development model. Embracing technology and automation, we aim to enhance efficiency, streamline processes, and accelerate the delivery of medicines to patients. As GDC Intern, you will have the opportunity to contribute to focused projects for Takeda's R&D and GCP Functions that help drive efficiency, streamline processes, and accelerate the ways we work. Key responsibilities may include: GCP Continuous Improvement Projects: Support overall development of new or revised Good Clinical Practice (GCP) and Clinical Trial Delivery processes and/or training content (may include supporting process map development and refinement, SOPs, RACIs, and developing training content). Support translation of process maps into Takeda systems. Help prepare for, facilitate and support project workshops with key subject matter experts (SMEs). Partner with stakeholders and key SMEs to update and/or create documentation and/or training content. Initiate and facilitate review and feedback for GCP SOPs, process maps, and/or training content. Provide weekly status updates to project teams and manage project plans and action/decision logs. GCP Excellence in Clinical Trials Projects: Contribute to GCP inspection readiness, strategy, and execution activities. Coordinate key activities to enable study team readiness for internal audits and regulatory inspections. Collaborate with the study execution teams on inspection readiness projects. Support real-time regulatory inspections and audits. Contribute to Trial Master File (TMF) health improvement efforts and review key essential trial documentation. Identify and implement improvements in inspection readiness and study execution processes. Pilot innovative technologies and automations for Trial Master File oversight How You Will Contribute: As a Global Development Compliance Intern, you will have the opportunity to… Support and lead aspects of important cross-functional projects at Takeda. Work on deadline-driven activities with an elevated level of organizational and planning skills. Practice strong quantitative, analytical, problem solving and presentation skills. Practice cross functional teamwork and collaboration with key stakeholders. Demonstrate a proven record of accomplishment of teamwork, adaptability, innovation, initiative, and integrity. Internship Development Opportunities: Gain understanding of Good Clinical Practice (GCP) and experience working within a Clinical Trial Delivery environment. Gain experience with conduct of clinical trials (phases 1-4). Gain knowledge of regulatory requirements governing clinical trials and industry best practices. Hone exceptional interpersonal, verbal communication and writing skills. Learn more about Clinical Trial Delivery, Good Clinical Practice and bringing medicine to patients. Learn how to have a global mindset to grow in a diverse work environment. Learn how to collaborate with and work within cross-functional teams. Job Requirements: Adept at utilizing computer software programs (e.g., Microsoft Office and Excel) and project management and collaboration tools (e.g., SharePoint, Teams) to efficiently organize and execute projects. Strong problem-solving abilities and attention to detail. Effective communication skills and ability to influence stakeholder engagement. Ability to work in a fast-paced environment and prioritize tasks. This position will be Fully Remote out of the Cambridge, MA location. Must be pursuing a Bachelor's, Masters, or Doctoral degree in a scientific, business, or relevant discipline. Internship Eligibility Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship Must be currently enrolled in a degree program graduating December 2026 or later The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) The intern must be able to commit to one of these time frames Able to work full time 40 hours a week during internship dates Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: Hands-on experience with real projects and responsibilities Dedicated mentorship program pairing interns with experienced professionals Networking opportunities with industry professionals and fellow interns Internship events focused on professional and skills development Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Florida - Virtual U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: Paid sick time Civic Duty paid time off Participation at company volunteer events Participation at company sponsored special events Access to on-site fitness center (where available) Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. 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. LocationsFlorida - VirtualWorker TypeEmployeeWorker Sub-TypePaid Intern (Fixed Term) (Trainee) Time TypeFull time Job Exempt No

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 DescriptionAbout 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. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities-including small molecules, biologics, and external manufacturing sites-the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes. We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. How you will contribute: Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements. Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes. Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities. Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions. Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics. Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale. Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings. Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact. Promote sustainable practices and scalability in site-level regulatory operations. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. 10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Strong practical experience with global HA requirements, beyond EU/US. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Applies directions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies given prioritization framework with limited support. Excellent written and oral communication skills required. Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork. 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" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 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: $174,500.00 - $274,230.