Finance

Remote-Ready Retail Pharmacist (RALEIGH)

Job Summary *This role will be based out of our various retail locations throughout North Carolina along with one day per week working from home supporting centralized services.* Responsible for ensuring the proper compounding, dispensation, review, and verification of prescribed medications within regulatory guidelines, company policies and procedures. Works effectively in a hybrid work environment (such as Pharmacy store, Call Center, Micro-Fulfillment, and/or remote) and provides pharmacy consulting services with empathy to patients regarding the effective usage of medications and awareness of drug interactions leveraging omni-channel services (e.g., in person consultation and via the phone). Offers preventive and clinical healthcare services, including immunizations, diagnostic testing, and patient outcomes services. Supports the efficient workflow of the pharmacy and assists the pharmacy management in identifying ways to optimize pharmacy financials, inventory management and enhance the patient experience. Job Responsibilities Performs pharmacist tasks, including compounding, drug therapy reviews, verification, and medication management. Reviews, interprets and dispenses prescribed medications. Enhances patient experience by focusing on healthcare services (e.g., patient consultation, medication management, drug therapy reviews) and retail, clinical, or wellness services such as immunizations, disease state management and specialty programs. Listens to patients concerns and issues, acts as a sounding board for pharmacy concerns and provides feedback to operations leaders. Resolves customer queries and issues in a timely manner to ensure a positive customer experience. Conducts centralized support, including patient registration, exception resolution, and assists with resolving patient issues. Performs in-person or virtual product/prescription reviews, within guidelines. Provides expertise, resources, education and support to broader team. Supports staff training and development opportunities. Promotes teamwork and motivates staff by fostering a shared vision; Supports company policies, procedures, mission, values, and standards of ethics and integrity. Partners with leadership team in analyzing performance (KPIs), financial and customer service data; Implements procedures for pharmacy asset protection and inventory management. Ensures the pharmacy adheres to regulations, company policies and standards. Collaborates with leaders to establish workflow procedures (e.g., assigning roles, coordinating activities and soliciting employee suggestions). Oversees pharmacy opening, closing and shift change. Maintains and develops relationships with medical providers and other health professionals. Ensures pharmacy staff follows up with medical providers’ to clarify prescriptions, dosages, refills, interactions and allergies, to suggest alternative medications and answer questions. Maintains current knowledge of pharmacy systems technology (e.g., workflows, prescription fulfillment, billing, clinical documentation, training, inventory management, and POS registers). Processes insurance claims. Liaises with insurance companies, medical providers and auditors. Develops and maintains relationships with the local medical community, including physicians, nurses, and other healthcare providers. Participates in community outreach activities to promote the pharmacy business and enhance growth opportunities. Participates in community events that reflect the unique communities we serve as requested by leadership team. Drives compliance and continuous improvement in the delivery of clinical pharmacy patient care and services by studying, evaluating, and re-designing processes; monitoring and analyzing results; and implementing changes. Adheres to regulatory compliance and standard operating procedures. Maintains awareness of third-party pharmacy business opportunities and assures proper administration and implementation of pharmacy systems and procedures. Seeks professional development and solicits feedback. Maintains current knowledge and required licensing/credentialing/certification as established by federal and state regulations. Stays current with pharmacy trends and best practices. About Walgreens Founded in 1901, Walgreens (www.walgreens.com) proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for pharmacy, retail and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities. LI-SC1 Basic Qualifications BS in Pharmacy or Pharmacist Degree from an accredited educational institution. Current Pharmacist license as granted by the appropriate state licensing authority. Experience performing prescription dispensing activities, demonstrating a strong working knowledge of applicable state and federal controlled substance laws. Certified Immunizer or willing to become an immunizer within 90 days of hire. Willing and able to work effectively in different and/or multiple work environments (such as Centralized Services, Retail Pharmacy, Specialty Pharmacy, and/or virtual). Preferred Qualifications At least 1 year of pharmacy experience, including prescription filling and verification, records and legal compliance, pharmacy operations, pharmacy software and technology systems and insurance.

  • Mccullers, NC

  • no content

Board Certified Behavior Analyst (Quincy)

