Food

Store Cleaning Associate

HomeGoodsAt TJX Companies, every day brings new opportunities for growth, exploration, and achievement. You’ll be part of our vibrant team that embraces diversity, fosters collaboration, and prioritizes your development. Whether you’re working in our four global Home Offices, Distribution Centers or Retail Stores—TJ Maxx, Marshalls, Homegoods, Homesense, Sierra, Winners, and TK Maxx, you’ll find abundant opportunities to learn, thrive, and make an impact. Come join our TJX family—a Fortune 100 company and the world’s leading off-price retailer. Job Description: Opportunity: Grow Your Career Responsible for maintaining a clean and organized store environment with a focus on floor care. Responsibilities include the operation of the scrubber and buffer, dust mopping, damp mopping, sweeping, vacuuming, dusting, and spot cleaning glass and windows. Adheres to all operational, merchandise, and loss prevention standards. Cross-trained to work in multiple areas of the store in order to support the needs of the business. Role models established customer experience practices with internal and external customers Supports and embodies a positive store culture through honesty, integrity, and respect Maintains all floor care cleanliness standards including the maintenance and operation of the scrubber and buffer Maintains all organizational, cleanliness, and recovery standards for the entire store, e.g. Sales Floor, Single Queue, Associate Lounge, Backroom and Restrooms Adheres to all company policies concerning Health and Safety (includes the refilling of all essential items in the Lounge, Restrooms and Front End) Cross-trained in other areas of the store (Backroom, Front End, Sales Floor, etc.) Supports and responds to all Front End coverage needs Adheres and upholds merchandising philosophy and signage standards Initiates and participates in store recovery as needed throughout the day Adheres to all operational and loss prevention controls in accordance with company guidelines and policies including shrink reduction Communicates accurately and effectively with management and Associates Adheres to all labor laws, policies, and procedures, including Associate meal and break period policies Participates in safety awareness maintains a safe environment Other duties as assigned Who We're Looking For: You. Excellent customer service skills Able to work a flexible schedule to support business needs Strong organizational skills with attention to detail Physical stamina to perform cleaning tasks and run floor buffer and scrubber Capable of multi-tasking Able to respond appropriately to changes in direction or unexpected situations Strong communication skills: verbal and written. Listens and responds appropriately Capable of lifting heavy objects with or without reasonable accommodation Standout colleague, working effectively with peers and supervisors Retail customer experience preferred Benefits include: Associate discount; EAP; smoking cessation; bereavement; 401(k) Associate contributions; child care & cell phone discounts; pet & legal insurance; credit union; referral bonuses. Those who meet service or hours requirements are also eligible for: 401(k) match; medical/dental/vision; HSA; health care FSA; life insurance; short/long term disability; paid parental leave; paid holidays/vacation/sick; auto/home insurance discounts; scholarship program; adoption assistance. All benefits are provided in accordance with and subject to the terms of the applicable plan or program and may change from time to time. Contact your TJX representative for more information. In addition to our open door policy and supportive work environment, we also strive to provide a competitive salary and benefits package. TJX considers all applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, gender identity and expression, marital or military status, or based on any individual's status in any group or class protected by applicable federal, state, or local law. TJX also provides reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local law. Applicants with arrest or conviction records will be considered for employment. Address: 153 Paseo De PeraltaLocation: USA HomeGoods Store 1070 Santa Fe NMThis position has a starting pay range of $15.40 to $15.90 per hour. Actual starting pay is determined by a number of factors, including relevant skills, qualifications, and experience.

