7 open positions available
Lead and manage regional regulatory activities, develop regulatory strategies, and ensure compliance with global requirements. | Requires 10+ years in biotech/pharma regulatory affairs, with a scientific degree and knowledge of FDA/ICH regulations. | Job Description: • Manage and train/mentor junior staff • Lead the development and implementation of regulatory strategy • Manage regional regulatory activities as part of a Global Regulatory Team • Plan, coordinate, author, and prepare regulatory submissions • Ensure compliance with global regulatory requirements Requirements: • Bachelor’s degree in a related field required • 10+ years of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs • Master’s degree preferred (preferably in a scientific discipline) • Strong verbal and written communication skills • Advanced understanding of medical terminology, and FDA and ICH regulations/guidance documents Benefits: • merit-based salary increases • short incentive plan participation • eligibility for 401(k) plan • medical, dental, and vision insurances • life and disability insurances • leaves provided in line with work state • flexible paid time off • 11 paid holidays • additional time off for shut-down period during the last week of December • 80 hours of paid sick time upon hire and each year thereafter
Lead the design, configuration, integration, and validation of SAP S/4HANA solutions across pharmaceutical supply chain processes, ensuring compliance and effective system integration. | Extensive experience (8+ years) in SAP ERP, with deep expertise in SAP S/4HANA modules relevant to supply chain and manufacturing, and proven experience in pharmaceutical industry GxP compliance and validation. | Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Manager, Enterprise Applications - Tech Ops (SAP) Job Overview We are seeking a highly motivated and experienced SAP S/4HANA Solution and Functional Manager to manage and drive our digital transformation across critical Technical Operations and Supply Chain processes. This pivotal role will focus on ensuring the seamless, compliant, and integrated operation of our core business processes—from Production to Delivery, Intercompany, Logistics, and Customer and Patient facing Integration scenarios. The successful candidate will own the end-to-end design, configuration, integration, and validation of SAP S/4HANA solutions, ensuring strict adherence to global pharmaceutical GxP and regulatory requirements. This is a challenging and rewarding opportunity for a seasoned SAP professional to make a significant impact on our operational efficiency, effectiveness, and audit readiness. Job Duties and Responsibilities 1. Production-to-Delivery & Core Functional Leadership Process Ownership: Lead the analysis, design, configuration, and implementation of SAP S/4HANA solutions across the entire value chain, focusing on: Order-to-Shipment (SD/LE): Sales Order processing, intercompany transactions, delivery processing, Billing and Invoicing. Logistics Execution (LE): Shipment planning, transportation, and trade compliance. Production Planning (PP): Integration of Production Orders with material planning and execution. Extended Warehouse Management (EWM): Management of inventory and warehouse operations related to finished goods and raw materials. Module Configuration: Expertly configure and customize SAP S/4HANA modules (SD, LE, PP, EWM) to align highly complex pharmaceutical business processes, including batch management, quality inspection, and serialization requirements. Functional Design: Develop detailed functional designs, configuration documents, and technical specifications for enhancements, custom developments (e.g., RICEF objects), and complex business scenarios. 2. Enterprise Integration Management Salesforce Integration: Design, implement, and maintain robust, compliant, and scalable integrations between SAP S/4HANA (Master Data and Transaction Data) and the Salesforce platform, ensuring accurate data flow for customer orders and financial reconciliation. CGTO Integration: Strategically design and implement integration points between SAP S/4HANA and Cell and Gene Therapy Operations (CGTO) systems, ensuring full traceability and compliant transfer of data for patient-specific manufacturing and logistics processes. System Architecture: Collaborate with Enterprise Architects to ensure solution design adheres to best practices for data integrity, performance, and security across the integrated landscape. 3. GxP Compliance, Validation & Quality Assurance Validation Leadership: Actively participate in, and often lead, validation activities, including the generation of validation protocols (IQ, OQ, PQ) and execution of system validation and User Acceptance Testing (UAT) scripts. Regulatory Compliance: Ensure all SAP S/4HANA configurations, custom code, and documentation strictly comply with pharmaceutical industry standards, including GxP (GMP, GDP) requirements, 21 CFR Part 11, and global data privacy regulations. Testing Oversight: Own and drive the full testing lifecycle: Participate in Unit Testing (UT) and System Integration Testing (SIT). Lead and document User Acceptance Testing (UAT) with business stakeholders. Collaborate with the testing team to identify, manage, and resolve defects through a formal change control process. 