Logistics

Bilingual Loan Consultant

At OneMain, Loan Sales Specialists empower customers by listening to their needs and providing access to friendly, fast, and affordable financing for life’s expenses. In this role, our team members thrive in a competitive atmosphere where hard work and dedication directly influence success. This role provides rewarding professional development and advancement opportunities in a dynamic and supportive environment. Loan Sales Specialists enjoy competitive compensation that recognizes both individual achievements and team success, all while growing their career. In the Role Effectively multitask and adapt to the dynamic demands of the role, ensuring timely and efficient service Exceed customer expectations through ease, empathy and encouragement, delivering results related to individual and branch goals Develop new connections and maintain ones by engaging customers throughout the loan process and life cycle, presenting tailored solutions based on customer needs Manage the life cycle of loans, including collections activities while maintaining compliance with all relevant laws and regulations Engage with customers and other departments through multiple technological channels, including phone, email, chat and our in-house systems Exhibit passion for achievement, bringing an internal drive to succeed and goal oriented attitude Clearly educate and inform customers on optional insurance products, ensuring customers have a thorough understanding of the loans, terms and their options Requirements: High School Diploma or GED Preferred: Sales, Collections or Customer Service experience Bilingual - Spanish Location: On site The schedule for this position is Monday-Friday during standard business hours, with some extended hours during the week as needed which may include Saturday. Who we Are A career with OneMain offers you the potential to earn an annual salary plus incentives. You can steer your career toward leadership roles such as Branch Manager and District Manager by taking advantage of a variety of robust training programs and opportunities to advance. Other team member benefits include: Health and wellbeing options including medical, prescription, dental, vision, hearing, accident, hospital indemnity, and life insurances Up to 4% matching 401(k) Employee Stock Purchase Plan (10% share discount) Tuition reimbursement Paid time off (15 days’ vacation per year, prorated based on start date) Paid sick leave as determined by state or local ordinance (prorated based on start date) 11 Paid holidays (4 floating holidays, prorated based on start date) Paid volunteer time (3 days per year, prorated based on start date) OneMain Financial (NYSE: OMF) is the leader in offering nonprime customers responsible access to credit and is dedicated to improving the financial well-being of hardworking Americans. Since 1912, we’ve looked beyond credit scores to help people get the money they need today and reach their goals for tomorrow. Our growing suite of personal loans, credit cards and other products help people borrow better and work toward a brighter future. In our more than 1,300 community branches and across the U.S., team members help millions of customers solve critical financial needs, including debt consolidation, home and auto repairs, medical procedures and extending household budgets. We meet customers where they want to be in person, by phone and online. At every level, we’re committed to an inclusive culture, career development and impacting the communities where we live and work. Getting people to a better place has made us a better company for over a century. There’s never been a better time to shine with OneMain. Key Word Tags Sales, Collections, Retail, Loan Sales, Customer Service, Customer Care, Business Development, New Grad, Newly Graduated, Entry level, Financial Sales, Management Development, Management Trainee, Finance, Full-time, Career, Benefits, Customer experience, Financial Representative, Credit, Leadership, Manager Trainee