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity Under general direction, facilitates the comprehensive reviews of customer data, determining overall business customers are engaged in. Supports general compliance activities facilitated by the department. How you'll spend your day ESSENTIAL AREAS OF RESPONSIBILITY All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. * Proactively identify emerging risks and report to relevant stakeholders * Carries out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws. * Builds knowledge of the organization, processes, and customers * Identifies the prioritization of risks through reporting measures * Evaluates the adequacy of the company's internal control framework in addressing risks and accomplishing the company's goals and objectives * Conducts comprehensive reviews of customer sales data to ensure suspicious customers are brought to management's attention. * Identifies training needs for risk management and contributes to awareness across the company * Responsible for monitoring new trends and developing proactive strategies and procedures to remain compliant with all State and Federal regulations. * Continually monitors various forms of public and private media for changes in state or federal controlled substance registration landscape. Research current and developing regulations and attends training programs. Promotes early visibility of emerging DEA and state regulatory initiatives that impact the company and develops proactive strategies for complaint solutions. * Monitors suspicious orders reporting system and conducts follow-up activities related to actual incidents. * Assists management during DEA inspections * Performs other related duties as assigned. This position can operate in a hybrid work environment. The selected candidate must be able to work onsite in Weston, FL at least 3 days per week. Your experience and qualifications Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Job requires a daily schedule of 9:00am-6:00PM, periodic weeknights, and periodic Saturday's Education/Certification/Experience: Bachelor's degree from an accredited college or university with (3) years of experience; or equivalent combination of education and related experience. Minimum of 3 years of experience within an administrative, decision-making position. Skills/Knowledge/Abilities: * Advanced skillset in utilizing a variety of application systems (TPS, Cognos, Tableau, Excel, Microsoft Office) * Pharmaceutical experience preferred * Is comfortable working in a decision-making capacity * Can analyze a large dataset into cohesive and actionable recommendations * Demonstrated ability to effectively communicate across different levels of the organization. * Able to communicate in a clear and concise manner, both verbally and in writing, in a variety of communication settings and styles. Can get messages across that have the desired effect. * Uses time effectively and efficiently * Concentrates efforts on the most important priorities * Gets more done in less time than others * Can attend to a broad range of activities and mulit-task * Can effectively cope with change * Can decide and take action without having or needing the total picture * Can comfortably handle risk and uncertainty, is not upset when things are up in the air * Can quickly find common ground and solve problems. * Is seen as a team player and is cooperative. Encourages collaboration * Easily gains trust and support of peers; can be candid with peers. * Has patience to hear people out and can accurately restate the opinions of others when he/she disagrees * Is action-oriented and full of energy for things seen as challenging * Good at figuring out processes necessary to get things done * Knows how to organize people and activities * Learns quickly when facing new problems * Analyzes both successes and failures for clues to improvement * Experiments and will try anything to find solutions * Enjoys the challenge of unfamiliar tasks * Quickly grasps the essence and underlying structure of anything Enjoy a more rewarding choice We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance. Reports To Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Important notice to Employment Agencies - Please Read Carefully Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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 BioLife Plasma Services BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Ltd., is an industry leader in the collection of high-quality plasma that is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can't be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 245+ state-of-the-art plasma donation centers across the United States. Our employees are committed to improving the quality of life for patients and ensuring that the donation process is safe, easy, and rewarding for donors who want to make a difference. When you work at BioLife, you'll feel good knowing what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. This position is currently classified as “hybrid” and is based out of Bannockburn, IL in accordance with Takeda's Hybrid and Remote Work policy. OBJECTIVES/PURPOSE This role focuses on executing the global strategy for BioLife Plasma that aligns with PDT (Plasma Derived Therapies) and Takeda's objectives to drive business results over the mid to long term for a sustainable outcome. Responsibilities include leading the execution of key strategies that impact the growth and innovation of Global BioLife while ensuring cohesive and effective systems & processes exist end-to-end to drive efficiencies across the business. ACCOUNTABILITIES Develop and implement business strategies across functions, processes, or operational plans. Lead cross-functional teams in strategic planning activities, develop milestones and objectives. Communicate with leadership and conduct briefings and meetings with top management and external stakeholders. Prioritize and track strategic business impact across new developments or initiatives. Identify growth opportunities and business model innovations. Evaluate and financially model potential strategic opportunities. Monitor short, medium, and long-term business trends through market intelligence that impact strategy. DIMENSIONS AND ASPECTS Technical/ Functional (Line) Expertise