Description: You've found a great opportunity to work at an established and dedicated ABA company! What are we looking for? Board Certified Behavior Analyst, Full-Time Center-based: Enjoy the stability and consistency of working at a center! Schedule: Monday-Friday (no weekends!) Location: Quincy Center What do we offer? Competitive Pay Paid Time Off: We offer generous vacation, sick and personal time so that you can have a great work-life balance Benefits: Insurance, HSA, 401k, referral program, tuition reimbursement and more A team that is inclusive, team-oriented and focused on advancing skills and careers. Position Summary An SSAC Behavior Analyst is an experienced BCBA who demonstrates strong clinical skills, commitment to supervising a team of behavior therapists, and excellent communication with parents, supervisors and supervisees. Maintains a caseload of clients as determined by the Clinical or Executive Director and carries out all clinical services for each client. Collaborates with other BCBAs and the Clinical Director of the Program and supervises all Behavior Therapists who work with their clients. Demonstrates leadership providing insight and contributions to ensure the company’s mission and values infuse the daily operations and ongoing success of the Program. Essential Job Functions/Responsibilities The essential functions include, but are not limited to the following: Client-specific oversight, initial assessment, treatment plan writing, reassessments, gather and maintain session schedule, caseload supervision/management Supervise Behavior Therapists Monitor data Write, modify, train on programs Serve as the main point of contact for each family; communicate with parents: daily/weekly updates, progress, concerns Facilitate client transition to new team when clinically appropriate Provides school consultation Collaborate with other providers/professionals, provide individual parent training, and group parent training Provide leadership, train new Behavior Therapists, provide mentorship to other BCBA’s in program, collaborate with Clinical or Executive Director for program-wide needs, questions and plans, meet with other BCBAs and Clinical Director/Executive Director for individual and program-wide collaboration and support Contribute to site-specific and company-wide projects and tasks as directed Participate in clinical meetings, staff meetings, and professional development Protect the confidentiality of the client and family Benefits include, but are not limited to: Health Insurance Dental Insurance Vision Insurance Accident Insurance Company funded Life Insurance Health Savings Account 401K Paid time off including vacation, personal and sick time Paid holidays Competitive pay rate Paid training Mileage reimbursement Referral program Tuition reimbursement Company provided tablets Advancement opportunities Visit us @ www.ssautismcenter.com AMERICANS WITH DISABILITIES ACT South Shore Autism Center complies with all aspects of the Americans with Disabilities Act (ADA) and state disability laws. This means that we will not discriminate against qualified individuals with a disability in any phase of the employment relationship including application for employment, hiring, promotions and/or advancement opportunities, termination, compensation, training and any other conditions or privileges of employment. Requirements: Master’s degree in applied behavior analysis, education, psychology, or related field required BCBA certification and Massachusetts license (LABA) One (1) plus years of BCBA experience or newly certified BCBA At least three (3) years of ABA experience or working with individuals with developmental disabilities At least three (3) years of experience working with children with autism ages 14 and younger, including toddlers Access to two recent redacted writing samples demonstrating clinical skills (Functional Behavior Assessment, Treatment Plan, Behavior Support Plan, Instructional Program) Two (2) references from a professional or academic supervisor Reliable transportation and a valid driver’s license Physical ability to occasionally lift, transport clients or equipment weighing up to 40 pounds; physical ability to move quickly to follow clients when walking or running Must consent to a criminal background investigation Travel to clients’ homes on the South Shore as needed WORKING CONDITIONS AND PHYSICAL EFFORT The work environment characteristics described here are representative of those a Behavior Therapist encounters while performing the essential functions of this job. Physical Demands/Efforts Work performed requires extended periods of walking and standing and constant movement throughout the day, e.g. this is not a seated or stationary position Work may require assisting clients as necessary, including but not limited to: grooming/ hygiene routines, eating routines and responding to behavioral incidents Work may require occasional physical exertion including stooping, kneeling, crouching, and some lifting of objects weighing up to 40 pounds Work may require staff to sit or kneel on the ground with clients including the ability to quickly rise to a standing position if needed This company utilizes Safety Care procedures. All staff are required to complete and pass company provided training Compensation details: 75000-90000 Yearly Salary PIb332605b4b77-38003-40336398

  • Quincy, MA

  • no content

ADA Associate/Specialist (Phoenix)