  • Santa Fe, NM

  • no content

Outpatient Registered Nurse - RN

PURPOSE AND SCOPE: The professional registered nurse Outpatient RN CAP 1 is an entry level designation into the Clinical Advancement Program (CAP). This position is accountable and responsible for the provision and coordination of clinically competent care including assessment, planning, intervention and evaluation for an assigned group of patients. This may include delegation of appropriate tasks to direct patient care staff including but not limited to RNs, LVN/LPNs and Patient Care Technicians. As a member of the End Stage Kidney Disease (ESKD) health care team, this position participates in decision-making, teaching, leadership functions, and quality improvement activities that enhance patient care outcomes and facility operations. PRINCIPAL DUTIES AND RESPONSIBILITIES: All duties and responsibilities are expected to be performed in accordance with Fresenius Kidney Care policy, procedures, standards of nursing practice, state and federal regulations. · Performs all essential functions under the direction of the Supervisor and with guidance from the Clinical Educator, Preceptor or in collaboration with other Registered Nurses. · Performs ongoing, systematic collection and analysis of patient data pre – during – post hemodialysis treatment for assigned patients and documents in the patient medical record, makes adjustments or modifications to treatment plan as indicated and notifies Team Leader, Charge Nurse, Supervisor or Physician as needed. · Assesses, collaborates, and documents patient/family’s basic learning needs to provide initial and ongoing education to patients and family. · Directs and provides, in collaboration with direct and ancillary patient care staff, all aspects of the daily provision of safe and effective delivery of hemodialysis therapy to assigned patients. · Administers medications as prescribed or in accordance with approved algorithm(s), and documents appropriate medical justification and effectiveness. · Initiates or assists with emergency response measures. · Serves as a resource for health care team, participates in staff training and orientation of new staff as assigned. · Ensures correct laboratory collection, processing and shipping procedures are performed and reschedules missed or insufficient laboratory collections. · Identifies expected outcomes, documents and updates the nursing assessment and plan of care for assigned patients through collaboration with the Interdisciplinary Team. · Ensures patient awareness related to transplant and treatment modality options. · Required to complete CAP requirements to advance. · Performs all other duties as assigned by Supervisor. PHYSICAL DEMANDS AND WORKING CONDITIONS: The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. · The position provides direct patient care that regularly involves heavy lifting, moving of patients and assisting with ambulation. Equipment aids and/or coworkers may provide assistance. · This position requires frequent, prolonged periods of standing and the employee must be able to bend over. · The employee may occasionally be required to move, with assistance, machines and equipment of up to 200 lbs., and may lift chemical and water solutions of up to 30 lbs. as high as 5 feet. · The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. · May be exposed to infectious and contagious diseases/materials. · Day to day work includes desk work, computer work, interaction with patients, facility/hospital staff and physicians. · The position may require travel to training sites or other facilities. · May be asked to provide essential functions of this position in other locations with the same physical demands and working conditions as described above. SUPERVISION: Assigned oversight of Patient Care Technicians/LPNs/LVNs/RNs as a Team Leader or designated Nurse in Charge, after meeting all the following: · Successful completion of all FKC education and training requirements for new employees. · Must have a minimum of 9 months experience as a RN. · Must have a minimum of 3 months experience in chronic/acute hemodialysis as a RN. EDUCATION and LICENSURE: · Graduate of an accredited School of Nursing. · Current appropriate state licensure. · Current or successful completion of CPR BLS Certification. · Must meet the practice requirements in the state in which he or she is employed. EXPERIENCE AND REQUIRED SKILLS: · Entry level for RNs with less than 2 years of Nephrology Nursing experience as a Registered Nurse. · Chronic/acute hemodialysis experience (preferred). The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies. Hourly Rate: $36.00 - $50.00 Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave. Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. EOE, disability/veterans

  • Greeley, CO

  • no content

Medical Laboratory Scientist (MLS)