Provide strategic direction to optimize end-to-end global business processes, ensuring alignment with organizational goals. Demonstrate deep expertise in operational planning, systems integration, and financial modeling for growth and efficiency. Decision-making and Autonomy Make high-impact, long-term operational and financial decisions, balancing risks and opportunities aligned with business priorities. Operate with autonomy to lead cross-functional initiatives, ensuring timely delivery and alignment with organizational strategy. Leadership Inspire and lead by fostering a culture of innovation, continuous improvement, and accountability. Act as a strategic partner to senior leadership, delivering insights to shape business outcomes. Interaction Collaborate with global stakeholders across various functions to ensure alignment on strategic initiatives and objectives across the value chain. Serve as a key liaison between executive leadership and operational teams, ensuring effective communication of priorities. Innovation Drive continuous improvement by identifying emerging trends, technologies, and business models to sustain competitive advantage. Champion a culture that encourages innovation and the adoption of transformational strategies. Complexity Navigate challenges within a dynamic global business environment, balancing diverse cultural and regulatory considerations. Manage a mix of established and emerging business units, addressing complexities across geographies and product lifecycles. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS : Education Required: Bachelor's degree in Business Administration, Finance, Healthcare Management, or related field. Preferred: Advanced degree (MBA, MHA, or equivalent) from a recognized institution. Extensive experience (10+ years) in strategic operations, business planning, or leadership in a global setting. Specialized certifications relevant to operational excellence, financial modeling, or healthcare strategy (e.g., PMP, Lean Six Sigma). Skills Strategic Thinking and Execution Strong ability to analyze complex business challenges and translate them into actionable strategies with durable results. Expertise in project management, resource prioritization, and leading cross-functional global teams. Technical Expertise Ability to lead and implement strategic planning exercises across functions and businesses Proficiency in financial modeling, data analytics, and systems integration to optimize operational efficiency. Knowledge of healthcare industry regulations and market dynamics, particularly within plasma-derived therapies or global supply chains. Communication and Influence Exceptional verbal, written, and presentation communication skills; capable of presenting complex information clearly to all stakeholders. Strong influencing skills to gain alignment and drive decision-making among cross-functional teams and executive leadership. Behavioral Competencies Leadership and Collaboration Demonstrates a growth mindset and promotes a culture of inclusion and innovation. Fosters strong partnerships across global teams by building trust and leveraging diverse perspectives. Problem-Solving and Adaptability Resilient in dynamic, fast-paced environments; adapts quickly to changing priorities while maintaining focus on objectives. Applies critical thinking and creativity to overcome barriers and deliver impactful solutions. Accountability and Integrity Operates with a strong sense of ownership, ensuring accountability for results and adherence to ethical standards. Embodies Takeda's values, acting as a role model for transparency and corporate responsibility. BioLife 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: Bannockburn, IL U.S. Base Salary Range: $174,500.00 - $274,230.00 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. LocationsBannockburn, ILUSA - IL - ChicagoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes

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 BioLife Plasma Services BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Limited, is an industry leader in the collection of high-quality plasma, which is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can't be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 250+ state-of-the-art plasma donation centers across the United States. Our employees are dedicated to enhancing the quality of life for patients and ensuring that the donation process is safe, straightforward, and rewarding for donors who wish to make a positive impact. When you work at BioLife, you'll feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. This position is currently classified as “Remote/Virtual” in accordance with Takeda's Hybrid and Remote Work policy. OBJECTIVES/PURPOSE The BioLife Forecasting, Pricing & Analytics (FPA) team within the Plasma-Derived Therapies (PDT) business unit at Takeda is seeking a Senior Pricing Analyst. This role is critical for the FPA team, as it combines technical expertise with strategic insight to inform business financial decisions. You will have the autonomy to own analyses end-to-end, from source data to strategic recommendations, and the opportunity to engage with senior leadership and cross-functional teams, driving data-based decision-making across the organization. It reports to the Associate Director, Pricing, and Business AI Lead at BioLife. ACCOUNTABILITIES Data Analysis & Decision-Making: Leverage strong analytical and quantitative skills to connect raw data across sources, uncover patterns, and deliver insights that directly shape business decisions. Performance Analytics: Assess pricing performance to identify key drivers, risks, and opportunities across centers, fee levels, and donor groups. Statistical Analytics: Contribute to pricing and forecasting projects through advanced data analysis, process automation, A/B testing, and the creation of clear, actionable visualizations. Machine Learning Solutions: Translate complex data challenges into machine learning models (e.g., supervised learning, unsupervised learning, predictive retention, segmentation, elasticity) that enhance business operations and plasma donor insights. Experimentation & Standards: Own the experimentation lifecycle from design to analysis, validating opportunities and scaling winning strategies. Elevate team capabilities by setting best practices in analytics, code quality, and data storytelling. DIMENSIONS AND ASPECTS Technical expertise: Proven hands-on experience with PySpark, Python, SQL, and BI tools (Power BI or Tableau), with advanced Excel skills for rapid analysis. Analytical leadership: Demonstrated ability to proactively identify new opportunities, design models/experiments, and deliver insights that drive measurable business improvements. Agile execution: Thrives in ambiguity and fast-changing environments, with the ability to pivot quickly and still deliver clarity. Clear communication: Ability to distill complex technical findings into clear business narratives. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Required Bachelor's degree in Economics, Statistics, Computer Science, Engineering, Data Science, or a quantitative field required; Master's preferred 5+ years in analytics, pricing, strategy, and/or forecasting with demonstrated impact. Strong foundation in statistics and experimentation - hypothesis testing, regression, causal inference, experimental design, and power calculations. Who You Are A critical thinker who thrives on solving ambiguous problems through rigorous analysis and experimentation. Data-driven, with a passion for uncovering trends, root causes, and actionable insights. Business-minded, able to partner effectively with leadership and product owners to shape strategic decisions. Adaptable and proactive, thriving in a fast-paced, high-visibility environment with competing priorities. ADDITIONAL INFORMATION Domestic travel required (up to 10%). BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - IL - Bannockburn - Virtual U.S. Base Salary Range: $86,500.00 - $135,960.00 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. LocationsUSA - IL - Bannockburn - VirtualMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes

Company: Teva Pharmaceuticals **Who we are** At Teva, we're proud to be a leading innovative biopharmaceutical company, enabled by a world-class generics business. Fueled by our purpose, "we are all in for better health" and desire to be a leader in CNS, we're dedicated to addressing patients' needs, now and in the future. As we strive to improve access and outcomes for patients across all points of care, we're thoughtfully expanding our US sales teams. Sales professionals at Teva are part of a purpose-driven organization with a uniquely diverse portfolio and a promising pipeline focused on core therapeutic areas. We're investing in research, marketing, and innovation - empowering our teams to deliver patient-centric solutions that truly make a difference. If you're ready to join a company that values your contribution and supports your growth, Teva offers the platform to bring better health solutions to patients and providers so we can address the most pressing challenges throughout the treatment journey. **The opportunity** This section is where we attract the attention of potential candidates and sell the role. How has the role come about? What makes it appealing? What are the key responsibilities? How is the role better with Teva than with another company? Wherever possible, we should bring through the essence of our EVP pillars, i.e., we care, we're in it together, and we make work fulfilling. **How you'll spend your day** **ESSENTIAL AREAS OF RESPONSIBILITY** The following areas of responsibility are essential to the satisfactory performance of this position by any incumbent, with reasonable accommodation if necessary. Any nonessential functions are assumed to be included in other related duties or assignments. + Quickly build rapport and personable relationships with HCPs, medical staff, and key decision-makers within accounts and with stakeholders and cross-functional partners within Teva + Provide healthcare product information to physicians, office staff, and key decision-makers within accounts + Work to uncover HCP and staff challenges and develop solutions, provide resources, or connect cross-functional colleagues to meet customer needs + Demonstrate the effort and hustle necessary to meet or exceed customer expectations + Facilitate product and script pull through by working to solve prescriber challenges, interfacing with specialty or facility pharmacies, and connecting cross-functional colleagues to solve problems and provide solutions + Remain apprised of all product formulary developments within facilities + Work with the discharge coordinator to understand patient follow-up treatment and transitions of care + Work to understand the perspectives, challenges, and needs of HCPs, influential stakeholders, and decision-makers within accounts and adapt messaging, tactics, and strategy to influence their prescriber habits + Work to navigate accounts by uncovering and understanding key decision-makers, how different entities work together, different prescribers and their schedules, and the intricacies of different accounts + Take initiative to lead business in an independent manner and take accountability for delivering results and meeting sales goals within their accounts + Engage in pre-call planning to identify goals, consider intricacies of accounts, and create effective plans that are tailored to the unique needs of the account and specific customer + Effectively manage time by understanding available opportunities and challenges, maximizing effectiveness with fewer touchpoints, planning routing to maximize call points within different areas of geography, and adjusting priorities based on changing dynamics + Maintain a hunter mentality and competitive drive with a willingness to go above and beyond role expectations to exceed goals and targets + Develop effective business plans that meet and exceed sales goals by gathering, analyzing, and evaluating relevant market, territory, and competitive data and trends to inform business planning and strategy, and to understand current performance + Work to understand the broader organizational vision, strategy, and values and use them as guideposts for conducting day-to-day activities + Proactively seek opportunities to collaborate and communicate with counterpart sales reps from other sales teams and with individuals both within and outside their immediate team, and maintain a One Teva mindset Proactively share knowledge, ideas, and best practices with