4. Leadership, Management & Support Project Execution: Manage and prioritize project timelines, budgets, and resources for S/4HANA rollouts and enhancement projects. Post-Implementation Support: Provide critical Tier 2/3 operational support, including troubleshooting, complex issue resolution, and root cause analysis for production incidents. Training & Documentation: Develop and provide ongoing, role-based training and SOPs (Standard Operating Procedures) for end-users on new SAP functionalities to ensure high adoption and compliance. Key Core Competencies SAP S/4HANA Solution and Functional Manager to core business processes—from Production to Delivery, Intercompany, Logistics, and Customer and Patient facing Integration scenarios. End-to-end design, configuration, integration, and validation of SAP S/4HANA solutions, ensuring strict adherence to global pharmaceutical GxP and regulatory requirements. Education and Experience Required Experience & Skills 8+ years of progressive experience in implementing and configuring SAP ERP systems, with a minimum of 5 years specifically on SAP S/4HANA. Deep functional expertise in SAP modules relevant to Supply Chain and Tech Ops, including SD (Sales & Distribution), LE (Logistics Execution), PP (Production Planning), and EWM (Extended/Warehouse Management). Familiarity with FI/CO (AR) integration is essential. Proven experience within the Pharmaceutical or Biotechnology industry, demonstrating an excellent understanding of GxP, validation (CSV), and regulatory compliance requirements. Strong background in designing and implementing integrations between SAP and external systems (middleware experience preferred, e.g., SAP CPI, PI/PO). Demonstrated ability to lead and motivate functional and technical teams during complex project life cycles. Exceptional analytical, problem-solving, and communication skills, with the ability to translate complex technical requirements into business-friendly language. Preferred (Desired) Skills Direct experience with Salesforce (or other CRM) integration with SAP for Order-to-Cash processes. Direct experience with Cell and Gene Therapy Operations (CGTO) business processes and integration/data requirements. Certification in SAP S/4HANA (specifically Sales/Supply Chain or Manufacturing). Experience with Agile methodologies (Scrum/Kanban). Experience with SAP Business Technology Platform (BTP) applications or Fiori application development. Cloud experience (e.g., RISE, AWS, Azure) related to SAP hosting or integration. The base salary range for this role is $125,600 to $157,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars. Our Mission To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide Our Vision For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas
Lead and manage GxP-critical SAP system documentation, change control, validation, and compliance activities in a regulated pharmaceutical environment. | Requires 5+ years supporting SAP ERP systems, GxP validation experience, and deep SAP module knowledge, which are not aligned with your healthcare policy and administration background. | Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Senior System Analyst, Enterprise Apps, Tech Ops Job Overview We are seeking an experienced and meticulous Senior System Analyst to serve as the primary expert responsible for the governance, documentation, and compliance lifecycle of our GxP-critical SAP Enterprise Applications. This role is central to maintaining our validated state by rigorously managing Change Control, Test Execution, and all required GxP documentation (SOPs, Work Instructions, Protocols) for SAP S/4HANA systems used across Manufacturing, Quality, and Supply Chain. Job Duties and Responsibilities 1. GxP Documentation & Quality System Management Documentation Authoring: Lead the development, review, and maintenance of all GxP-critical documentation, including Standard Operating Procedures (SOPs), Work Instructions (WIs), and associated policy documents for SAP system usage and support. Requirements & Design: Collaborate directly with business users to finalize User Requirements Specifications (URS) and translate them into detailed Functional Specifications (FS) for system changes, ensuring traceability to testing protocols. Audit Support: Maintain the document repository to ensure all validation and change records are complete, accurate, and readily available for internal and external regulatory inspections (e.g., FDA, EMA). 2. Change Control & Execution Leadership Change Management Process: Lead the change control process for all SAP system modifications (implementations, upgrades, config changes, system enhancements) from inception to deployment. Impact Assessment: Conduct thorough Impact Assessments for all proposed GxP system changes to identify potential risks to the validated state, data integrity, and regulatory compliance. Change Control Board (CCB): Participate the Change Control Board (CCB) process, facilitating meetings, documenting decisions, and ensuring necessary functional and QA approvals are obtained before implementation. Execution & Coordination: Assist with the generation of change requests, lead the actual Change Execution in the system, and coordinate technical and functional teams to ensure timely and compliant implementation. 3. Testing, Validation & Compliance Execution Test Documentation: Prepare and maintain comprehensive Test Documentation, including creation of detailed test scripts (IQ/OQ/PQ) and traceability matrices, ensuring alignment with URS and FS. Test Execution: Lead and perform the execution of validation testing (IQ, OQ, PQ) and coordinate integration and system-level tests, ensuring all results and deviations are properly documented and resolved. Compliance Expertise: Support GxP applications and systems, ensuring adherence to regulatory standards such as GAMP 5, 21 CFR Part 11 (Electronic Records and Signatures), Computer System Validation (CSV) principles, and evolving guidance from regulatory bodies. 