Terumo BCT, Inc.
Remote Jobs
Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
9 Jobs
Senior Medical Science Liaison EMEA
Terumo BCT, Inc.Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Role Description Acting as a clinical and scientific reference point of the EMEA Medical Affairs team, the (Senior) MSL will be a recognized resource engaged in driving key initiatives in: - Research - Publications - Medical education - Field intelligence between Terumo BCT and the academic medical community The role covers the full Terumo BCT therapeutic portfolio, including: - Cell collections for haematopoietic stem cell transplant and for cell and gene therapy starting materials - Red blood cell exchange - Therapeutic plasma exchange The (Senior) MSL is remote-based in the United Kingdom with responsibilities spanning EMEA and contributions at both regional and global levels, partnering with: - Marketing - Sales - Patient Access - Cross-regional peers on publications, evidence generation, and strategic initiatives They identify unmet medical needs, lead advisory work with international thought leaders and prescribers, and assist the organization in defining scientific and clinical direction. They may also support special projects, including: - Study monitoring - Publication planning and execution - Internal and external education - Identification of gaps for both company-sponsored and investigator research The (Senior) MSL responds to medical, scientific, and clinical information requests regarding high-level troubleshooting and procedure optimization. Qualifications - Medical Doctor (MBBS, MD, or equivalent) preferred, with specialty training in haematology, transfusion medicine, transplantation, apheresis medicine, nephrology, intensive care, or a related clinical discipline. - PhD or PharmD candidates with substantial clinical or apheresis exposure will also be considered. - Senior apheresis or transplant nurses (Registered Nurse with relevant post-registration credentials) with deep cross-portfolio operator experience and a track record of clinical leadership will also be considered. Requirements - Minimum 2 years of combined clinical, nursing, and/or Medical Affairs experience. - Prior role as Medical Director, clinical lead, or lead nurse of an apheresis collection facility, BMT/cell therapy collection or processing unit, or transfusion service is a strong asset. - Hands-on operator experience with the Spectra Optia apheresis platform, or with comparable apheresis devices in routine clinical use, is a strong asset. - Experience contributing to an apheresis, BMT, or transfusion service in an academic, public-hospital, or large transplant-centre setting is highly valued. - Experience supporting or contributing to clinical studies in transplantation, cell therapy, apheresis, or extracorporeal therapies is highly valued. Benefits - Opportunity to work in a dynamic and innovative environment. - Engagement with leading healthcare professionals and organizations. - Professional development and growth opportunities. Company Description Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Category Manager - Indirect (Supply Chain)
Terumo BCT, Inc.Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Role Description As the Category Manager - Indirect (Supply Chain), you will own and evolve end-to-end sourcing strategies across freight and logistics categories, partnering closely with cross-functional stakeholders to drive cost savings, service improvements, and risk-smart supplier relationships. This role offers the opportunity to directly influence the bottom line and shape how supply chain partners support the business. - Executes strategic sourcing strategies, best practices, and initiatives that support improvements in supplier quality, total cost effectiveness, enhanced service levels, improved coordination, delivery, pricing, payment terms, risk compliance and other areas as identified. - Executes indirect procurement category sourcing strategies including the development and execution of RFXs, requirements gathering, development of supplier selection criteria, and supplier negotiations all in collaboration with cross-functional teams. - Executes freight bids for ocean and air using TenderEasy. - Actively seeks ways to streamline business processes; researches and provides information on industry category trends and best practices; and leverages market tools and benchmarks to inform decision making. - Develops negotiation strategies, gains alignment from stakeholders, leads cross-functional, category-based negotiation teams, and implements appropriate supplier risk analysis. Directly negotiates with suppliers. - Uses spend data and business knowledge to identify sourcing projects for individual sub-categories and develops an overall multi-year plan. - Manages category performance by adhering to savings goals, business objectives, and supplier management. - Ability to forge close working relationships throughout the company and use influence and persuasion skills to drive results. - Prepares business cases, including ROI models and effectively presents cost savings proposals to appropriate parties for approval and qualification. - Ensures purchasing compliance with legal, financial, and regulatory requirements (e.g., JSOX). - Advocates and adheres to global procurement policies and procedures. - Supports other indirect spend categories, including Professional Services, IT, and Facilities, to ensure continuity of Strategic Category Management activities when workload balancing is required. Qualifications - Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. - Master’s degree preferred. - Minimum 8 years’ experience in Procurement or category management, preferably in multi-national company and across multiple categories of spend. - Track record in successfully managing all aspects of an indirect supply chain category. - Knowledge of contractual terms and conditions, and provisions specific to supply chain agreements. - Solid knowledge of the logistics industry across all freight modes and supplier base. - Demonstrated sourcing experience developing and leading