Description: Job Title: ADA Associate Reports To: Operations Manager FLSA Status: Non-Exempt Salary Range : $50,000 - $60,000 Job Location: As a remote-first organization, employees are expected to primarily work within reasonable driving commute to our main office locations (Roseville CA, Atlanta GA, Phoenix AZ, and Oklahoma City OK) to meet the requirements of team gatherings, one-off meetings, and company-wide events, as well as the legal, tax, and security regulations based on our business operations. Note: We do not have a physical office location in Phoenix at present (but we may acquire one in the future). Therefore, initially this position would be fully remote. Employees are expected to live within a reasonable driving commute of the Phoenix area and report to the office bi-weekly if an office is acquired in Phoenix in the future. Job Summary: The ADA Associate is an individual contributor delivering Gold Standard leave and ADA services to our clients and their employees. This role focuses on gaining a foundational knowledge of administering leaves of absence and at work accommodations, with special focus on engaging in the interactive discussion process. Key Responsibilities: Gold Standard ADA Administration & Primary Point of Employee Contact Administer a full workload of ADA cases and associated leaves of absence for multiple clients, per client policies, while adhering to federal and state leave law regulations with special attention to the interactive discussion process as outlined under the Americans with Disabilities Act. Remain the primary point of contact for employees with any open service outside of their ADA case (i.e. protected or company policy leave along with an at work accommodation). Leave administration includes, but is not limited to, confirming leave eligibility, reviewing medical documentation, communicating with healthcare providers, client employees and members of the HR team, and confirming return-to-work. ADA administration includes, but is not limited to, engaging in the interactive discussion process on behalf of the client, documenting the process, seeking clarification as necessary, and acting as a resource for a client as they assess the request for accommodations on a case-by-case basis. Provide excellent customer service by answering phones, responding to emails, and communicating effectively with clients’ employees in a timely manner - answering questions regarding leave entitlement, client policies, and benefits. Coordinate effectively with Claim Specialists to ensure that employee claims are adjudicated timely and accurately. Draft and send letters to employees regarding leave entitlement, disability benefits, and/or the interactive discussion process. When applicable, initiate return-to-work accommodations while adhering to relevant federal regulations. Maintain high quality employee leave and ADA files according to set standards. Internal Partnership & Team Contribution Expected to be a self-starter who can work independently, take initiative, actively participate in team discussions and collaborate effectively while working in a remote-first environment. Coordinate effectively with Claim Specialists to ensure that employee claims are adjudicated timely and accurately. Able to take on additional work with short notice (e.g. client needs to be taken over on short notice due to business needs). When required, coordinate between short-term disability insurance carriers, worker’s compensation insurance providers, and the employee. Participate in client meetings, company-wide off-site meetings, and training programs which may require some infrequent travel. Available to back up multiple accounts. Perform other duties as assigned in order to meet business needs. Job Title: ADA Specialist Reports To: Operations Manager FLSA Status: Non-Exempt Salary Range : $55,000 - $73,000 Job Summary: The ADA Specialist constantly strives to provide the highest levels of ADA service to our clients and their employees while gaining experience handling a variation of leave types to develop in-depth knowledge of leave administration and the interactive discussion process. Key Responsibilities: Gold Standard ADA Administration & Primary Point of Employee Contact Administer a full workload of ADA cases and associated leaves of absence for multiple clients, per client policies, while adhering to federal and state leave law regulations with special attention to the interactive discussion process as outlined under the Americans with Disabilities Act. Remain the primary point of contact for employees with any open service outside of their ADA case (i.e. protected or company policy leave along with an at work accommodation). Leave administration includes, but is not limited to, confirming leave eligibility, reviewing medical documentation, communicating with healthcare providers, client employees and members of the HR team, and confirming return-to-work. ADA administration includes, but is not limited to, engaging in the interactive discussion process on behalf of the client, documenting the process, seeking clarification as necessary, and acting as a resource for a client as they assess the request for accommodations on a case-by-case basis. Provide excellent customer service by answering phones, responding to emails, and communicating effectively with clients' employees in a timely manner - answering questions regarding leave entitlement, client policies, the interactive discussion process, and benefits. Draft and send letters to employees regarding leave entitlement, disability benefits, and/or the interactive discussion process. When applicable, initiate return-to-work accommodations while adhering to relevant state and federal regulations. Maintain high quality employee leave and ADA files according to set standards. Internal Partnership & Team Contribution Expected to be a self-starter who can work independently, take initiative, actively participate in team discussions and collaborate effectively while working in a remote-first environment. Coordinate effectively with Claim Specialists to ensure that employee claims are adjudicated timely and accurately. Able to take on additional work with short notice (e.g. client needs to be taken over on short notice due to business needs). When required, coordinate between short-term disability insurance carriers, worker’s compensation insurance providers, and the employee. Participate in client meetings, company-wide off-site meetings, and training programs which may require some infrequent travel. Available to back up multiple accounts. Able to administer for clients across multiple pods. Requirements: Experience, Skills, and Core Competencies: ADA Associate Education & Technical Skills: Four-year college degree in a similar/related field. Proficient in typing and MS Word, with strong organizational, quantitative, and verbal/written communication skills. Regulatory & Policy Knowledge: Ability to comprehend and interpret various informational and regulatory documents (e.g., disability plans, client leave policies, state/federal regulations) and stay abreast of any changes. Professional Conduct: A passion for excellent customer service, effective communication with all stakeholders, and a team-oriented approach to building strong working relationships. Growth Mindset: Willingness to learn, take initiative to understand underlying reasons, and be receptive to feedback for continuous improvement. Work Habits: Excellent attention to detail, follow-through, and common sense. Strong ability to prioritize tasks, manage time well, identify and solve problems efficiently, and maintain accurate records. Expected to work 40 hours per week. Expected to report to the office bi-weekly Perform above duties between regular business hours: California: Monday to Friday, 8am to 5pm (PST) Georgia: Monday to Friday, 8am to 5pm (EST) Arizona: Monday to Friday, 8am to 5pm (MST) Oklahoma: Monday to Friday, 8am to 5 pm (CDT) ADA Specialist Education & Expertise: Four-year college degree in a similar/related field; proven ability to seamlessly administer basic leave types. Technical Proficiency: Proficient typing and strong knowledge of MS Word. Core Skills: Strong organizational, quantitative, and verbal/written communications skills. Requires excellent attention to detail, follow-through, and common sense. Aptitude: Ability to comprehend and interpret complex legal and client documents (disability plans, policies, state/federal regulations) and stay current on all relevant changes. Work Ethic: Must be passionate, proactive, team-oriented, receptive to feedback, take initiative, prioritize tasks, and manage time effectively. Expected to work 40 hours per week. Expected to report to the office bi-weekly. Perform above duties between regular business hours: California: Monday to Friday, 8am to 5pm (PST) Georgia: Monday to Friday, 8am to 5pm (EST) Arizon