4. Collaboration & SAP Functional Support Stakeholder Liaison: Act as the primary liaison between IT functional teams, Quality Assurance (QA), and key business process owners (Manufacturing, Quality, Supply Chain) to facilitate smooth change implementation. Configuration Support: Provide functional support by assisting in the configuration and customization of SAP S/4HANA modules relevant to pharmaceutical operations (e.g., QM, PP, MM, SD). System Improvement: Propose alternate processes and procedures to streamline IT operations, increase efficiency, and ensure systems are optimized while remaining compliant. Key Core Competencies The ideal candidate possesses deep SAP functional knowledge, exceptional attention to detail, and a proven ability to collaborate with Quality Assurance (QA) and business stakeholders to ensure every system modification adheres to global pharmaceutical regulations. Provide end‑to‑end ownership of GxP‑regulated enterprise applications supporting Quality (QMS, Document Control, Training, Deviation/CAPA, Supplier Quality, Batch Release, etc.). Veeva Quality & T&Q Application Ownership Lead test strategy, planning, and execution for SAP releases, enhancements, and integrated applications. Oversee test documentation, scripts, traceability, and defect management to ensure completeness and GxP compliance. Ensure alignment with CSV (Computer System Validation) and cGMP expectations when testing impacts GxP processes. Partner with SAP functional leads and business process owners to ensure risk‑based testing coverage. Lead development, review, and approval of validation documentation (URS, FS, DS, IQ/OQ/PQ, test scripts). Maintain stringent controls over protocol execution and documentation integrity. Establish governance processes for change control, periodic review, system monitoring, and release readiness. Ensure electronic records and signatures comply with regulatory requirements. Proactively identify system risks, gaps, and compliance exposures; drive mitigation actions. Collaborate closely with Quality, Manufacturing, Supply Chain, Regulatory, and IT leaders. Translate business needs into system requirements and scalable solutions. Education and Experience Required Experience & Skills Minimum of 5+ years of experience in a System Analyst, Business Analyst, or Functional Consultant role supporting SAP ERP systems, with significant exposure to SAP S/4HANA. 5 + years of direct, hands-on experience leading GxP Change Control and Validation execution within the pharmaceutical, biotech, or life sciences industry. Expertise in GxP regulations including 21 CFR Part 11, GAMP 5, and Computer System Validation principles. Proven experience in authoring GxP Documentation (SOPs, WIs, URS, FS, Test Scripts, Validation Protocols). Deep functional knowledge of at least two core SAP modules relevant to Pharma (e.g., QM, PP, MM, SD). Strong analytical and problem-solving skills, with an exceptional ability to focus on detail and documentation accuracy. Excellent communication and interpersonal skills, with proven ability to collaborate effectively with Quality Assurance and senior business stakeholders. Preferred Experience & Skills Experience with SAP Change Management tools (e.g., SAP Solution Manager/CHARM) and Cloud ALM. Experience with Quality Management Systems (QMS) integration with SAP (e.g., Veeva Quality). Experience with SAP Business Technology Platform (BTP) applications. Relevant SAP or ITIL certifications. The base salary range for this role is $99,400 to $123,800. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars. Our Mission To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide Our Vision For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas
Lead design, configuration, and support of SAP S/4HANA solutions across pharmaceutical supply chain functions, ensuring compliance and integration. | Minimum 5+ years of SAP ERP experience with expertise in SAP S/4HANA modules, pharmaceutical industry regulations, and system integration. | Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Senior Functional Analyst, Enterprise Apps, Tech Ops Job Overview We are seeking a highly motivated and experienced Senior Functional Analyst and Solution Lead to drive our digital transformation within the pharmaceutical supply chain. This pivotal role requires deep, cross-functional SAP S/4HANA expertise across the entire Procurement-to-Payment and Order-to-Cash cycles, with a mandatory focus on GxP Data Management and seamless integration with Financial modules (GL, AP, AR). You will be responsible for leading the design, configuration, optimization, and operational support of SAP S/4HANA solutions across key business functions, including GxP Master Data Management in Commercial and Clinical Supply Chain, Procurement, Manufacturing, Inventory, Sales & Distribution, and their integration with both external systems (Salesforce, CGTO) and internal finance processes. This is a challenging opportunity for a seasoned professional to ensure compliant, efficient, and fully integrated operations. Job Duties and Responsibilities 1. Cross-Functional Solution Design & Configuration End-to-End Process Ownership: Lead the analysis, design, configuration, and implementation of SAP