Hourly Pay Range: $30.46 - $45.69 - The hourly pay rate offered is determined by a candidate's expertise and years of experience, among other factors.Position Highlights: Position: Medical Laboratory Scientist (MLS) Location: Evanston Hospital Full Time/Part Time: Full Time Hours: Monday-Friday, 10:30pm-7am, e/o weekend and rotating holidays What you will do: Performs clinical lab testing in Chemistry, Hematology, Urinalysis, Coagulation. Special Coagulation, Immunology Bone Marrow and Flow Cytometry testing are performed on the day shift. Actively promotes patient satisfaction and customer service values with all staff members. Instructs and encourages coworkers to treat patients and customers (nurses, physicians, visitors, vendors etc.) courteously. Performs patient tests, manually and with automated clinical laboratory equipment, reagents and/or test methodologies. Reviews patient test results for accuracy and notifies appropriate clinical personnel or all critical results. Documents this notification per established protocols. Performs quality control per established departmental protocols. Records QC appropriately and takes corrective action when QC is not within established guidelines. Documents corrective action taken. Performs instrument checks, maintenance and troubleshooting per department protocols. Maintains competencies in accordance with policy and procedures of the hospital and laboratory department. Recognizes abnormal or unusual test results and makes appropriate decisions before releasing results. Notifies supervisor and pathologist if necessary. Participates in continuing education programs, in-services, lab meetings and various committees. Maintains a safe work environment by using required PPE and protective devices. Handles biohazardous materials and chemicals according to established protocols. Maintains inventory and supplies within respective departments. Performs computer functions efficiently, manages workload and established turnaround times. Assists in orientation and training of new employees and students. May assist in competency assessment of moderate and high complexity testing. Maintains a broad knowledge of all laboratory departments. May cross-train into other areas of the lab as needed. Reads emails and responds in a timely manner. Other projects or duties as assigned. What you will need: Education: Bachelor of Science, Biology or Chemistry Certification: MLS (ASCP) or equivalent Experience: Any Unique or Preferred Skills: Chemistry, Hematology, UA, Body Fluids, Coagulation Benefits: Premium pay such as shift, on call, holiday and more based on an employee’s job Incentive pay for select positions Opportunity for annual increases based on performance Career Pathways to Promote Professional Growth and Development Various Medical, Dental, Pet and Vision options Tuition Reimbursement Free Parking Wellness Program Savings Plan Health Savings Account Options Retirement Options with Company Match Paid Time Off and Holiday Pay Community Involvement Opportunities Endeavor Health is a fully integrated healthcare delivery system committed to providing access to quality, vibrant, community-connected care, serving an area of more than 4.2 million residents across six northeast Illinois counties. Our more than 25,000 team members and more than 6,000 physicians aim to deliver transformative patient experiences and expert care close to home across more than 300 ambulatory locations and eight acute care hospitals – Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights) Skokie and Swedish (Chicago) – all recognized as Magnet hospitals for nursing excellence. For more information, visit www.endeavorhealth.org. When you work for Endeavor Health, you will be part of an organization that encourages its employees to achieve career goals and maximize their professional potential. Please explore our website (www.endeavorhealth.org) to better understand how Endeavor Health delivers on its mission to “help everyone in our communities be their best”. Endeavor Health is committed to working with and providing reasonable accommodation to individuals with disabilities. Please refer to the main career page for more information. Diversity, equity and inclusion is at the core of who we are; being there for our patients and each other with compassion, respect and empathy. We believe that our strength resides in our differences and in connecting our best to provide community-connected healthcare for all. EOE: Race/Color/Sex/Sexual Orientation/ Gender Identity/Religion/National Origin/Disability/Vets, VEVRRA Federal Contractor.