RFx’s and negotiating with suppliers. - Proficient in sourcing and category management concepts, practices, and procedures. - Proven critical thinking, analytics ability, and business acumen. - Demonstrated comprehensive understanding of business requirements and category ownership having created categories strategies with sound analytics. - Excellent understanding of contracts and contract management. - Track record for achieving savings that impact the bottom line. - Demonstrated ability to manage multiple projects simultaneously and possess the ability to thrive in a continuous improvement environment. Requirements - Strong communication skills and ability to communicate at all levels of the organization. - Ability to move seamlessly from tactical to strategic tasks. - Must have a keen eye for detail, provide insights based on market conditions and trends, optimize value from/with suppliers. - Excellent analytical, leadership, and problem-solving skills. - Ability to develop and execute negotiation strategies. Strong negotiation and contracting skills. - Proactive, results-oriented, reliable, persuasive and an excellent team player. - Proficient in Microsoft Office Suite, with strong Excel skills. - Demonstrated ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence. - Proven ability to positively persuade and influence decision making, at all levels in the organization. - Ability to prioritize well and maintain appropriate balance in a fast-paced, heavy-workload environment. Benefits - Competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs. - Multiple group medical, dental and vision plans. - Robust wellness program. - Life insurance and disability coverages. - Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. - 401(k) plan with a matching contribution. - Vacation and sick time programs for associates.
Global Manager, Survey Science, Analytics & Programming
Terumo BCT, Inc.Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Requisition ID: 34957 At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours. The Global Manager, Survey Science Architecture, Analytics & Programs, as a key member of the Talent & Insights Team of COEs, leads the strategy, execution, and continuous improvement of Terumo Blood and Cell Technologies' employee listening ecosystem. This role is responsible for designing and managing employee surveys and the data architecture to support them, developing advanced sentiment‑analysis models, and transforming employee feedback into actionable insights that strengthen engagement, culture, and organizational performance. The manager partners closely with People Insights & Analytics Team, HRBPs, business leaders, the full Terumo Group of surveying professionals, and cross‑functional stakeholders to ensure employee voice is accurately captured, ethically analyzed, and effectively translated into meaningful action. With this oversight of enterprise-scale data architecture, this Global Manager will leverage a high-performing and innovative end-to-end software/data system. ESSENTIAL DUTIES - Leads the design, deployment, and enhancement of employee surveys, pulse checks, and listening programs across the full talent lifecycle (onboarding, exit, etc.). - Lead the architecture and design of complex, distributed systems with a focus on scalability, security, and performance. - Leads the design and deployment of a new suite of surveys to measure behaviors in support of leadership pathways and other development and training interventions to measure the ROI of talent investments. - Develops and maintains NLP‑based sentiment‑analysis models to evaluate open‑text feedback and identify themes, tone, and emerging risks. - Integrates structured and unstructured data to produce comprehensive insights on employee experience, engagement, and organizational health. - Delivers dashboards, reports, and executive‑ready presentations that clearly communicate trends, risks, and recommended actions. - Delivers modeling to predict risk in sentiment data (eg, likelihood of attrition, etc.). - Partners with HRBPs, and business leaders to interpret results and prioritize interventions that improve employee experience. - Manages, coaches, and develops across the insights team of Data Scientists and Engineers, fostering a culture of analytical rigor, curiosity, and innovation. - Partners with Global Leader Talent & Insights and Legal to ensures data quality, privacy, governance, and compliant and ethical use of employee feedback data. - Evaluates and implements new tools, technologies, and methodologies to advance the employee‑listening strategy. - Uses state-of-the-art tools and technologies to enable full cloud optimization, seamless elasticity and end-to-end automation with considerations for both performance and architecture. - Makes modifications and updates to existing data pipelines as necessary. - Critically reviews current and future data structures with an eye towards simplicity, performance, and scalability. - Define and enforce architectural standards, secure development practices, and DevOps principles across the People Data team. - Drive innovation by evaluating and implementing emerging technologies, tools, and methodologies. - Lead architectural reviews, technical design sessions, and cross-functional planning initiatives. - Ensure traceability of requirements through design, implementation, and validation phases. - Help to foster the data-driven and technology-savvy culture across our business by serving as a tech evangelist and encourage forward thinking development. - Participate in SAAS technology evaluations and/or collaborate with other areas of business on technology strategy—and with an enterprise mindset. - Project management for survey deployment as required. MINIMUM QUALIFICATION REQUIREMENTS - Ten (10) + years of experience in analytics, data science, people analytics, or a related field. - Demonstrated success in leading secure software architecture initiatives. - Hands‑on experience with NLP, sentiment analysis, and text‑analytics methodologies. - Proficiency with Python or R, as well as business intelligence and