  • Haverhill, FL

  • no content

Recreation Attendant

Are you looking for a place where meaningful moments are made together? At Hyatt Vacation Club (HVC), we make vacation dreams come true for travelers around the world in a supportive, friendly, and beautiful work environment. As a Recreation Attendant at HVC, you will assist in providing our Owners/guests with experiences and events to make memorable vacation memories, everyone is connected by care and inclusivity. Where great benefits lead to a life fulfilled. Competitive Pay Medical/Dental/Vision/401K opportunities Travel discounts Credit Union Membership Tuition Reimbursement Professional Counseling & Family Support Growth and Development Opportunities *Benefit Eligibility will vary by position Shift: 1st/2nd; must be available to work weekends and holidays Site Specific Perks Free On-Site Parking Free Golf Discounted meals Department celebrations Associate Appreciation Week Monthly associate recognition and reward programs Monthly phone stipend As a Recreation Attendant, a typical day will include: Promotes a fun and relaxing atmosphere for Owner/guests in all recreational activities and areas. Expresses an upbeat and enthusiastic attitude. Provides information to Owner/guests about available recreational facilities, activities, lessons, and equipment. Encourages and recruits’ Owner/guests to participate in recreation activities. Registers and schedules Owners/guests for activities by recording information using the appropriate methods. Processes payments for rental equipment, recreation activities, facility rentals, or retail sales. Guest Experience and Company Standards Welcome and greet guests and anticipate and address their needs. Interact with colleagues and guests professionally and promptly. Contribute to team goals. Always follow company policies and safety procedures. To Become a Recreation Attendant at HVC: Available to work various shifts, holidays, and both weekend days. Reach overhead and below the knees, perform bending, twisting, pulling, and stooping, and be able to stand, sit, or walk for an extended period of time. Lift/Carry/Push/Pull Items that Weigh up to 25lbs without assistance. Position may require background and drug screening contingent on company policy in accordance with applicable legal requirements. Hyatt Vacation Ownership is an equal opportunity employer committed to hiring a diverse workforce and sustaining an inclusive culture.

  • Cathedral City, CA

  • no content

Sr Workday Integration Analyst

Job Summary Job Description Position Summary We are seeking a highly skilled and experienced Senior Workday Integration Analyst to join our HR Technology team. This role is responsible for designing, developing, testing, and maintaining Workday integrations that support HR business processes. The ideal candidate will have deep expertise in Workday Studio, EIBs, Core Connectors, and other integration tools, along with strong analytical and communication skills. Key Responsibilities Lead the design and development of complex Workday integrations using Workday Studio, EIB, Core Connectors, and Web Services (SOAP/REST). Collaborate with HR, Payroll, Finance, Benefits, IT teams etc. to gather requirements and deliver scalable integration solutions. Monitor and maintain existing integrations, troubleshoot issues, and implement enhancements. Ensure data integrity and security across all integrations. Manage integration lifecycle including documentation, testing, deployment, and support. Stay current with Workday releases and recommend improvements or new features. Provide mentorship and guidance to junior analysts and developers. Required Qualifications Bachelor’s degree in Computer Science, Information Systems, or related field. 6 years of experience in Workday integrations, including hands-on experience with Workday Studio. Strong understanding of XML, XSLT, XPath, and web service technologies (SOAP, REST). Experience with Workday Core Connectors, EIBs, and Workday Web Services. Proficiency in data mapping, transformation, and troubleshooting integration errors. Experience with DIS-based integration system. Integration/Reporting domain experience in HR, Payroll, Benefits, Talent, Learning and Compensation. Experience with Integration using Cloud Connect to take advantage of Workday Web Services. Proficiency in creating and editing Business Process, Custom Reports and Dashboards. Ability to create BIRT reports, Report Groups, and Composite Reports. Understanding of integration security including authentication, authorization, and encryption. Experience implementing secure data transfer protocols and managing access controls. Excellent problem-solving, communication, and project management skills. Ability to manage multiple priorities and meet deadlines in a fast-paced environment. Strong attention to detail and commitment to delivering high-quality work. Excellent verbal and written communication skills. Effective presentation skills for conveying technical concepts to non-technical audiences. Required Workday Certifications Workday Integration Core Workday Studio Preferred Workday Certifications Workday Cloud Connect for HCM and Payroll Workday Reporting and Prism Analytics (a plus) Preferred Skills Experience with UKG Dimensions integrations and configuration. Familiarity with UKG Dimensions APIs, data structures, and configuration. Understanding of timekeeping, scheduling, and workforce management processes. Hands-on experience designing and deploying integrations using Dell Boomi AtomSphere. Ability to build and manage Boomi processes, connectors, and data mappings. Experience with Boomi error handling, logging, and performance optimization. Knowledge of Boomi’s role in middleware architecture and integration orchestration. Experience with Workday Extend or Workday Orchestrate. Familiarity with Agile methodologies and tools like JIRA or ServiceNow. Knowledge of security protocols and data privacy regulations (e.g., GDPR, HIPAA). Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $101,000.00 - $152,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here . For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here . Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