  • Phoenix, AZ

  • no content

CVN Licensed Therapist (TAMPA)

CVN Clinician Who are we? For over fifty years, Aspire Health Partners has been one of the leading non-profit behavioral health companies in the Southeast. Serving nearly 40,000 clients per year, with locations in six Central Florida counties and currently expanding into Hinesville, Georgia Aspire has delivered state-of-the-art behavioral healthcare and is regularly sought out both statewide and nationally as an expert in the field. With its mission of providing the highest quality of compassionate, comprehensive, and cost effective integrated behavioral healthcare, Aspire, through its more than two dozen campus locations provides a comprehensive continuum of services for children, adolescents, adults, seniors, and families. Through innovative, resourceful treatment and recovery approaches Aspire offers individuals and families the opportunity to aspire to healthier, happier, and more independent lives. Aspire employs more than 1,200 professionals and paraprofessionals dedicated to Saving Lives, Transforming Communities and Changing the World Who You Are: You're a leader looking for an opportunity to define your own career path , connect with a supportive community of health professionals like you, and increase your earning potential. You have a passion for working in different care settings and making a difference in lives. Job Purpose: The CVN Clinician will provide evidence based, time-limited practices in an outpatient clinic that serves individual adults, couples, families, and children. The clinician will provide evidence-based treatment to Post 9/11 veterans, particularly those who served in Iraq and Afghanistan wars, and their families. Job Functions Provide evidence-based treatment to veterans, particularly those who served in the Iraq and Afghanistan wars, and their families (i.e., spouses, partners, parents, and children). This includes individual, couples and family therapy to adults, adolescents and children. Perform and document patient screenings, psychosocial assessments, and progress and referral information. Conduct clinical intake assessments on veterans and family members as needed. Provide individual, couples, and family psychotherapy to patients, with a focus on delivering evidence-based treatments. Collaborate and coordinate with the caregiver, physician, case management and all other disciplines to provide the best care to patient as needed. Attend weekly clinical, supervision, and administrative meetings. Work with leadership to establish training and development plans for clinical staff. Implementation of evidence-based practices with fidelity. Maintain appropriate case load. Participate in treatment team meetings. Provide Quality Assurance and regulatory compliance to client files (paper & electronic). Prepare and submit weekly and monthly program report to Lead Clinician. Provide services via telehealth platform, as required. Position qualifications: Ability to receive and maintain a(n) Level II Background clearance- All Aspire Health Partners Internships and Careers require Level 2 clearance, with Aspire covering fingerprinting costs. Click https://info.flclearinghouse.c to learn more. Acceptable Motor Vehicle Registration driver's license record in accordance with the underwriting guidelines set by Aspire insurance company as described in the AHP Corporate Transportation Policy 3.9.1 Master's Degree in clinical field, Minimum of 5 years of experience in a clinical setting. Experience with assessment and treatment of adults, children, couples, and families. Customer service skills Knowledge in DSM-IV/DSM-V diagnoses Knowledge of evidence-based practice, including manualized treatment modalities and measurement-based care. Experience in PTSD diagnosis and treatment and other traumas Experience in substance use disorders preferred. Experience working with military population and/or veterans or Department of Veterans Affairs and/or Department of Defense. Military Veterans are strongly encouraged to provide and will receive preference. Bilingual (English/Spanish) preferred. All the benefits and perks you need for you and your family: We are committed to providing our employees with the support they need. At Aspire Health Partners, we offer eligible staff an attractive benefit package that includes medical, wellbeing, dental and vision benefits along with some unique benefits including: Medical, Dental, Vision, Basic Life & Supplemental Insurance, Flexible Spending & Health Savings Accounts Paid Time Off (PTO) (2.5 weeks your first year, up to 6 weeks at 14 years) Paid Diversity & Floating Holidays (2) Paid Holidays (6) 403(b) 50% employer match up to 10% (3-year vesting cliff) Employee Discounts including Tickets, Retail, Hotel, Car Rental/Purchase Short-Term & Long-Term Disability Insurance HRSA Loan Forgiveness Employee Assistance Plan (EAP) Will preparation Funeral Planning Concierge Services & Travel Assistance PIe08ccbabd944-38003-37700805

  • Tampa Palms, FL

  • no content

Superintendent (Charlotte)