data‑visualization tools. - Experience designing, administering, or analyzing employee surveys or similar research instruments. - Demonstrated ability to translate complex analytics into clear insights for senior stakeholders. Education Bachelor’s degree in Computer Science, Software Engineering and/or Statistics and/or related field, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Master’s preferred. Experience - Experience with Python, Java, C++, Scala or similar object-oriented programming languages and using software automation/CICD tools. - Experience with Tableau, R Shiny, Microsoft BI and/or modern data visualization technologies. - Experience with Qualtrics, Glint, and other Employee Sentiment/Survey Softwares. - Experience with LLM‑based text analysis or modern embedding models. - Familiarity with i/o psychology, psychometrics, experimental design, or causal inference. Preferred Qualifications - Prior leadership or team‑management experience. - Knowledge of organizational psychology, employee engagement frameworks, or EX measurements. - Exposure to/ Experience with Alteryx Server a plus. - Exposure to/ experience with Lean Six Sigma preferred. - Project Management experience and/or certification. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. LOCATION Remote - Ability to work concurrently with Americas, EMEA, and APAC time zones. PHYSICAL REQUIREMENTS - Typical Office Environment requirements, may include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. - The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Target Pay Range: $147,300.00 to $184,200.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base: 15.0% We anticipate this requisition will be open for a minimum of five days, from April 9, 2026. We encourage your prompt application. At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind. - Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. - In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue. - We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. - We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. - Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. - Respect – Appreciative of others - Integrity – Guided by our mission - Care – Empathetic to patients - Quality – Committed to excellence - Creativity – Striving for innovation - We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
Senior Manager, Supply Chain Fulfillment
Terumo BCT, Inc.Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Role Description We’re seeking a Senior Manager, Supply Chain & Fulfillment Leader for North America to own end‑to‑end logistics, warehousing, and S&OP execution for a critical region that supports long‑term business growth. This highly visible role sits on both regional and global leadership teams and drives strategy across network design, inventory planning, trade compliance, 3PL partnerships, and operational excellence—balancing service, cost, and scalability over a 5‑year horizon. You’ll collaborate closely with Sales, Marketing, Quality, Regulatory, and Operations while leading a team through transformation initiatives, advanced planning systems, and continuous improvement. Ideal candidates bring deep global supply chain expertise, strong people leadership, and a passion for building high‑performing, standardized, and customer‑focused supply chains in a growing, multinational environment. Qualifications - Bachelor’s degree or equivalent education and experience. - Minimum 10 years’ experience in related fields, with recent years in progressive management positions. - Experience owning/facilitating S&OP process at a regional/global level. - Advanced Planning System’s (Demand & Supply) Implementation experience. - ERP system expertise and Logistics/Warehousing – SAP experience. - Proven leadership and managerial abilities. - Demonstrated management experience with warehouse operations and transportation modes. - Experience with 3PL and 4PL/LLP suppliers. - Subject matter expertise in inventory control methods. - Understanding of accounting and finance. - Ability to manage projects while meeting budget and schedule constraints. - Successful experience working proactively in a global environment. - Knowledge and use of relevant PC software applications. - Demonstrated ability to communicate effectively both verbally and in writing. Requirements - Active member of the Commercial Regional Leadership Team and Global Supply Chain Fulfillment Leadership Team. - Manages and provides leadership for the functional group’s development, direction, and effectiveness. - Develops and executes the regional network strategy optimizing service and cost. - Provides expertise and responsibility for regions’ import/export functions and compliance. - Manages operating expenses of assigned departments and logistics services spend. - Manages freight payment audit company for business within the region. - Develops and maintains successful relationships with 3rd party warehouse and logistics suppliers. - Measures, monitors, and reports monthly KPIs. - Collaborates with Marketing, Sales, Regulatory, Quality, and Operations. - Ensures sufficient product flow to customers in assigned regions. - Drives 24m month demand plan at code country level @ 80%+ Accuracy. - Secures and manages inbound supply from both internal and external suppliers. - Manages inventory obsolescence risk and transitions for new product introductions. - Supports Order-to-cash (OTC) process ensuring customer satisfaction. - Manages customer complaints related to deliveries and logistics. - Implements solutions for continuous improvements. - Owns Supply Chain Strategy for Region (5-year horizon). - Active contributor to Global Supply Chain Strategy. Benefits - Competitive total reward offerings including compensation, benefits, and recognition programs. - Multiple group medical, dental, and vision plans. - Robust wellness program. - Life insurance and disability coverages. - Variety of voluntary programs such as group accident, hospital indemnity, and critical illness insurance. - 401(k) plan with matching contribution. - Vacation and sick time programs for associates.