  • Auburn, IL

  • no content

Operations Manager

About Bering Straits Professional Services Bering Straits Professional Services (BSPS) is committed to world-class management of global logistics, training and procurement services for U.S. Government agencies. BSPS is certified by the . In February 2022, BSPS became an International Organization for Standardization (ISO) 9001 certified company. BSPS received the ISO 9001 quality standard certification through the Performance Review Institute (PRI). About this position: Operations Manager in Lexington, KY The Essential Duties and Responsibilities are intended to present a descriptive list of the range of duties performed for this position and are not intended to reflect all duties performed within the job. Other duties may be assigned. To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the position. Applicants will be notified via email or phone within ten business days regarding application status. Essential Duties & Responsibilities • Responsible for the Operation of a Support Center providing support for over 100 teams located across the United States • Ensure daily operations are being performed within the scope of the contract • Forecast requirements and needed surges in personnel and resources • Supervise section leaders within the operations branch • Identifies trends and assesses opportunities to improve processes • Presents in process review briefings and other reports to the Government as required • Performs duties as the backup for the site director when needed Required (Minimum Necessary) Qualifications • Education Requirements: Bachelor’s Degree or equivalent experience • Level of Experience Requirements: 5 years of management and supervisory experience • Must obtain and maintain a secret security clearance Knowledge, Skills, Abilities, and Other Characteristics • Knowledge of organizational procedures and workflows – understanding how work moves through a company. • Basic knowledge of relevant technologies or tools – e.g., Microsoft 365, communication platforms, or industry‑standard software. • Knowledge of customer service practices – principles of providing quality service and managing inquiries professionally. • Knowledge of data privacy and confidentiality principles – awareness of proper handling of sensitive information. • Communication skills (written and verbal) – ability to convey information clearly and professionally. • Time management and prioritization – balancing multiple tasks and meeting deadlines. • Problem‑solving and critical thinking – analyzing issues and selecting appropriate solutions. • Interpersonal and teamwork skills – building rapport and collaborating effectively with others. • Attention to detail – producing accurate, error‑free work. Preferred • Management experience on a government contract • Experience with Maximo inventory system • Experience with performance-based logistics measures Necessary Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this role. Employees must always maintain a constant state of mental alertness. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Essential and marginal functions may require maintaining physical condition necessary for bending, stooping, sitting, walking or standing for prolonged periods of time; most of time is spent sitting in a comfortable position with frequent opportunity to move about. Work Environment The work environmental characteristics described here are representative of those that must be borne by an employee to successfully perform the essential functions of the role. Employees must always maintain a constant state of situational awareness. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Job is performed in an office setting with exposure to computer screens and requires extensive use of a computer, keyboard, mouse and multi-line telephone system. The work described herein is primarily a modern office setting. Occasional travel may be required. Supervisory Responsibilities • This position will have supervisory responsibilities. DOT Covered/Safety-Sensitive Role Requirements • This position is not subject to federal requirements regarding Department of Transportation “safety-sensitive” functions. Additional Qualifying Factors As a condition of employment, you will be required to pass a pre-employment drug screening and have acceptable background check results. If applicable to the contract, you must also obtain and maintain the appropriate clearance levels required and must also be able to obtain access to military installations. Shareholder Preference BSNC gives hiring, promotion, training, and retention preference to BSNC shareholders, shareholder descendants and shareholder spouses who meet the minimum qualifications for the job. Bering Straits Native Corporation is an equal opportunity employer. All applicants will receive consideration for employment without regard to any status protected by state or federal law, or any other basis prohibited by law.