  • Evanston, IL

  • no content

RN - Cardiovascular Unit - Nights

Hourly Pay Range: $36.00 - $55.80 - The hourly pay rate offered is determined by a candidate's expertise and years of experience, among other factors.Position Highlights: Position: Registered Nurse - Mixed Cardiac/Tele and Neuro/Stroke Unit Location: Elmhurst Main Hospital Campus Part-Time: 24/hr week Hours: 7pm – 7:30am (4-5 weekends in a 6 week period) and rotating holiday track What you will do: Demonstrates the knowledge and skills necessary to provide care appropriate to the age of patients served. This includes knowledge of the physical and psychological needs of patients served and the ability to respond appropriately to those needs. Provides virtual and bedside nursing to assigned patients. This includes monitoring and caring for patients. Communicates patient care information to the bedside RN. Acts as a knowledge resource to the bedside RN. May provide medication reconciliation, completion of procedure checklists, second nurse sign off for meds/skin checks, contacts families, answers questions for the patient and/or family, etc. Performs patient/family education and discharge planning. Documents patient interactions via EPIC What you will need: Required Education, Licenses/Certifications, Skills and/or Experience: Associate Degree or higher in NursingIf Associate Degree in Nursing is the highest degree held, must graduate with a Bachelor’s Degree in Nursing within five years of position start date (effective September 1, 2021) Current incumbents with an RN Diploma are grandfathered OR RN Diploma Nurse if position start date is prior to September 1, 2021 Current State of Illinois Registered Nurse licensure Current CPR Certification issued by the American Heart Association Advanced Cardiovascular Life Support (ACLS) within 6 months of start date in position Stroke Scale Certification (NIHSS) within in 6 months of start date in position Preferred Education, Skills and/or Experience: Bachelor’s Degree or higher in Nursing 1 year of bedside inpatient nursing experience in an acute care setting, highly preferred Benefits: Premium pay for eligible employees Career Pathways to Promote Professional Growth and Development Various Medical, Dental, Pet and Vision options Tuition Reimbursement Free Parking Wellness Program Savings Plan Health Savings Account Options Retirement Options with Company Match Paid Time Off and Holiday Pay Community Involvement Opportunities Endeavor Health is a fully integrated healthcare delivery system committed to providing access to quality, vibrant, community-connected care, serving an area of more than 4.2 million residents across six northeast Illinois counties. Our more than 25,000 team members and more than 6,000 physicians aim to deliver transformative patient experiences and expert care close to home across more than 300 ambulatory locations and eight acute care hospitals – Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights) Skokie and Swedish (Chicago) – all recognized as Magnet hospitals for nursing excellence. For more information, visit www.endeavorhealth.org. When you work for Endeavor Health, you will be part of an organization that encourages its employees to achieve career goals and maximize their professional potential. Please explore our website (www.endeavorhealth.org) to better understand how Endeavor Health delivers on its mission to “help everyone in our communities be their best”. Endeavor Health is committed to working with and providing reasonable accommodation to individuals with disabilities. Please refer to the main career page for more information. Diversity, equity and inclusion is at the core of who we are; being there for our patients and each other with compassion, respect and empathy. We believe that our strength resides in our differences and in connecting our best to provide community-connected healthcare for all. EOE: Race/Color/Sex/Sexual Orientation/ Gender Identity/Religion/National Origin/Disability/Vets, VEVRRA Federal Contractor.

  • Elmhurst, IL

  • no content

Director, Clinical Outcomes Assessment, Global Evidence & Outcomes (Hiring Immediately)