cross-functional partners and demonstrate openness to others' ideas **Your experience and qualifications** **POSITION REQUIREMENTS** Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered. Education/Certification/Experience + Bachelor's degree required + Minimum of 5 years of pharmaceutical sales experience required, preferably in the psychiatry or long-acting injectable schizophrenia space + Experience in the hospital setting or long-term care setting with a detailed understanding of the buy-and-bill model, formulary placement, P&T committees, and in-services required + Experience in psychiatric therapeutic areas strongly preferred + Specific experience with long-acting injectables and in-office administration for the treatment of schizophrenia in the hospital setting or long-term care setting preferred + Experience successfully launching products in the psychiatric space across multiple settings of care + Ability to operate within complex settings and networks and provide customer insights effectively Skills/Knowledge/Abilities + Ability to interact with customers in live and virtual environments and proficiency with technology + Understanding of reimbursement coverage and pull-through strategies as well as experience in all pertinent settings of business (CMHC, specialty pharmacy, private practice) + Understanding of the buy-and-bill model + Leadership skills and ability to collaborate with multiple sales teams + Proven written and verbal communication skills + Demonstrated interpersonal skills + Valid US driver's license and acceptable driving record required + Candidate must be able to successfully pass background, motor, and drug screening **TRAVEL REQUIREMENTS** Regular travel, which may include air travel and weekend or overnight travel **Enjoy a more rewarding choice** We offer a competitive benefits package, including: + Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. + Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. + Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays. + Life and Disability Protection: Company paid Life and Disability insurance. + Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. **Already Working @TEVA?** If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (****************************************************************************************** The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. **Teva's Equal Employment Opportunity Commitment** Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. **Important notice to Employment Agencies - Please Read Carefully** Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. EOE including disability/veteran

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 RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. Oversees and provides regulatory operational support for programs in the Therapeutic Area Unit (TAU). Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning. The intern will support the Gastrointestinal (GI) Global Regulatory Project Management & Strategic Planning (RPM&SP) group in advancing regulatory milestones. This role will provide hands-on experience in health authority meeting planning, developing submission timelines, and supporting scenario planning for key regulatory deliverables. How You Will Contribute: The RPM&SP intern will provide valuable support in developing timelines, scenario analyses, and health authority meeting logistics-activities that directly impact the group's ability to meet regulatory milestones efficiently. The intern contribution will help in assisting the lead RPM to focus on strategy while ensuring operational excellence. In addition, the intern's fresh perspective and analytical work will enhance the team's ability to anticipate challenges and optimize submission planning Responsibilities: * Assist in planning and logistics for health authority (HA) meetings, including preparation of timelines, coordination of materials, and tracking key actions. * Support the development of submission timelines and scenario analyses to evaluate regulatory strategy options. * Contribute to the preparation of regulatory documentation and project tracking tools. Internship Development Opportunities: The intern will gain hands-on exposure to the regulatory strategy and operations function within Takeda's GI therapeutic area. By supporting health authority meeting preparation and submission planning, the intern will learn how cross-functional teams collaborate to advance innovative therapies through regulatory milestones. This role provides practical project management and regulatory operations experience that builds a strong foundation for a career in global drug development. Job Requirements: * This position will be Fully Remote * Currently pursuing a Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Pharmacy, or related field. * Strong organizational, analytical, and communication skills. * Interest in regulatory strategy, drug development, and project management. * Proficiency with Microsoft Office (Excel, PowerPoint, Project/Timeline tools a plus). Internship Eligibility * Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship * Must be currently enrolled in a degree program graduating December 2026 or later * The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) * The intern must be able to commit to one of these time frames * Able to work full time 40 hours a week during internship dates * Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: * Hands-on experience with real projects and responsibilities * Dedicated mentorship program pairing interns with experienced professionals * Networking opportunities with industry professionals and fellow interns * Internship events focused on professional and skills development * Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. 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. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: * Paid sick time * Civic Duty paid time off * Participation at company volunteer events * Participation at company sponsored special events * Access to on-site fitness center (where available) * Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. 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 Paid Intern (Fixed Term) (Trainee) Time Type Full time Job Exempt No 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.