Position Title: Construction Superintendent Location: Charlotte, NC Job Category: Field Operations Pay Range: N/A Application Instructions Apply today! Position Description About Us At Barringer, we build more than beautiful commercial spaces — we build lasting relationships, memorable experiences, and the kind of craftsmanship our clients brag about. As a Carolinas-based commercial general contractor with offices across Asheville, Charlotte, Greenville, and Raleigh, we're proud to be 100% employee-owned and named the 1 Best Employer in North Carolina by Business NC Magazine two years running (2024 and 2025). Our work spans corporate interiors, hospitality, life sciences, healthcare, industrial, and more — guided by our core values of generosity, authenticity, honesty, and passion. We're looking for an experienced Superintendent to lead our jobsites the Barringer Way — with discipline, heart, and a craftsman's eye. You'll be the steady hand in the field, setting the tone for safety, quality, and client experience from first pour to final walkthrough. As an employee-owner, you'll share in our success while enjoying 100% employer-paid premiums for dental, vision, short-term disability, and life insurance, a 401(k) with company match, flexible PTO after your first year, tuition reimbursement, a wellness program, pet insurance, and annual donations to your favorite charity. Apply today! What You'll Do As a Superintendent, you'll own daily jobsite leadership — running the field, coordinating trade partners, and serving as the face of Barringer to clients, building occupants, and the design team. You'll work hand-in-hand with Project Managers to keep projects aligned with design intent, schedule, budget, and our mint-on-the-pillow client experience. Lead all daily field operations, setting the pace and standard for safety, quality, and productivity. Coordinate and hold subcontractors accountable to the schedule, scope, and Barringer's quality expectations. Read and interpret plans and specs, solving problems on the fly when the unexpected shows up. Communicate clearly and often with clients, building occupants, PMs, and design partners — no surprises. Maintain a clean, organized, and safe jobsite that reflects the Barringer name. Manage project schedules, look-aheads, and trade sequencing to keep work flowing. Document daily progress, deliveries, and field conditions; flag issues early. Mentor assistant supers and field staff, passing along the craft and the culture. Position Requirements What You Bring A leader's presence — confident with clients, respected by trade partners, and trusted by your team. Sharp problem-solving instincts and the judgment to make the right call in the moment. A relationship-first mindset with the professionalism to represent Barringer at the highest level. Pride in craftsmanship and attention to the details that separate good from great. Experience 10 years as a Superintendent with a commercial general contractor. Proven track record running projects from groundbreaking through closeout. Experience across a range of commercial project types preferred. Skills & Tools Strong ability to read and interpret construction drawings, specs, and schedules. Proficiency with Procore; familiarity with Bluebeam and Microsoft Office. Solid understanding of OSHA standards and jobsite safety practices. Physical Demands Able to navigate active construction environments including stairs, ladders, scaffolding, and uneven terrain. Comfortable on your feet for extended periods and able to lift up to 50 lbs. Clear vision and hearing to safely operate in and around active work areas. Work Environment Primarily jobsite-based, indoors and outdoors, with varying temperatures, dust, noise, heights, and machinery. Early mornings are the norm; occasional nights and weekends as project demands require. Valid driver's license and reliable transportation to jobsites required. Equal Opportunity Employer The policy of Barringer Construction is to approach recruiting, hiring, promotion, compensation and professional development practices without regard to race, religion, color, national origin, sex, age, creed, handicap, veteran status, sexual orientation or any other characteristic protected by law. We are fully committed to the principles of equal employment. All employees are expected to participate in helping the Company maintain a climate that is free of workplace harassment and provides equal opportunity for all. All forms of harassment by employees, vendors, visitors, customers, and clients are strictly prohibited and will not be tolerated. This includes sexual harassment and other forms of workplace harassment based upon an individual's sex, gender, race, religion, color, national origin, physical or mental disability, genetic information, marital status, age, sexual orientation, gender identity, AIDS/HIV status, military service, veteran status, or any other status protected by federal, state, or local laws. PI0aee3ab4999a-38003-40449978

  • Pineville, NC

  • 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

ELECTRICIAN-ONSITE (Brewerton)