Medical Education Lead
Terumo BCT, Inc.Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Requisition ID: 34817 At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours. The Medical Education Lead (MEL) will support the delivery and embedding of medical education in North America in order to develop the clinical skills, knowledge, confidence and competencies of the internal team and the health care professional’s community with the aim of increasing therapy awareness & adoption. The MEL will be a business partner who will engage in identifying and overcoming unmet medical needs especially related to apheresis and cell therapies. The MEL will act both internally and externally to develop therapy adoption programs together with North America (NA) thought leaders and prescribers. The MEL may be called on to support, participate and/or drive special projects, such as clinical trials, internal and external education and medical congresses. The MEL will respond to medical, scientific & clinical information requests with regards to high-level troubleshooting and procedure optimization. DUTIES AND RESPONSIBILITIES - Develops and maintains professional scientific relationships in areas critical to Terumo Blood and Cell Technologies (TBCT) with thought leaders and health care professional in key medical or blood centers, with medical professional associations and patient advocacy groups - Works with the sales and marketing team to build knowledge, confidence and competence to drive clinical excellence and help to achieve unmet medical needs in the field of Apheresis - Serves as a primary Medical Affairs contact involved with clinical/scientific information exchanges. These exchanges may be verbal, written or electronic inquiries from healthcare professionals. - Identifies opportunities and conducts formal presentations to essential groups as requested by medical and technical healthcare professionals, including key accounts, hospital therapeutic committee members in accordance with company policies, applicable laws, regulatory guidelines, and ethical standards. - Maintains expert knowledge and understanding of clinical, scientific, and technical information in areas critical to TBCT through collaboration with the global medical affairs organization, attending conferences and networking with experts. - Support the commercialization team and global product marketing where appropriate, providing input as needed in product innovation and unmet medical needs. - Active participation in developing tools, resources e.g. training material. - Attends & provides coverage at national & regional medical education venues (congresses, conferences, symposia) and brings back medical insights to key internal stakeholders for accurate planning. - Responds to and tracking medical information requests from healthcare professionals and decision makers with accurate, unbiased, balanced and timely answers. - May lead and/or coordinate special projects as it relates to building scientific & medical competencies within the organization, such as internal training of sales & marketing, scientific symposium program, presentation and slide kit development. MINIMUM QUALIFICATION REQUIREMENTS Education - Registered Nurse (RN) credentials required. - Master’s or bachelor’s Degree strongly preferred. Experience - Minimum 6+ years’ experience in apheresis, blood product management, blood transfusion or blood banking. - Apheresis technology experience is strongly preferred. - Previous experience with genetic hematological disorders such as sickle cell disease will be a plus. Skills - Strong interpersonal, influencing, and negotiation skills with different types of internal and external stakeholders. - Team player, patient and customer-focused, problem solver with clear focus on end-results. - Ability to work autonomously and independently with time management skills to effectively manage field-based responsibilities. - Ability to work in a matrix structure, i.e. maintains strong working relationships with various other departments, such as Scientific & Clinical Affairs, Regulatory Affairs, Legal, Global & Regional Marketing and Sales. - Able to build trust and credibility with healthcare professionals, internal experts, and cross‑functional partners. - Excellent in written and oral communication skills in English. Any additional language will be a plus. Certificates, Licenses, Registrations - Registered Nurse (RN) credentials required. - Certification in Apheresis or other professional credentials and/or certifications preferred. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. LOCATION Lakewood, Colorado or Remote TRAVEL Domestic travel required up to 20-30%. PHYSICAL REQUIREMENTS - Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. - The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Target Pay Range: $120,600.00 to $150,800.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base: 10.0% At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind. - Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. - In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue. - We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. - We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. - Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. - Respect – Appreciative of others - Integrity – Guided by our mission - Care – Empathetic to patients - Quality – Committed to excellence - Creativity – Striving for innovation - We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
Category Specialist - Direct Procurement