  • Lexington, KY

  • no content

SHIFT SUPERVISOR

Shift Supervisor Restaurant - Food Service Supervisor - Management If you are a positive, energetic person looking for a career that offers an excellent compensation package and the chance for advancement, Braum's is the place for you! Position: Shift Supervisor Minimum Experience: 1 year Shift: 5:30 am - 3:00 pm Hourly Compensation: $14.50 - $15.00 (annually $35,500 - $37,000) Shift Supervisor's role: Braum's leaders execute the company's brand strategy and promote its vision, mission and values, resulting in a great customer experience and maximized sales. By recognizing the importance of our people, we can strengthen the team's contribution toward unit goals being achieved. •Teach, coach and provide leadership to the store crew members. •Maximize store sales through customer satisfaction and food quality. •Oversee the shift operations of Braum's food service function, grocery market and fountain sales. •Actively participate in monitoring inventory and supply levels, kitchen equipment, safety and cleanliness as needed. •Share in responsibility for ensuring that Braum's store policies and practices are implemented and followed accordingly. Work Schedule: Work days vary based on a rotating 3 week schedule with an expected 45 hour work week. Reports to: Assistant Manager If your work experience demonstrates the following traits/abilities we would like to hear from you. •Customer focus. •Work ethic with high standard for integrity. •Positive approach to training, developing and interacting with all team members. •Ability to build a successful team by building an environment of trust. •Ability to adapt to customer and employee needs as well as store environment conditions. •Can communicate effectively with leadership team members. •Follow-up and follow through discipline. •Initiate action and achieve goals. •Organized, detailed and able to follow practices/procedures. •Retail experience. •High School Diploma or G.E.D. •Must be at least 21 years old Benefits: •Medical insurance •Dental insurance •Vision insurance •401k retirement planning with company match •Short-Term Disability insurance •Paid vacations •Product discounts and MORE! Braum's is an equal opportunity employer A criminal background check and a job-fit assessment are required as part of the on-boarding process. 2026-0418

  • Euless, TX

  • no content

Director, Regulatory Site CMC (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. 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: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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.

  • Cambridgeport, MA

  • no content

Director, Regulatory Site CMC - Leading Innovation in Pharmaceutical R&D (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. 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: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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.

  • Cambridgeport, MA

  • no content

Director, Clinical Operations, Oncology - Remote Work Flexibility (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Operations, Oncology based remotely reporting to the Executive Director, Clinical Operations, Oncology. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU). Responsible for line management and provides expert counsel for issue resolution, including programs assigned to other staff, when required. Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations: Accountable for the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines. Accountable for the oversight of Strategic Partners and other vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. The assigned clinical program(s) will be large, complex, high risk and/or of business importance to Takeda or potentially a suite of programs, requiring multi-functional leadership experience and skills to achieve program goals. If a single program is assigned, the program will typically be significant in scope (e.g., multiple independent indications with individual Clinical Sub Teams (CSTs)). A CCOUNTABILITIES: Oversee COPLs assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or CST, working closely with GPT Leadership to ensure program objectives are met. Represent Clinical Operations for assigned program(s) in issue escalation/awareness with senior management, e.g. functional or regional executive staff, PRC, alliance governance committees. Contribute to the Clinical Development Plan(s) and associated operational strategy, in support of the Asset Strategy. Accountable for program budget planning and external spend related to program execution and works closely with Global Program Management, and Finance to ensure financial accuracy. Ensures communication of program status, cost and issues to inform timely decision-making by senior management. Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees; accountable for operational risk management strategy in collaboration with Strategic Partners. Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs in support of inspection activities Collaborates with and is responsible to the Senior Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program(s). Demonstrate advanced Takeda Leadership Behaviors and act as a role model for Takeda´s values. Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives. May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence. ​ EDUCATION AND EXPERIENCE: Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable. 12 or more years’ experience in pharmaceutical industry, including 9 or more years in clinical study management. Experience must include early phase experience or Phase 2 and 3 studies and global/international programs. Oncology experience is required. Experience in more than one therapeutic area and in line management is advantageous. Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals. Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Supervisory experience. Demonstrated excellence in project/program management and matrix leadership. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). Able to influence without authority. Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo. Pragmatic and willing to drive and support change. Is comfortable with ambiguity. Support a culture of continual improvement and innovation; promote knowledge sharing. 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: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. LI-Remote

  • Boston, MA

  • no content

Head of Regulatory Compliance and Site Management (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. 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: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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.