Description: Base Hourly : $20.00-$45.00/Hour Reports to – Production Manager Annual Bonus : No Direct Reports – None Remote: No Status – Non-Exempt Company Website: www.schneiderequip.com ABOUT SCHNEIDER At Schneider Packaging Equipment Company, Inc. (“Schneider”), we believe innovation starts with the consumer. This approach has propelled our success in developing real-world solutions that allow us to automate the supply of life’s products. With over 50 years of industry problem-solving in end-of-line automation, Schneider is a leading manufacturer of case packing and robotic palletizing solutions. Headquartered in Upstate New York, we design state-of-the-art machinery for customers in industries such as: food and beverage, dairy, pharmaceutical, personal care, plastics, and paper. Schneider is now a part of the Pacteon family of companies. Our continued growth has allowed us to really be our Customer’s one source for end of line packaging solutions. ABOUT PACTEON Pacteon Group provides one source for best-in-class automation focused on end of line packaging solutions, providing the highest-level customer experience. Through a broad range of robotic and non-robotic equipment, ability to integrate solutions seamlessly across portfolio companies, and full sales and service coverage, Pacteon is uniquely positioned to design flexible and custom solutions for your automation needs. For more information on Pacteon, please visit www.pacteon.com . OUR CORE VALUES We believe and live our Core Values, our IPACT: I ntegrity P ride A ccountability C ustomer Service T eamwork Our Pacteon Promise is “We make it right”. As our customer’s one source for end-of-line packaging solutions, everyone plays an important role to make that happen. We provide internal growth paths for our employees and support them in their professional development goals. Diversity is important to us; we are proudly an Equal Opportunity Employer striving for innovation and growth both for our employees and our Company. SUMMARY AND PURPOSE Plan and perform a variety of electrical assembly operations working from controls schematics / drawings and specifications following detailed instructions. KEY RESPONSIBILITIES · Plan and perform a variety of electrical assembly functions utilizing precision instruments, hand tools, work from controls drawings/schematics following documented procedures with general guidance. · Document changes to Controls drawings/schematics. · Perform I/O inspection functions following company policies and procedures. · Use hand tools and basic power tools such as drills, grinders, and bandsaws. · Collaborate with Assembly and Controls personnel to troubleshoot equipment. · Complete electronic labor reporting. · Assist other electricians in electrical assembly operations and procedures. · Contribute to the continuous improvement of the electrical assembly team and its functions. · Perform other related duties as required by management. · Potential travel with equipment for installation. Requirements: PROFESSIONAL QUALIFICATIONS · Education: o Three to five years’ experience in similar industry/custom machine-building manufacturing experience desired. o High School diploma or equivalent required. A.A.S. in electronics or electrical technology or advanced training in electrical technology. · Experience: o Ability to read schematics (AutoCAD Electrical preferred). o Familiarity with NEC/NFPA70E. · Skills: o Detail oriented and accurate. o Ability to operate computer (Microsoft Suite). o Ability to perform I/O inspections. BENEFITS · Medical/HSA/FSA · Dental · Vision · 401k · Company paid Life and AD&D · Optional Life Insurance · Flexible Work Schedule PHSICAL REQUIREMENTS & WORK REQUIREMENTS Physical Requirement Never Sometimes Frequently Sitting X Standing/Walking X Lifting/Carrying Upto 10 lbs X Lifting/Carrying Upto 30 lbs X Pushing/Pulling X Keyboarding X Gross Manipulation X Fine Manipulation X Driving X Stooping X Speaking X Hearing X Near Visual Acuity X Compensation details: 20-45 Hourly Wage PIf364202edc6d-38003-39073609

  • Brewerton, NY

  • no content

Director, Commissioning and Project Execution (Richmond)

Position Overview The Director, Commissioning & Project Execution, is a senior technical and program leadership role responsible for overseeing and executing commissioning programs for critical power infrastructure within the data center market. The role serves as the customer’s primary project and technical point of contact for commissioning and field service activities This role blends hands-on field expertise with program management, technical governance, and team leadership to ensure safe, reliable, and high-quality delivery of commissioning and other onsite services across factory and field environments The Director, Commissioning & Project Execution will lead a team of field service project managers with responsibility for team management and overseeing performance of the Field Service PM’s assigned projects – schedule, cost, and financial results The role also plays a key role in the standardization of processes, training, and continuous improvement services initiatives across the Forgent portfolio, which is critical to scaling the business. The position is initially focused on the physical support of the Richmond data center market with travel to other large data center project locations over time Program & Field Execution • Manage and execute remote and onsite commissioning programs while remaining actively engaged in both manufacturing and deployment environments. • Provide hands-on technical support during equipment commissioning, testing, electrical tie-ins, system energization, and troubleshooting activities. • Support onsite commissioning activities as required to meet customer schedules, contractual commitments, and operational milestones. • Serve as a technical resource to Project Managers, ensuring alignment between project execution, commissioning scope, and customer expectations. • Provide on-call technical support to respond to critical issues and deliver timely guidance outside of normal business hours when required Technical Leadership & Escalation • Act as the primary technical escalation point for field service and commissioning teams. • Support troubleshooting on complex electrical and controls systems, lead repairs, and guide resolution of critical power system issues. • Perform root cause analysis of equipment or system failures and drive corrective and preventive actions. • Partner with vendors and OEMs for equipment validation, installation support, and advanced troubleshooting. Commissioning Standards & Documentation • Develop, review, approve, and maintain commissioning procedures, work instructions, and test protocols for both factory and field activities. • Prepare project commissioning test scripts for designated equipment and scopes of work. • Assist with the development & refinement of factory testing standards and acceptance criteria. • Attend factory testing of equipment scheduled for deployment and provide structured feedback to engineering and quality teams. • Develop and maintain standardized commissioning templates for all electrical equipment within the Forgent portfolio. • Ensure commissioning procedures and results support safe operations, regulatory compliance, and customer requirements. Reporting & Tools • Track commissioning activities across assigned projects and prepare comprehensive commissioning reports and closeout packages. • Utilize commissioning and testing software platforms such as CxAlloy, PowerDB, or equivalent tools to support commissioning activities and documentation. • Participate in regular commissioning (Cx) meetings for assigned projects and provide status updates, risk identification, and mitigation plans. Cross-Functional Coordination • Coordinate closely with product engineering, quality, manufacturing, operations, and field service teams to ensure seamless execution. • Interface with general contractors, subcontractors, owner’s representatives, and other onsite stakeholders during commissioning activities. • Provide a structured feedback loop to engineering and manufacturing teams to drive continuous improvement in equipment quality, testing procedures, and field performance. Coaching, Mentoring & Services Project Leadership • Lead, train, and mentor a team of field service project managers fostering a culture of technical excellence, accountability, and safety. • Accountable for performance management of field service project management team · Develop and oversee training programs to enhance technical competency, safety awareness, and professional growth of field service project management teams. • Identify training & certification opportunities for field service project managers. • Identify needs for additional field service project managers and develop business cases to support hiring and resource expansion. Services Project Oversight & Financial Management • Provide overall oversight of assigned services projects, ensuring execution on schedule, within approved budgets, and aligned with contractual scope. · Lead and support Field Service Project Managers in developing and maintaining detailed project plans, resource forecasts, and risk mitigation strategies. · Establish and enforce project controls for schedule adherence, cost management, change control, and margin protection across all services engagements. · Partner closely with Finance to ensure accurate percent-complete revenue recognition, including timely updates to project cost-to-complete, earned revenue, and forecasted margins. · Support services project forecasting, backlog reporting, and financial review cycles, providing clear visibility to leadership on performance, risks, and corrective actions. · Ensure consistent and timely project status, financial, and performance reporting to internal stakeholders and executive leadership. Required Qualifications • Minimum 12 years of mission critical infrastructure experience, including at least 6 years supporting data center environments. • Minimum 5 years of hands-on electrical testing and commissioning experience in critical power environments. • Four-year ABET-accredited degree in Engineering or Engineering Technology (Electrical or Mechanical preferred). • Demonstrated experience commissioning medium- and low-voltage power systems including switchgear, UPS systems, generators, and associated controls. • Strong understanding of safety practices including lock-out/tag-out (LOTO), arc flash mitigation, and commissioning best practices. • Ability to lead teams, mentor technical staff, and manage multiple commissioning efforts concurrently. • Strong communication skills with the ability to interface effectively with customers, contractors, vendors, and internal teams. Preferred Qualifications • Professional Engineer (PE) licensure in Electrical or Mechanical Engineering. • Project Management Professional (PMP) certification. • Hyperscale, AI, or high-performance computing (HPC) data center construction, commissioning, and operations experience. • Prior experience serving as a Commissioning Agent (CxA) or lead commissioning engineer. • Familiarity with IEEE, NFPA, NETA, UL, and IEC standards. • Experience with commissioning platforms such as CxAlloy, PowerDB, or equivalent tools. Work Environment • Regular onsite presence with periods of working remote • Combination of office, factory, and active construction site environments. • Initial travel requirements are limited with focus on the Richmond VA area, but will increase over time to support large projects in other areas LI-EC1 PIed8c7a8db0bb-38003-40499932