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 DescriptionAbout the role: This is an exciting time for the Plasma Derived Therapies business unit, Immune Deficiency and Neuromuscular franchise! Join our launch team as Associate Director, HCP Marketing, where you will be a key leader responsible for helping develop the strategic direction of our newest addition to the IG portfolio as we prepare for a best-in-class launch in PI. This role is highly visible and important, as its remit will span all HCP marketing stakeholders and channels. Working closely with our customer engagement colleagues, you will develop and execute tactics likely including but not limited to personal and non-personal promotion, search, professional engagements, and congress presence. Success in the role will depend on effective cross-functional partnership and collaboration. You will also leverage data and insights to inform the decision-making processes and ensure that our strategies are rooted in deep understanding of HCPs' needs and behaviors. You will accomplish all of this through a focus on the end goal of winning for patients. You will report to the Director, USBU PDT Launch Lead. How you will contribute: Partner with the Launch Lead in developing: - Positioning: brand personality, differentiation, brand pillars - Campaign: core creative platform, research to inform concept selection Be the daily lead in the implementation of all HCP pull-through marketing, partnering with multiple internal stakeholders and external agencies. Partner with SCIG brand team to ensure clarity in brand differentiation. Partner with Insights & Analytics to sharpen portfolio strategy with this new brand entrant. Distill insights, validate business opportunities, optimize channel mix, and educate HCPs. Own strategically aligned engagement plans and tactics ensuring successful execution. Collaborate with brand and franchise teams to launch: - HCP and Access marketing resources - HCP fee-for-service plan and pull through (advisory boards, speaker pro grams, consulting) - P2P strategy and resource development - National and regional congress plans, including exhibit design/strategy, symposia/product theater content, KOL engagements - Regional marketing resources as appropriate Recognize industry/competitive trends to identify brand growth opportunities and identify industry and internal best practices to build organizational capability Manage multiple agencies from strategic brief ideation through to delivery, holding them accountable to Takeda USBU policies, standards, timelines and budgets Oversee the direction and deliverables of multiple priorities ensuring internal stakeholder alignment, across agency partners, and cross functional partners including PRT, medical affairs, compliance, and IT Minimum Requirements/Qualifications: Bachelor's degree 8+ years' experience with increasing responsibilities in sales, marketing or related function 4+ years of dedicated experience engaging with HCPs Foster collaboration, and enable teamwork Set priorities, develop roles and responsibilities, and manage external partners Deep understanding of a brand/franchise strategy and how to effectively engage HCPs; have a strong understanding of business, finance and risks/benefits of decisions Experience in marketing strategy and tactic design with an ability to communicate ideas to internal colleagues and external partners Broad-based HCP Marketing knowledge from non-personal (e.g., designing/running a CRM program) to field sales (e.g., managing deployment of assets) Leverage data and analytics to distill insights and drive data-based decision making Preferred: MBA Pharmaceutical industry experience Experience working on a product launch Experience in PDT, particularly Primary Immunodeficiency Experience developing engagement plans for thought leaders / key opinion leader management and ability to comfortably liaise with these customers Travel: Requires approximately 25-40% travel, which includes travel to Cambridge, MA office Ability to travel to various internal and external meetings and conferences that could include overnight stays ranging from one to several nights. Some weekend travel may be required. 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: USA - MA - Cambridge - Kendall Square - 500 U.S. Base Salary Range: $153,600.00 - $241,340.00 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. LocationsUSA - MA - Cambridge - Kendall Square - 500Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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 Clinical Site Startup & Engagement's vision is to expand Takeda's operational capabilities and drive effective, proactive global clinical-trial planning and management. Through strategic advancements in clinical research and development, CSSE aims to introduce greater efficiencies that make Takeda a preferred partner for sites, fostering a collaborative environment and enabling a more efficient delivery of Takeda's pipeline. CSSE's mission is to work collaboratively, with both internal and external partners, to deliver best-in-class trial execution, identify innovative ideas and employ business process excellence to compliment strategic growth and positively impact cycle time, quality, compliance, and resource utilization. Role Overview: The interns will support the current and future fiscal year business efforts for the Clinical Site Startup & Engagement team in the following departments: Feasibility and Trial Equity Study Start-Up Patient Recruitment & Retention Interns will have the opportunity to partner with other business units (Clinical Operations, Regulatory, Legal, Field Medical, R&D Health Equity, etc.) that regularly collaborate in the support of business goals. Interns will develop their knowledge of the R&D process by shadowing CSSE colleagues. This will include attending trial team meetings and strategy sessions, as well as meeting with vendors and our CRO partners. Interns will be expected to present a conclusionary presentation highlighting their experience and sharing learnings. How You Will Contribute: Feasibility Support the identification of the competitive landscape for a given trial/indication Study Start-Up Review the documents Study Start-Up is responsible for tracking Support the tracking of reportable metrics Patient Recruitment & Retention Support the Patient Recruitment and Retention strategy development with a focus on identifying successful methods for effective clinical trial messaging and tactics that will resonate with a broad segment of the population. Trial Equity Support the development of a global diversity strategy Support includes but not limited to data aggregation related to the demographics of disease, support trial teams with researching local community-based