  • Cambridgeport, MA

  • no content

Head of Oncology Clinical Trials Management (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Operations, Oncology based remotely reporting to the Executive Director, Clinical Operations, Oncology. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU). Responsible for line management and provides expert counsel for issue resolution, including programs assigned to other staff, when required. Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations: Accountable for the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines. Accountable for the oversight of Strategic Partners and other vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. The assigned clinical program(s) will be large, complex, high risk and/or of business importance to Takeda or potentially a suite of programs, requiring multi-functional leadership experience and skills to achieve program goals. If a single program is assigned, the program will typically be significant in scope (e.g., multiple independent indications with individual Clinical Sub Teams (CSTs)). A CCOUNTABILITIES: Oversee COPLs assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or CST, working closely with GPT Leadership to ensure program objectives are met. Represent Clinical Operations for assigned program(s) in issue escalation/awareness with senior management, e.g. functional or regional executive staff, PRC, alliance governance committees. Contribute to the Clinical Development Plan(s) and associated operational strategy, in support of the Asset Strategy. Accountable for program budget planning and external spend related to program execution and works closely with Global Program Management, and Finance to ensure financial accuracy. Ensures communication of program status, cost and issues to inform timely decision-making by senior management. Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees; accountable for operational risk management strategy in collaboration with Strategic Partners. Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs in support of inspection activities Collaborates with and is responsible to the Senior Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program(s). Demonstrate advanced Takeda Leadership Behaviors and act as a role model for Takeda´s values. Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives. May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence. ​ EDUCATION AND EXPERIENCE: Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable. 12 or more years’ experience in pharmaceutical industry, including 9 or more years in clinical study management. Experience must include early phase experience or Phase 2 and 3 studies and global/international programs. Oncology experience is required. Experience in more than one therapeutic area and in line management is advantageous. Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals. Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Supervisory experience. Demonstrated excellence in project/program management and matrix leadership. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). Able to influence without authority. Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo. Pragmatic and willing to drive and support change. Is comfortable with ambiguity. Support a culture of continual improvement and innovation; promote knowledge sharing. 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: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. LI-Remote

  • Boston, MA

  • no content

Senior CMC Regulatory Affairs Manager (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. 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: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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.

  • Cambridgeport, MA

  • no content

Director, Global Regulatory Lead - Oncology - Shape global regulatory strategies for groundbreaking cancer treatments (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Director, Global Regulatory Lead Oncology you will set global regulatory strategy and lead major submissions for high-impact oncology programs. How you will contribute: Oversee as well as execute all regulatory activities of one or multiple complex projects in development and/or supports regulatory activities for assigned projects. Serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility. May lead the global regulatory sub-team (GRT) for assigned projects. May serve as global and/or regional regulatory lead as a member of a GRT Primary FDA contact for projects of responsibility. Accountable for all US FDA submissions and approvals of project(s) of responsibility. Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA) For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Participate with influence in or leads departmental and cross-functional task-forces and initiatives. May partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Develop/author and execute global regulatory strategies for complex strategies. May oversee execution. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. May lead regulatory assessment as part of due diligence teams for licensing opportunities. Identify and propose solutions to management for any resource gaps for assigned project(s). May present to senior management as requested. Participate with influence in or leads departmental and cross-functional task-forces and initiatives. Minimum Requirements/Qualifications: Bachelor’s Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred. A minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus. Experience in managing major regulatory filing(s); and experience as a significant contributor to regulatory and/or development strategies Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrate strong skills with increasing independence in the area of regulatory strategy. Strong ability to work well with others and within global teams; and acceptable at communicating with senior leadership. Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. 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: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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.

  • Cambridgeport, MA

  • no content