Terumo BCT, Inc.Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Requisition ID: 34559 At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours. In this high‑impact role as a Category Specialist, you’ll play a key part in shaping our global procurement strategy by optimizing category spend, strengthening supplier performance, and driving cost‑effective purchasing practices across the organization. Acting as a strategic extension of the Category Manager, you’ll lead spend analysis, support global sourcing initiatives, and help build supplier relationships that ensure optimal inventory levels, supply assurance, quality, and delivery. This is an excellent opportunity for someone who thrives in a data‑driven, fast‑paced environment and wants to influence category strategy on a global scale while making a measurable difference in operational efficiency and total cost reduction. ESSENTIAL DUTIES - Identify and execute alternate sourcing, supplier consolidation and localization to maximize pricing leverage, and cycle time improvements. - Drive and manage enhanced margin through improved material cost savings. - Drive category performance improvement to stated goals: Lead time improvements, Minimum Order Quantity improvements, Localization or Vendor Managed Inventory opportunities, Payment Terms, Incoming Quality, decrease inventory levels and increase inventory turns. - Drive supplier performance improvements to stated goals. - Understand Internal and Supplier Manufacturing Processes to improve cost and reduce waste. - Prepare Business Cases, including ROI models, and effectively present Cost Savings and Risk Mitigation proposals to appropriate parties for approval and qualification. - Develop and execute RFQ’s, cost models, and estimates for initial project resourcing needs. - Negotiate business T & C's relating to: payment terms, delivery terms, inventory strategies, lead times, price improvement, supply assurance and other strategic issues with key suppliers. - Provide rigorous analysis of spend data and market trends/dynamics by site, supplier and/or category to prioritize and launch sourcing initiatives. - Monitor current category market conditions, technology roadmaps and identify supply/demand challenges. Develop, implement and communicate tactical and strategic category plans internally as appropriate. - Accountable for working closely with customer-facing teams, operation teams, and R&D and supplier engineering teams to ensure that the supplier strategy supports product and customer needs. - Manage commodities/materials/spend to achieve the annual performance metrics applicable to Supply Chain – planning, logistics, warehousing, and procurement. - In conjunction with operations leadership, direct supervisor, and peer leads in other regions, construct category and supplier strategies by region that support the manufacturing technologies currently produced in each region. - Ensure that all supplier and sourcing strategies support the “best total landed cost” objective of the business, including costs of inventory ownership, transport, customs, duties and lead-time. - Ensure that product compliance of suppliers meets all existing and future corporate social responsibility and product compliance requirements. Conduct periodic reviews of suppliers to ensure such compliance. - Prepare and provide documentation of such compliance as is required by corporate and other regulatory reporting agencies. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience - Minimum 4 years’ experience in Sourcing/Procurement/Supply Chain or Manufacturing/Operations or R&D in a large, multi-national, medical device company. - Operational Excellence (Lean, Six Sigma, or Similar) experience. - Proven success in managing suppliers or in managing complex manufacturing processes. - This position can be fulfilled as a learning experience or career broadening role for associates with experiences in fields other than those listed. Skills - Knowledge and use of relevant PC software applications and skills to use them effectively. - Proven track record of driving positive results. - Demonstrated ability to communicate effectively both verbally and in writing. - Demonstrated ability to drive continuous improvement initiatives by leveraging Lean, Six Sigma, and data analytics to optimize processes, reduce waste, and enhance cross-functional efficiency. - Highly self-motivated team player who can work effectively with management, business unit personnel, and other stakeholders. - Demonstrated ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence. - Effective project management skills. - Proven ability to positively persuade and influence decision making, at all levels in the organization. - Person of true convictions; Willing to stand up for those convictions; Able to communicate, reinforce and coach/counsel others on those convictions; Unafraid of change / improvement. - Interpersonal skills that could be described as “firm but fair”; Objective yet compassionate in evaluating performance; Can connect all people of the organization to the mission and goals of the organization. - Ability to prioritize very well and maintain appropriate balance in a fast-paced, heavy-workload environment. - Sound problem-solving skills in both functional areas of operations and interpersonal relationship management. Certificates, Licenses, Registrations APICS and/or CPSM certification or willingness to work towards same. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. LOCATION Lakewood, Colorado or Remote. TRAVEL Willing to Travel regional and globally as required 10 - 25%. PHYSICAL REQUIREMENTS - Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. - The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Target Pay Range: $104,600.00 to $130,800.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base: 7.0% We anticipate this requisition will be open for a minimum of five days, from March 30, 2026. We encourage your prompt application. At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind. - Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. - In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue. - We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. - We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. - Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. - Respect – Appreciative of others - Integrity – Guided by our mission - Care – Empathetic to patients - Quality – Committed to excellence - Creativity – Striving for innovation - We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