S/4HANA solutions across the integrated supply chain, including: Procurement (MM): Procurement and Inventory Management. Manufacturing (PP): Production Order integration and execution (Production-to-Delivery). Order Management (SD/LE): Sales Order processing, Delivery, Logistics, and complex Intercompany transactions. Logistics & Shipment (LE): Transportation, shipment execution, and trade compliance. GxP Clinical and Commercial Master Data – Material Master, Bill of Material, Routing, Production Version, Quality Management Master Data etc. Configuration Mastery: Expertly configure and customize SAP S/4HANA modules (MM, SD, LE, PP, EWM, QM) to align with specific pharmaceutical business processes, focusing on batch management, material master data, and serialized inventory requirements. Design Workshops: Lead design workshops to gather detailed business requirements and translate them into robust Functional Specifications (FS) and configuration documents. 2. Financial & Enterprise Integration Supply Chain to Finance Integration: Ensure the seamless and accurate integration between supply chain transactions and Financial Accounting, including General Ledger (GL), Accounts Payable (AP) from Procurement, and Accounts Receivable (AR) from Order Management/Invoicing. External Integration Leadership: Design, implement, and maintain complex, compliant data flows between SAP S/4HANA and critical external systems: Salesforce: Integration for Order-to-Cash processes (Sales Order creation, delivery tracking). CGTO: Integration with Cell and Gene Therapy Operations systems for patient-specific manufacturing and logistics traceability. Data Migration: Conduct data migration activities, ensuring data integrity, accuracy, and compliance throughout the transfer process from legacy systems into the new SAP environment. 3. GxP Data Management & Validation GxP Data Stewardship: Serve as the functional expert for GxP Data Management, ensuring compliance, integrity, and traceability for all regulated data (e.g., batch records, material master, quality inspections) within SAP. Compliance Assurance: Ensure that the SAP S/4HANA design and implementation comply with industry standards and pharmaceutical regulatory requirements (GxP, 21 CFR Part 11). Validation & Testing: Actively participate in all validation activities: Develop detailed test plans and scripts for Unit, System Integration (SIT), and User Acceptance Testing (UAT). Execute test cases and collaborate with QA/testing teams to analyze results and resolve defects within the validated environment. 4. Production Support & System Optimization Solution Documentation: Develop and document detailed functional designs, configuration documents, and user manuals. Post-Implementation Support: Provide critical Tier 2/3 post-implementation support, including advanced troubleshooting, issue resolution, and complex user training on new SAP functionalities. Continuous Improvement: Monitor and analyze system performance, identify areas for process and configuration improvement, and recommend enhancements based on the latest SAP S/4HANA updates and best practices. Education and Experience Required Experience & Skills: Minimum of 5 + years of experience in implementing and configuring SAP ERP systems, with a strong focus on SAP S/4HANA in a complex, integrated landscape. Proven, comprehensive expertise across the integrated supply chain modules: SD, MM, LE, and PP. Knowledge of EWM and QM is highly desirable. Deep understanding of finance integration points (GL, AP, AR) with supply chain transaction data (MM-FI, SD-FI). Mandatory expertise in pharmaceutical industry regulations (GxP, data integrity, validation) and the handling of GxP-critical data within SAP. Proven experience in designing and implementing integrations with external enterprise systems, particularly Salesforce. Strong analytical, problem-solving, and leadership skills, with a track record of driving complex projects to completion. Excellent communication, collaboration, and stakeholder management skills. Preferred Experience & Skills: Experience with Cell and Gene Therapy Operations (CGTO) processes and related SAP/integrated systems. Experience with SAP Business Technology Platform (BTP) applications. Certification in relevant SAP S/4HANA modules (e.g., SCM or Sales). Experience leading or mentoring functional teams. The base salary range for this role is $80,000 to $100,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars. Our Mission To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide Our Vision For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas
Oversee and optimize the company's vehicle fleet operations, including policy development, vendor negotiations, and compliance. | Bachelor's degree in Business or related field, 6+ years in fleet management, experience in healthcare/pharmaceutical industry preferred. | Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Fleet that will oversee the strategic and operational management of the company’s vehicle fleet. This role ensures cost-effective, safe, and compliant fleet operations while supporting the needs of the commercial field force and other business units. Job Duties and Responsibilities • Manage all aspects of the company’s fleet program, including vehicle acquisition, inventory, maintenance, fuel programs, and disposal. • Develop and implement fleet policies and procedures to ensure compliance with safety, regulatory, and environmental standards. • Manage the Fleet Management Company (FMC) and partner with