partnerships and assisting in maintaining the D&I in Clinical Trials resource database (store on SharePoint). Develop their knowledge of the R&D process by shadowing CSSE colleagues in their support of at least 1 trial. Collect external communications related to D&I in Clinical Trials to help build their personal acumen. Internship Development Opportunities: The intern(s) will develop strong analytical, problem-solving, and oral/written communication skills through working with other teams, effectively managing projects, and delivering presentations The intern(s) will develop an analytical approach of compiling data to help drive discussions and decisions The intern(s) will develop an ability to complete scientific research leveraging both internal & external resources The intern(s) will develop a basic ability to summarize scientific research and provide high-level reporting The intern(s) will develop a basic ability to complete data analysis, drawing conclusions/interpreting data Job Requirements: This position will be fully remote Must be pursuing a bachelor's degree in marketing, natural & physical sciences (biology, chemistry, physics, etc.), biostatistics, mathematics, bioengineering, biomedical engineering, gender studies, ethnic cultural studies, world culture, health education, nursing, medical sciences, pre-pharmaceutical studies or pharmaceutical science Must have mid-level proficiency with Microsoft applications (Excel, Word, and PowerPoint), compiling statistics, database management, quantitative & qualitative research, basic project planning, research, and basic technical writing Internship Eligibility Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship Must be currently enrolled in a degree program graduating December 2026 or later The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) The intern must be able to commit to one of these time frames Able to work full time 40 hours a week during internship dates Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: Hands-on experience with real projects and responsibilities Dedicated mentorship program pairing interns with experienced professionals Networking opportunities with industry professionals and fellow interns Internship events focused on professional and skills development Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. 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. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: Paid sick time Civic Duty paid time off Participation at company volunteer events Participation at company sponsored special events Access to on-site fitness center (where available) Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. 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. LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypePaid Intern (Fixed Term) (Trainee) Time TypeFull time Job Exempt NoIt 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.

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 DescriptionAbout 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 Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of assigned product(s) in various stages of drug development, which may include products of medium complexity and updates to TLP, CCDS, USPI and EU SmPC. You will also be responsible for providing support to the development and implementation of labeling content and strategy of high complexity product(s). How you will contribute: With appropriate supervision and guidance: Management of Labeling Cross-Functional Teams Leads Labeling cross-functional teams, facilitates discussions on labeling strategies and content for assigned product(s) and ensures cross-functional collaboration and alignment, for assigned product(s), with appropriate supervision and guidance. Assists in the development of labeling strategies and content and to ensuring cross-functional alignment for other medium and/or high complexity products. Interface with Senior Management Cross-Functional Team (GLOC) Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) and facilitates discussions to ensure cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels, with appropriate supervision, guidance and alignment with TAU/MPD Labeling Lead. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Authors 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 appropriate 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. Authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance. Employs project management skills to interface with global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and participates in label negotiations with Health Authorities. Ensures labeling content conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages the 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. Proactively strengthen and foster robust relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure highly effective communication of labeling strategy and content. Precedent Search and Labeling Trends Conducts precedent searches, 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 (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. Participates in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products. Support in Managing Labeling Deliverables for Medium and/or High Complexity Products Assist in managing high complexity products by working with GLLs and labeling management on assigned labeling tasks such as review and edit labeling documents, assist in leading LWG meetings, coordinate labeling local update / exception process etc. 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. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 6+ years of pharmaceutical industry experience. This is inclusive of 4 years of labeling experience or combination of 4+ years regulatory and/or related experience. Knowledge of US and EU product labeling regulatory requirements and guidelines. Familiarity with US and/or EU regulatory requirements and guidelines. Familiarity with other relevant regional regulatory nuances and requirements. Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development. Ability to co-author, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions with appropriate supervision and guidance. Ability to identify factors and requirements necessary for regulatory recommendations. Ability to develop regulatory strategies based on regulatory requirements and competitive landscape. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy. 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: $137,000.00 - $215,270.00 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. LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