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 As part of the Global Evidence and Outcomes (GEO) team, this position is focused on documenting the patient value of Takeda's new medicines to contribute to the successful development and commercialization of new, innovative therapies across the oncology portfolio through: ACCOUNTABILITIES: Conduct qualitative and quantitative research to inform development on conceptual disease-models. Develop, assess and interpret COAs, including Patient-Reported Outcomes (PROs), Observer-Reported Outcomes (ObsROs) and Clinician-Reported Outcomes (ClinROs), and performance outcome (PerfO) measures to derive clinical benefit during the clinical development and commercialization of new molecules, including development and validation of PRO and health-related quality of life instruments. Represent the GEO function on corporate cross-functional teams, providing strategic input related to product development and commercialization to enable and support informed decision making. Generate patient insights about disease and treatment, and lead the development of COA measurement strategies to support clinical development, post-authorization and commercial research activities across the lifecycle of drug development with consideration for global stakeholder needs. Lead strategy development and evidence generation of COA-based support tools for patients and healthcare professionals in routine clinical practice using digital technologies. Work within a multidisciplinary, matrixed organization to develop and execute successful Oncology COA endpoint strategies for multiple assets. Prepare and/or review outcomes research protocols, statistical analysis plans (SAPs), and reports, with a specific focus on COAs. Prepare, review, and publish scientific reports reflecting ongoing or completed work Collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned. Perform relevant research activities that may include, but not be limited to: Design, execution, and analysis in whole or in part of longitudinal prospective observational or randomized clinical trials evaluating clinical, and/or patient-centered endpoints; Targeted or comprehensive systematic literature reviews. Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, regulatory and reimbursement dossiers and other communication mechanisms. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Combination of academic training and practical experience (oncology experience preferred) in outcomes research is required. This may be consist of: Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H.) in a relevant discipline such as, but not limited to, health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus 8 years practical experience Practical experience (number of years as noted above) in performing outcomes research, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required. A minimum of 5 years of Patient Reported Outcomes experience is required. Demonstrated experience in interpreting statistical analysis is required. Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required. Working knowledge of Patient Focused Drug Development (PFDD) Guidance documents and other relevant guidance documents and best practices is required. Ability to understand regulatory and HTA/payer challenges for Takeda products; and to critically review data and assimilate strategies that take such environments into consideration is required. Familiarity with the role and importance of outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is required. Experience should include the conduct of outcomes research studies, and the communication of study findings to internal and external audiences. Expertise and experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies is expected. Must be capable of leading teams, influencing teams, and driving decisions; must also be able to work effectively as a member of different teams. Experience with the drug development process in the pharmaceutical industry is strongly preferred. Regulatory understanding and experience in negotiating PRO label claims is strongly preferred. Experience with ePRO is strongly preferred. Oncology experience is highly desirable Ability to work collaboratively and effectively in a multicultural and cross functional team environment. Experience managing budgets is expected. Demonstrated expertise in patient-reported outcomes/health-related quality of life assessment is highly desirable. Experience in conducting outcomes research in different geographic regions and interacting with regulator and/or HTA/payer policy-makers is highly desirable. 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

Director, Global Regulatory Labeling Strategy (Hiring Immediately)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC. How you will contribute: Management of Labeling Cross-Functional Teams Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. In a highly efficient manner, 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. Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write- offs is minimized. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. 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. Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content. Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions, departments and regions. 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 inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals. 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. Embraces pivotal role in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. People Management Effectively manages resources and staff to ensure optimal performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities. Supports the professional development of staff members and effectively manages their performance. Demonstrate ownership to consistently drive the delivery of team goals fostering accountability while remaining focused on the big picture labeling strategy. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 10 years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6 years regulatory and/or related experience. Strategic Thinking Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives. Demonstrates a strong understanding of the core business aspect. Ability to effectively collaborate with global cross-functional reams and to deliver engaging and valuable presentations to diverse stakeholders. Ability to build a collaborative network of relationships across global cross-functional teams. Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format. Ability to advocate for regulatory decisions across global cross-functional teams. Ability to actively listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding. Analytical and Problem Solving Skills Demonstrates deep understanding of analytical methodologies and problem-solving technique to handle complex problems. Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues. Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities. Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately

  • Boston, MA

  • no content

Director, Regulatory Site CMC (Hiring Immediately)

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

Associate Director, Statistics (Hiring Immediately)