manufacturing brands to negotiate contracts • Monitor fleet performance metrics and identify opportunities for cost savings and operational improvements. • Coordinate with HR to support onboarding/offboarding of field-based employees. • Ensure accurate and timely reporting of fleet data, including mileage, fuel usage, and incident tracking. • Lead initiatives to improve sustainability and reduce the company’s carbon footprint. • Serve as the primary point of contact for fleet-related inquiries and issue resolution. • Manage the end-of-year driver-tax reporting process for company drivers, ensuring compliance with IRS guidelines and accurate reporting of taxable fringe benefits Key Core Competencies • Strong organizational and project management skills • Excellent negotiation and vendor management abilities • Analytical mindset with attention to detail • Effective communication and interpersonal skills • Proficiency in fleet management software and Microsoft Office Suite • Knowledge of DOT, OSHA, and other relevant regulations Education and Experience • Bachelor’s degree in Business Administration, Logistics, Operations Management, or related field • Minimum 8 years (w/o masters) or 6 years (w/Masters) experience in fleet management or related operations areas. • Experience in the pharmaceutical or healthcare industry preferred The base salary range for this role is $119,200 to $149,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Our Vision and Culture At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars. Our Mission To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide Our Vision For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas
Lead strategy and execution of data-driven commercial analytics and market research to support pre-launch pharmaceutical product decisions and advise senior leadership. | 15+ years in pharmaceutical/healthcare marketing analytics with strong strategic, analytical, and communication skills, and advanced degree preferred. | Description: • Lead the strategy and execution of data-driven insights to support commercial decision-making on pipeline products. • Act as the primary advisor to all Commercial Analytics & Field strategy functions as it relates to new approaches to analytics and market research techniques. • Responsible for pre-launch commercial analytics for products in development. • Assess commercial marketplace for pipeline products through primary and secondary research. • Partner closely with Medical, Business Development, Finance and all areas of commercial in the establishment of analytics plans and the delivery of unbiased, insightful data-driven analyses in support of all pre-commercial assets. • Establish competitive landscape and competitive intelligence for pre-commercial assets. • Partner cross-functionally with the market research team to connect primary market research and secondary data analytics to tell a compelling and persuasive story and deliver clear and actionable recommendations to leadership. • Drive innovation in analytics and business execution to positively impact brand performance and efficiency. • Develop and implement an analytics and market research launch playbook. Requirements: • Bachelor’s Degree in Life Sciences, Marketing, Business Administration or a related field; MBA or advanced degree is preferred • A minimum of 20+ years (w/o Master's) or 15+ years (with Master's) of experience in the pharmaceutical or healthcare industry, with a strong focus on marketing strategy, data analytics, and insights. • 15+ years of domain expertise in marketing, data analytics, or other related strategic analytics. • Proven track record of enabling data-driven decision-making at a senior leadership level. • Strong analytical background, strategic thinking and problem-solving skills, with the ability to analyze complex and dynamic data sets into actionable insights and aligning them with business priorities to drive impactful results. • Excellent communication skills, capable of effectively collaborating with leadership across sales, marketing, finance and medical functions and present complex insights effectively to diverse audiences. Benefits: • merit-based salary increases • short incentive plan participation • eligibility for 401(k) plan • medical, dental, vision, life and disability insurances • leaves provided in line with your work state • flexible paid time off • 11 paid holidays • additional time off for a shut-down period during the last week of December • 80 hours of paid sick time upon hire and each year thereafter
Lead strategic sourcing and contract negotiations for R&D services, develop category strategies, manage supplier performance and risk, and collaborate cross-functionally to drive value and efficiency. | Bachelor’s degree with 6-12 years of strategic sourcing/procurement experience in pharmaceutical or related industries, strong negotiation and analytical skills, and experience with sourcing platforms and contract lifecycle management. | Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com Job Description: The Strategic Sourcing Manager will drive value for the business by partnering with stakeholders across multiple departments to deliver source-to-contract activities for various R&D services. This role is responsible for negotiating and contracting with the supply base and ensuring alignment with established category strategies and overall business plans. This role requires an experienced Sourcing/Procurement manager to deliver strategic sourcing, contract management, supplier