Medical Education Lead
Terumo BCT, Inc.Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Requisition ID: 34817 At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours. The Medical Education Lead (MEL) will support the delivery and embedding of medical education in North America in order to develop the clinical skills, knowledge, confidence and competencies of the internal team and the health care professional’s community with the aim of increasing therapy awareness & adoption. The MEL will be a business partner who will engage in identifying and overcoming unmet medical needs especially related to apheresis and cell therapies. The MEL will act both internally and externally to develop therapy adoption programs together with North America (NA) thought leaders and prescribers. The MEL may be called on to support, participate and/or drive special projects, such as clinical trials, internal and external education and medical congresses. The MEL will respond to medical, scientific & clinical information requests with regards to high-level troubleshooting and procedure optimization. DUTIES AND RESPONSIBILITIES - Develops and maintains professional scientific relationships in areas critical to Terumo Blood and Cell Technologies (TBCT) with thought leaders and health care professional in key medical or blood centers, with medical professional associations and patient advocacy groups - Works with the sales and marketing team to build knowledge, confidence and competence to drive clinical excellence and help to achieve unmet medical needs in the field of Apheresis - Serves as a primary Medical Affairs contact involved with clinical/scientific information exchanges. These exchanges may be verbal, written or electronic inquiries from healthcare professionals. - Identifies opportunities and conducts formal presentations to essential groups as requested by medical and technical healthcare professionals, including key accounts, hospital therapeutic committee members in accordance with company policies, applicable laws, regulatory guidelines, and ethical standards. - Maintains expert knowledge and understanding of clinical, scientific, and technical information in areas critical to TBCT through collaboration with the global medical affairs organization, attending conferences and networking with experts. - Support the commercialization team and global product marketing where appropriate, providing input as needed in product innovation and unmet medical needs. - Active participation in developing tools, resources e.g. training material. - Attends & provides coverage at national & regional medical education venues (congresses, conferences, symposia) and brings back medical insights to key internal stakeholders for accurate planning. - Responds to and tracking medical information requests from healthcare professionals and decision makers with accurate, unbiased, balanced and timely answers. - May lead and/or coordinate special projects as it relates to building scientific & medical competencies within the organization, such as internal training of sales & marketing, scientific symposium program, presentation and slide kit development. MINIMUM QUALIFICATION REQUIREMENTS Education - Registered Nurse (RN) credentials required. - Master’s or bachelor’s Degree strongly preferred. Experience - Minimum 6+ years’ experience in apheresis, blood product management, blood transfusion or blood banking. - Apheresis technology experience is strongly preferred. - Previous experience with genetic hematological disorders such as sickle cell disease will be a plus. Skills - Strong interpersonal, influencing, and negotiation skills with different types of internal and external stakeholders. - Team player, patient and customer-focused, problem solver with clear focus on end-results. - Ability to work autonomously and independently with time management skills to effectively manage field-based responsibilities. - Ability to work in a matrix structure, i.e. maintains strong working relationships with various other departments, such as Scientific & Clinical Affairs, Regulatory Affairs, Legal, Global & Regional Marketing and Sales. - Able to build trust and credibility with healthcare professionals, internal experts, and cross‑functional partners. - Excellent in written and oral communication skills in English. Any additional language will be a plus. Certificates, Licenses, Registrations - Registered Nurse (RN) credentials required. - Certification in Apheresis or other professional credentials and/or certifications preferred. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. LOCATION Lakewood, Colorado or Remote TRAVEL Domestic travel required up to 20-30%. PHYSICAL REQUIREMENTS - Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. - The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Target Pay Range: $120,600.00 to $150,800.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base: 10.0% At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind. - Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. - In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue. - We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. - We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. - Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. - Respect – Appreciative of others - Integrity – Guided by our mission - Care – Empathetic to patients - Quality – Committed to excellence - Creativity – Striving for innovation - We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