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 that will inspire you and empower you to shine? Join us as Associate Director, Statistics in our Cambridge, MA office. 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 realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda’s mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders. The R&D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda’s R&D pipeline. Central to Takeda’s R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics & Quantitative Sciences, Programming, Patient Safety & Pharmacovigilance, and Strategic Operations The Statistics and Quantitative Sciences (SQS) department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. POSITION ACCOUNTABILITIES: Lead delivery for one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Create an internal cross functional and external with vendors sphere of influence in predictable delivery Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: Must have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials: PHD with ~ 5 years experience MS with ~ 8 years experience Technical Skills: Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics Scientific understanding of drug R&D to inform methodological input with product team or in a platform Strong communication skills and ability to translate effectively across functional lines Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs Enable the tactical execution of the SQS and DQS vision and mission Lead and be accountable for asset level strategies being implemented Demonstrate mentorship, matrix or direct management of small team of SQS colleagues Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D Create an internal and external sphere of influence in area of expertise This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. LI-JV2 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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 Affairs CMC (Hiring Immediately)

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. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) and may serve as the GRA CMC Product Lead, as required. Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug product or suite of products is preferred. Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle. Demonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. Successfully communicates and negotiates with Health Authorities – directly and indirectly. Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. Acts as mentor / coach to other GRA CMC members. How you will contribute: Develops, executes and oversees the preparation of major global registrational submissions. Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters. Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required. Fosters constructive working relationships when interacting with internal and/or external colleagues. Providing strategic input into change control evaluation - as required. As a GRA CMC member, ensures and / or enhances regulatory compliance. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Proactively identifies regulatory CMC risks, ensuring timely communication with line management. Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations. Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target. Supports development of strategies, tools, and trainings to further the GRA CMC roadmap. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required. 10 years of overall biopharmaceutical/device industry experience with 8 years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. Strong 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. Base regulatory strategy recommendations 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. Applies direction 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. Exercises good judgement in elevating and communicating actual or potential issues to line management. 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) pl

  • Cambridgeport, MA

  • no content

Associate Director, Quantitative Clinical Pharmacology (QCP) Lead (Hiring Immediately)

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 that will inspire you and empower you to shine? Join us as Associate Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA office. 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 realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: 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 clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) 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 DQS, 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 the pharmacometrics lead to drive a MIDD path within each project. 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. Possesses primary responsibility for dosage selection and generation of causality evidence. Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives. Explores and excels in synergistic relationships with experts in 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. POSITION 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. Be charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum. 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 be 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. Mentors junior staff to promote scientific excellence and individual achievement. Participates as a member of Business Development due diligence, when requested. Contributes to infrastructure initiatives and/ or cross-functional best practice initiatives. Has scientific influence outside QCP and Takeda through presentations and publications and active contribution to scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: Pharm D. or PhD with 5 years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD MS with 8 years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD Technical Skills: Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies. Formulates and executes clinical pharmacology plans including integration of MIDD principles. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across different regions (ICH, FDA, EMA and others). Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making. Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics. Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy. This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. LI-JV2 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creat

  • Cambridgeport, MA

  • no content

Associate Director, Global Regulatory Affairs CMC (Hiring Immediately)

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. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. Has a strong and deep foundational understanding of global RA CMC regulations and guidelines. Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions. Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. Successfully communicates and negotiates with Health Authorities – directly and indirectly. Able to apply GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. How you will contribute: With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters. Interacts directly with international Health Authorities on administrative procedural topics, as required. Fosters constructive working relationships when interacting with internal and/or external colleagues. Evaluates change proposals for global regulatory impact. As a GRA CMC member, ensures regulatory compliance with HA regulations. Assures conformance with Takeda controlled procedures and GRA CMC best practices. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Supports and/ or leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. 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 5 years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered). 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. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Applies decisions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies the given prioritization framework with limited support. Excellent written and oral communication skills required. Exercises good judgement in elevating and communicating actual or potential issues to line management. 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: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

  • Cambridgeport, MA

  • no content

Associate Director, Global Regulatory Affairs - GI & Inflammation (Hiring Immediately)

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 Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Associate Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. Education & Competencies: Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 6 years of pharmaceutical industry experience. This is inclusive of 4 years of regulatory experience Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates strong skills with increasing independence in the area of 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. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of 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. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type 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

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