  • Capitol, VA

  • no content

Audiologist (CCC-A) (Valhalla)

AUDIOLOGIST (CCC-A) Valhalla, NY About the Audiologist Position: The Speech & Hearing Center in Valhalla, NY is searching for a dedicated and compassionate part-time Audiologist to join our team of healthcare professionals. As an Audiologist, you will be responsible for evaluating and diagnosing auditory disorders, recommending and providing appropriate treatments, and offering rehabilitative services to patients experiencing hearing loss or other hearing-related issues. About the WIHD's Speech & Hearing Center: The Speech and Hearing Center works in collaboration with Westchester Medical Center, the CI Balancing Center and APS, and is a major resource for audiology in Westchester and the Lower Hudson Valley. We provide the range of diagnostic and rehabilitative services including, diagnostic audiology, electrophysiologic measures (ABR & OAE), auditory processing testing, hearing aids and bone conduction devices. Services are provided to infants, children, and adults, some of whom have neurodevelopmental disabilities. WIHD provides a positive working environment that promotes employee safety, growth and goal attainment. We offer a setting with a desirable work-life balance and flexible schedule. The ideal candidate will possess experience providing the audiology services across the age range. Preference will be given to individuals who have a desire to work with children and/or those with neurodevelopmental disabilities. Some supervision of graduate students may be necessary. Audiologist Qualifications: Master’s or Doctoral degree in Audiology from an accredited institution.NY State licensure or eligibility to obtain licensure as an Audiologist.Certificate of Clinical Competence in Audiology (CCC-A) from the American Speech-Language-Hearing Association (ASHA) or equivalent certification.Strong knowledge of audiological diagnostic procedures, assessment techniques, and treatment options.Proficient in using sophisticated audiological equipment and specialized software for testing and analysis.Excellent communication skills, both verbal and written, with the ability to explain complex audiological concepts to patients of all ages.Empathetic and patient-focused approach to address the emotional and psychological aspects of hearing loss.Detail-oriented with exceptional organizational and time management skills. Benefits: Paid Sick 403 (b) Employee assistance programParental leaveReferral program Why Work at WIHD? Positive, inclusive work environment Flexible schedules for work-life balance Mission-driven organization serving 10,000 individuals annually Equal Opportunity Employer WIHD is committed to fostering a workplace culture that values respect, fairness, and equal opportunity. Employment decisions are based on individual qualifications, experience, and business needs. We comply with all applicable laws and do not discriminate on the basis of race, color, national origin, citizenship status, religion, age, sex, marital status, sexual orientation, gender identity, disability, veteran status, pregnancy, or any other status protected by law. Compensation details: 55 Hourly Wage PId6c7620d4015-38003-40546762