market intelligence, financial productivity, supplier performance management, and risk mitigation. The Strategic Sourcing Manager must be a change agent, leading by example while remaining in sync with the overarching direction and evolution for the Strategic Sourcing organization. The role requires active category knowledge and change management support that challenges traditional spending behavior, service level definition, and policy setting to enable productivity and efficiency improvements. The role requires development and execution of Sourcing Category Plans including negotiating and contracting with the vendor base, ensuring alignment with the Strategic Sourcing Category Strategies and overall Business goals & objectives. Strong collaboration with business partners and peers is essential for success. This individual will continually seek out opportunities to be a proactive advisor to the business, while maintaining deep knowledge and expertise in the dynamics of the supply markets and delivery models of suppliers and must be comfortable leading analytics efforts to proactively identify sourcing opportunities. Essential Functions Required for Job • Manage strategic sourcing, contract management, supplier market intelligence, financial productivity, supplier performance management, and risk mitigation across various R&D services. • Develop and implement sourcing category strategies that align with those of the functional goals & objectives for the business • Establish effective ongoing relationships with key stakeholders to ensure Strategic Sourcing activities effectively support functional strategies • Define and implement a strong concept of supplier management that enables a sustainable competitive advantage; maintain focus on supplier risk and performance management • Maintain knowledge and expertise with various R&D services. Effectively negotiate service level agreements/key performance indicators, and deep understanding of levers to achieve optimal value • Negotiate and redline service contracts and statements of work, utilizing a contract management platform • Generate sourcing insights utilizing spend analytics, industry intel and benchmarking data Click or tap here to enter text. • Lead end-to-end competitive sourcing activities (RFx) to include; bid list generation, requirements, supplier selection criteria/weighting, cost analysis, business case and award notification • Maintain sourcing practices that are in accordance with corporate ethics, financial policy, and internal control requirements • Pursue ongoing development of relevant skills, including learning agility, using data to provide insights, business partnering, change and project management, category management and strategic sourcing to realize optimal results KNOWLEDGE AND SKILLS Knowledge and skills indicate the education level, previous experience, specific knowledge, skills, and abilities necessary to meet the minimum requirements for this position. Education & Experience • Bachelor’s degree required; MBA or other advanced degree preferred. • Minimum 8 – 12 (w/o Master’s) or 6 – 8 years (with Master’s) years of relevant experience in strategic sourcing & procurement. • Preference toward experience in [BUSINESS] spend categories. • Pharmaceutical, Healthcare, Medical or Life Sciences experience a bonus. • Relevant experience: 3-5 years with Strategic Sourcing & Procurement experience across a range of service categories in the R&D space, preferably with CRO and ancillary vendor contract negotiation and oversight responsibilities. Pharmaceutical, Healthcare, Medical or Life Sciences industry experience a bonus. • Technology: Capable with common sourcing platforms including contract lifecycle management, e-sourcing, spend analytics, and supplier risk management. A strong desire and innate capability to learn. • Leadership: effectively contribute to and lead cross-functional teams, excellent written and verbal skills, strong negotiation skills, interpersonal skills, problem solving, effectively communicate/influence/manage change, anticipate and respond to change with ease and agility, seek solutions to strengthen quality/value/service/efficiency. • Analytics: Has an analytical mind and is comfortable generating spend analysis to drive opportunity insights. Can translate insights into action plans. • Business Partnering: Demonstrate a collaborative and consultative approach to foster meaningful relationships with key business leaders. • Fosters Change and Innovation: Seek solutions that strengthen quality, value, service, and effectiveness. Respectfully challenge the way “things are done” and supports others in doing so. • Creates Value for Customers: Anticipate and respond to market trends and opportunities. Deliver on promises made. • Demonstrates Business Acumen and Business Agility: Understanding of business specifics and engage in effective operational and strategic planning. Other requirements (licenses, certifications, specialized training, and physical or mental abilities required): CPSM/CPM a plus. Work hours may include meetings scheduled outside normal working hours. Travel up to 10%. The base salary range for this role is $126,200 to $157,800. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Our Vision and Culture At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars. Our Mission To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide Our Vision For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas
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