Senior Project Manager, Digital Manufacturing Transformation
Terumo BCT, Inc.Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Requisition ID: 34819 At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours. As a Senior Project Manager, you'll lead a high‑impact global initiative to implement our Manufacturing Execution System (MES) across multiple factories worldwide. In this role, you’ll drive a major digital transformation, modernizing operations, connecting systems, and enabling real‑time visibility that will elevate how our plants run and how our teams work. You’ll partner with leaders across engineering, manufacturing, and IT to shape strategy, streamline processes, and deliver a unified MES platform that becomes the digital backbone of our global production network. This role drives enterprise adoption of digital capabilities (e.g., MES, IIoT/automation, workflow digitization, data platforms/analytics, and enterprise integrations) to deliver measurable value, strengthen compliance, and elevate operational excellence across multiple sites and functions. If you’re excited by complex international programs, cutting‑edge manufacturing technology, and the chance to influence enterprise‑level change, this is the opportunity to make a lasting mark. ESSENTIAL DUTIES - Lead multiple large‑scale, multi‑site digital transformation projects, ensuring integration, rigorous planning/execution, process compliance, and prioritization aligned to strategy. - Evaluate and manage inter‑relationships between projects and functional goals; ensure initiatives are executed within organizational capacity. - Track organization‑wide metrics on project delivery and value/ROI; present insights to leadership to support decision‑making. - Translate business outcomes into multi‑site digital roadmaps spanning MES, IIoT/automation, plant connectivity, data/analytics, and integration layers. - Orchestrate the end‑to‑end lifecycle: discovery and requirements, architecture/design, implementation, verification/validation (IQ/OQ/PQ where applicable), deployment, hypercare, and sustainment in regulated operations. - Establish KPIs and benefits‑realization plans; ensure business case targets are achieved and sustained post‑go‑live. - Create and execute scalable project support plans; resolve and/or escalate issues in a timely manner. - Lead cross‑functional dependency, risk, and decision forums; maintain auditable project documentation and governance records. - Deliver clear, informative, and well‑organized project communications and executive‑level presentations on strategy, status, risks, and outcomes. - Influence senior leaders and align global stakeholders across Operations, Engineering, Quality, IT, and Supply Chain to accelerate adoption and standardization. - Coordinate internal and external resources to ensure proper assignment and alignment with the project plan. - Partner with HR and site leadership to design training, communications, and organizational readiness plans; ensure handoffs to sustaining teams with complete SOPs, knowledge assets, and support models. - Drive standardization of digital processes, data definitions, and documentation across sites. - Ensure project execution complies with internal QMS and applicable regulatory frameworks (e.g., GxP/ISO) through risk‑based validation strategies, traceability (URS → FDS → IQ/OQ/PQ → UAT), audit readiness, and robust documentation. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree required; MBA desirable or equivalent education/experience sufficient to perform essential functions. Experience - Minimum 6 years managing large/complex projects, including full accountability for deliverables and cross‑functional team performance. - Minimum 3 years of success delivering digital transformation in manufacturing/industrial or regulated environments (e.g., MES, IIoT/automation, analytics, integrations, workflow digitization). - Proven ability to translate strategy into executable roadmaps and manage benefits realization at scale. Skills - Ability to manage and successfully execute high‑impact digital transformation projects, owning objectives, budgets, business cases, WBS, schedules, risks, and critical milestones. - Strong capability in coordinating resources across multiple workstreams, coaching teams, and driving accountability to outcomes. - Exceptional communication and executive presence; able to simplify complex topics for non‑technical audiences and drive decision quality under ambiguity. - Strong financial acumen (budgeting, forecasting, ROI analysis) and mastery of project governance/PMO standards. Certificates, Licenses, Registrations PMP or equivalent certification preferred. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. LOCATION Lakewood, Colorado or Remote TRAVEL Travel required (up to 30%) PHYSICAL REQUIREMENTS - Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. - The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Target Pay Range: $115,100.00 to $143,900.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base: 10.0% At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind. - Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. - In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue. - We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. - We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. - Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. - Respect – Appreciative of others - Integrity – Guided by our mission - Care – Empathetic to patients - Quality – Committed to excellence - Creativity – Striving for innovation - We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
Global Clinical Regulatory Support Specialist
Terumo BCT, Inc.Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.