  • East View, NY

  • no content

Global Therapeutic Research Lead - Immunology (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 At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Purpose Leveraging a proven track record of leading at least 3 discovery programs to clinic, The Global Therapeutic Research Lead (GTRL) is a pipeline critical strategic leader responsible for driving Research projects to the clinic. The individual will sit on the Gastroenterology and Inflammation Drug Discovery Unit (GI DDU) Leadership Team. Leader for at least one or more of Takeda’s top priority projects with substantial clinical and commercial potential with a clear accelerated path to the clinic. You will provide mentorship to team members to elevate enterprise thinking and capabilities of our drug discovery talent across the global Research function. As project lead, the GTRL builds a connected view of the project within the Gastroenterology and Inflammation TA strategy and treatment paradigm and can represent all core expertise at depth and align with stakeholders and sponsors across the organization including Research, Clinical Development and Commercial stakeholders and executive level governance committees. The GTRL will be responsible for creating the medicine vision, early asset strategy and managing multiple external partnerships that accelerate delivery of the project. The GTRL will establish smart, fast, and critical path minded practices for groups, including integrating new strategies and competitive industry ways of working. The GTRL will advise on the continuous infusion of new Research projects aligned to strategy to generate a sustainable Research Engine generating a steady flow of high-quality INDs every year. Accountabilities Lead and manage one or more ‘Top 10’ drug discovery projects, overseeing the entire drug discovery process from target identification to preclinical development. (Top 10 projects are well validated targets that are focused on strategically aligned modalities with substantial clinical and commercial potential) Responsible for the articulation and ownership of the project strategy, developed in partnership with internal stakeholders. Contribute to strategy for future portfolio investment, particularly within the Inflammation and Immunology area including advising on which projects should be Top 10 projects. Evaluate and prioritize potential drug candidates based on scientific, medical, and commercial considerations. Represent all core expertise for the project. Partner with Clinical and Translational teams to refine asset strategy. Ensure alignment to the therapeutic area strategy (i.e., Clinical Development). Understand and align with the commercial team for asset commercial value within the TA. Provide guidance and mentorship to global project team members, stimulating enterprise thinking and fostering their professional growth and development. Mentor future and more junior project leads and elevate drug discovery capability across Research. Collaborate with cross-functional teams and partners (e.g., DMPK, Pharmaceutical Sciences) within and outside Takeda to drive project delivery. Pipeline and enterprise impact through effective partnering with multiple internal and external collaborators. Provide strategic, process, and operational leadership for successful Top 10 Project delivery. Foster a culture of innovation and scientific excellence within the matrixed drug discovery team, promoting collaboration, knowledge sharing, and continuous learning. Become a world leading scientific expert in the projects you lead. Oversee the design and execution of experiments, data analysis, and interpretation to enable decision-making and optimize drug discovery efforts. Stay abreast of the latest advancements in drug discovery, emerging technologies, and industry trends, applying this knowledge to enhance drug discovery strategies. Build and maintain relationships with key stakeholders, including academic institutions, research organizations, and industry partners inclusive of serving on joint external governance committees across the globe. Represent Takeda externally for the Gastroenterology and Inflammation Drug Discovery Unit and play a key role in evaluating external opportunities, serving as an effective ambassador for Takeda’s global business development brand. Education & Competencies (Technical and Behavioral): PhD degree in a scientific discipline with 15 years experience , or MS with 21 years experience, or BS with 23 years experience Expected to have at least 10-12 years industry and relevant subject matter expertise within Immunology and Inflammation and at least 10-12 years global management experience, including working effectively with matrix teams. Extensive experience in leading drug discovery teams and managing drug discovery/development projects, preferably in a pharmaceutical or biotechnology setting covering gastroenterology and inflammation. Deep understanding of the drug discovery process, including target identification, hit-to-lead optimization, and preclinical development, anticipating, and removing roadblocks. Proven track record of leading numerous projects, ideally 5 projects, across discovery from target inception to Candidate Nomination or beyond. Played a major role in 3 INDs. Has delivered clinical development assets, must include experience with biologics and preferably across multiple modalities. Excellent and inclusive leadership with the ability to inspire and motivate diverse teams towards achieving ambitious goals. Reputation as a proactive, solutions-oriented leader who engages relevant expertise no matter where it resides. Strong business acumen and understanding of the pharmaceutical industry, including regulatory requirements and commercial considerations with relevant knowledge and expertise for specific modalities. Exceptional communication and presentation skills, with the ability to effectively communicate complex scientific concepts to diverse audiences. Proven ability to build and maintain collaborative relationships with internal and external stakeholders across a matrixed organization. Strong problem-solving and decision-making abilities, with a focus on data-driven decision making. Demonstrated success in building and managing strategic partnerships with academic institutions, research organizations, and industry collaborators. ADDITIONAL INFORMATION The position will be based in Cambridge, MA . This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $212,000.00 - $333,190.00 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

  • Cambridgeport, 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