Company: Teva Pharmaceuticals **Who we are** Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. **The opportunity** Under general direction, facilitates the comprehensive reviews of customer data, determining overall business customers are engaged in. Supports general compliance activities facilitated by the department. **How you'll spend your day** **ESSENTIAL AREAS OF RESPONSIBILITY** All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. + Proactively identify emerging risks and report to relevant stakeholders + Carries out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws. + Builds knowledge of the organization, processes, and customers + Identifies the prioritization of risks through reporting measures + Evaluates the adequacy of the company's internal control framework in addressing risks and accomplishing the company's goals and objectives + Conducts comprehensive reviews of customer sales data to ensure suspicious customers are brought to management's attention. + Identifies training needs for risk management and contributes to awareness across the company + Responsible for monitoring new trends and developing proactive strategies and procedures to remain compliant with all State and Federal regulations. + Continually monitors various forms of public and private media for changes in state or federal controlled substance registration landscape. Research current and developing regulations and attends training programs. Promotes early visibility of emerging DEA and state regulatory initiatives that impact the company and develops proactive strategies for complaint solutions. + Monitors suspicious orders reporting system and conducts follow-up activities related to actual incidents. + Assists management during DEA inspections + Performs other related duties as assigned. **This position can operate in a hybrid work environment. The selected candidate must be able to work onsite in Weston, FL at least 3 days per week.** **Your experience and qualifications** Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. **Job requires a daily schedule of 9:00am-6:00PM, periodic weeknights, and periodic Saturday's** **Education/Certification/Experience:** Bachelor's degree from an accredited college or university with (3) years of experience; or equivalent combination of education and related experience. Minimum of 3 years of experience within an administrative, decision-making position. **Skills/Knowledge/Abilities:** + Advanced skillset in utilizing a variety of application systems (TPS, Cognos, Tableau, Excel, Microsoft Office) + Pharmaceutical experience preferred + Is comfortable working in a decision-making capacity + Can analyze a large dataset into cohesive and actionable recommendations + Demonstrated ability to effectively communicate across different levels of the organization. + Able to communicate in a clear and concise manner, both verbally and in writing, in a variety of communication settings and styles. Can get messages across that have the desired effect. + Uses time effectively and efficiently + Concentrates efforts on the most important priorities + Gets more done in less time than others + Can attend to a broad range of activities and mulit-task + Can effectively cope with change + Can decide and take action without having or needing the total picture + Can comfortably handle risk and uncertainty, is not upset when things are up in the air + Can quickly find common ground and solve problems. + Is seen as a team player and is cooperative. Encourages collaboration + Easily gains trust and support of peers; can be candid with peers. + Has patience to hear people out and can accurately restate the opinions of others when he/she disagrees + Is action-oriented and full of energy for things seen as challenging + Good at figuring out processes necessary to get things done + Knows how to organize people and activities + Learns quickly when facing new problems + Analyzes both successes and failures for clues to improvement + Experiments and will try anything to find solutions + Enjoys the challenge of unfamiliar tasks + Quickly grasps the essence and underlying structure of anything **Enjoy a more rewarding choice** We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance. **Reports To** **Already Working @TEVA?** If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (****************************************************************************************** The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. **Teva's Equal Employment Opportunity Commitment** Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. **Important notice to Employment Agencies - Please Read Carefully** Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. EOE including disability/veteran

Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The Director, in Global Regulatory Medical Writing, may write and edit clinical regulatory documents, including submission summaries and other complex documents, provides a significant level of oversight and expert guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations. The Director offers clear leadership and extensive accountability, strategic vision, and planning for clinical regulatory documents. Travel Requirements: International and domestic Location: US-Based Remote (US Eastern time zone preferred) How you'll spend your day All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. * Primarily works on the therapeutic area/functional level * Likely to have direct reports; oversees contingent workers and/or vendors; provides training to others; strategically analyzes needs to manage resources and is accountable for resource allocation * Oversees/mentors for all document types * May write and edit clinical regulatory documents (all types) * Ensures that documents include the proper context and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards * Leads/recommends the preparation/revision of document templates * Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans * Responsible for tracking/providing metrics and established key performance indicators Your experience and qualifications * PhD/PharmD with a minimum 8 years experience or a Master's with a mnimum of 10 years experience * Mastery of Microsoft Word * Advanced regulatory medical writing expertise, strong writing/editing skills, knowledge of drug development regulations * Global regulations and guidelines for document submissions Compensation Data The annual starting salary for this position is between $177,680 - $233,205 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate. Enjoy a more rewarding choice We offer a competitive benefits package, including: Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays. Life and Disability Protection: Company paid Life and Disability insurance. Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Important notice to Employment Agencies - Please Read Carefully Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.