Requisition ID:  34773     At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.   We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.   With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.   The Global Clinical Regulatory Specialist is responsible for writing Clinical Evaluation Plans & Reports (CEPs, CERs) and Post-market clinical follow up (PMCF) Plans & Reports for Terumo Blood and Cell Technologies (TBCT) products. The Specialist relies on product labeling, preclinical data, clinical data, published literature, risk management documentation, complaints, post market surveillance, and adverse event reporting to create the documentation. The Specialist will be responsible for data collection, data appraisal, data extraction from the available safety and performance data set. The Specialist will be responsible for the  final compilation/authoring of new and scheduled Systematic Literature Reviews (SLRs), Clinical Evaluation and PMCF doumentation for a variety of devices.   ESSENTIAL DUTIES AND RESPONSIBILITIES - Lead the development of CERs and PMCF by bringing together various stakeholders (eg, Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, Clinical Research Scientists, Pre-clinical Research Scientists, Marketing, Product Lifecycle Engineers, and information specialists [e.g. TBCT librarians]) to identify relevant documentation needed for the SLR and to import into the content of CERs. - Collaborate with the information specialist to conduct systematic literature searches on Terumo BCT products and product families, and identified equivalent, comparator and competitor products. - Review and Appraise the published literature to identify articles applicable to the safety and performance of TBCT products. - Cross-lane collaboration to 1) understand regulatory submissions and priorities, 2) develop literature search strategy 3) Facilitate the SLR and produce the SLR report 4) compile necessary inputs (eg risk management, labeling, postmarket surveillance, verfication reports, validation reports), 5) compile  preclinical data, including verification summary report and validation summary report 6) complie clinical data, including Clinical Investigation Protocols and Clinical Study Reports, for Clinical Investigations. - Author new and scheduled SLRs, CER and PMCF documents for TBCT products, according to business and research priorities. - Manage document reviews, reconcile major review comments and concerns, and manage finalization and approval of the SLR, Clinical Evaluation and PMCF documents. - Collaborate with relevant cross-functional teams to provide input on risk management deliverables, clinical research and literature evidence for product development process needs. - Manage ongoing proactive literature review to identify complaints or safety concerns for a specific product portfolio. - Represent functional group for audits and contribute to global regulatory body submissions or responses. - Remain current in Clinical Evaluation and PMCF regulatory requirements for all applicable countries. - Develop policies/procedures as needed. - Work with contractor(s) to guide development and update of documents, as needed. - Dissemate findings quantified in the update process of Clinical Evaluation and proactive literature reviews. - Develops Systematic Literative Review, Clinical Evaluation and PMCF logistics such as deliverables, timelines and draft reviews. - This position is required to assure compliance of Company operations to all applicable laws, regulations, and standards, good business practices and company documented procedures.   MINIMUM QUALIFICATION REQUIREMENTS Education - A graduate degree (e.g. MS, PhD) in a scientific, biological or medical science discipline and/or regulatory discipline or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.   Experience - Qualified individuals have five (5) years' experience  and should possess knowledge of the following: research methodology; information management; experience with relevant databases; regulatory requirements; training and experience in medical writing; systematic review;  and clinical data appraisal. - Clinical evaluation reporting experience in academic or the medical device/pharmaceutical industry in clinical, or regulatory roles, or device development experience in medical device/pharmaceutical industry. - The Specialist has experience and understanding of clinical research and regulatory guidelines.     Skills - Possess leadership skills. - Possess interpersonal savvy and ability to develop and maintain crucial interdepartmental relationships. - Work effectively alone and with minimal direction or supervision as well as function effectively as a part of a multi-disciplinary team. - Effectively prioritize and progress multiple simultaneous priority projects and demands. - Able to present concepts and information to a wide variety of disciplines and functions related to CER content. - Develop and implement global policies and procedures. - Analyze information coming from multiple internal an external sources. - Solid understanding of scientific/clinical research methodology. - In-depth knowledge of regulatory process (CE Marking, IDE, PMA, 510(k), post-market/post approval), GCP procedures, and legal compliance for pharmaceutical and/or medical device industry. - Demonstrated ability to utilize a variety of software programs (e.g., Microsoft Office, Excel, Word, PowerPoint). - Demonstrated writing capability and critique of clinical and regulatory documentation. - Program/project management skills for effective project execution and management. - Familiarity with or ability to quickly learn general writing and presentation software.     LOCATION Lakewood, Colorado or Remote - Open to candidates willing to relocate to the area.   PHYSICAL REQUIREMENTS - Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. - The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.   - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.     Target Pay Range:  $101,900.00 to $127,400.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base:  7.0%   At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.   - Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. - In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue. - We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. - We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. - Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. - Respect – Appreciative of others - Integrity – Guided by our mission - Care – Empathetic to patients - Quality – Committed to excellence - Creativity – Striving for innovation - We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.   We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.   Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.