CSafe Global jobs - 28 jobs

Job Description CSafe is seeking a Mobile Engineer at our World Headquarters, in Monroe, Ohio to join our world class Software Engineering team! You will lead the development of a cross-platform mobile app using React Native and TypeScript, delivering both public (ungated) and authenticated (gated) experiences with high performance, strong security, and a consistent UI across our product portfolio. You'll partner closely with product, design, internal platform teams, and third-party build partners, and integrate the app with internal APIs and services. You will be reporting directly to the Director of Software Engineering. CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive the medicines and treatments they need. In addition to key acquisitions, CSafe has operations in more than 70 locations worldwide to ensure product availability and continue to fulfil our founders' mission to provide patients around the world with access to viable, life-enhancing pharmaceuticals. With a “client-first” focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading products provides an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases. Our team operates with curiosity, humility, accountability, and entrepreneurial spirit to deliver on our vision and mission. Come join our growing industry and build your career with us! What You'll Do: Build and ship high-quality React Native features for iOS and Android, maintaining cross-platform parity and a shared design system/theme Integrate with internal APIs including pagination, retries, offline caching/sync, and real-time updates where appropriate Create and maintain a component library for consistency across apps; enforce accessibility and responsiveness standards Work with device capabilities and native modules (e.g., NFC, camera/QR/barcode scanning, secure storage, background tasks, notifications) Own mobile CI/CD (Azure DevOps), code signing, and release management to the App Store and Google Play Instrument analytics, logging, and crash reporting; monitor performance (startup time, memory, ANRs) and drive continuous optimization Write reliable tests (unit, integration, E2E) and maintain a healthy automation suite. Collaborate with internal teams and third-party partners to plan, estimate, and deliver increments, document architecture and decisions What You'll Bring: Degree in Computer Science, Software Engineering, or IT or equivalent work experience 2+ years building mobile applications, including 1+ years with React Native + TypeScript in production Strong grasp of mobile architecture (state management, navigation, data fetching/caching, OTA updates) and platform differences (iOS vs. Android) Proven experience with secure auth flows, secure data storage (Keychain/Keystore), network security (TLS/cert pinning), and privacy best practices Comfortable integrating native modules and bridging to Swift/Kotlin when needed Hands-on with mobile CI/CD, store submission processes, release strategies, and feature flagging/experimentation Excellent collaboration and communication skills; experience working with onshore/offshore vendors Performance profiling (Flipper, Xcode Instruments, Android Studio Profiler) and advanced React Native tooling (Reanimated, Gesture Handler), is a plus Background sync/queues, push notifications, and real-time transports (WebSockets), is a plus Familiarity with design systems, internationalization, and advanced accessibility on mobile, is a plus Proven decision-making abilities Ability of prioritize and multitask Extremely organized, detail-orientated and able to work with minimum supervision Why Join Us: At CSafe, we foster an exciting, collaborative, and inclusive work environment that promotes personal and professional growth. We encourage feedback, foster trust, and support a culture of inclusion where everyone's voice matters. Be Part of a Growing Industry by joining a forward-thinking team in the rapidly expanding temperature-controlled shipping sector. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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 ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. 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 ********************************** 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 ********************************************** 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_

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 ********************************** or follow us on LinkedIn. We are seeking a highly skilled and collaborative **Senior Manager, Web Development** to lead the design, development, and support of our company's external web properties. This includes websites supporting Marketing, Corporate Communications, and Medical Affairs. The ideal candidate combines front-end development expertise with excellent communication and leadership skills to translate business needs into elegant, secure, and scalable web solutions. **Key Responsibilities** + Lead the Web Services team in building and maintaining public-facing websites on the AWS platform using Vue.js and Nuxt frameworks. + Partner with business stakeholders across Marketing, Corporate Communications, and Medical Affairs to gather requirements, propose solutions, and ensure align with corporate branding and compliance standards. + Oversee the full web development lifecycle - architecture, development, testing, deployment, and ongoing optimization. + Manage vendor and agency relationships for specialized design, content, and quality assurance. + Ensure web solutions adhere to industry best practices for security, accessibility (WCAG), SEO, and performance. + Champion agile delivery practices and modern CI/CD pipelines to ensure quality and efficiency. + Mentor front-end developers and establish coding standards and development best practices. + Stay current with emerging web technologies, frameworks, and regulatory guidance relevant to pharmaceutical digital content **Required Qualifications** + Bachelor's degree in Computer Science, Information Technology, or a related field (or equivalent experience). + 8+ years of experience in front-end web development, including Vue.js, Nuxt, Node.js, JavaScript, HTML5, CSS3, Tailwind CSS, GitHub, ColdFusion, MySQL. + 3+ years in technical leadership or management role overseeing web development projects and managing development teams. + Hands-on experience deploying and managing web applications on AWS (e.g., CloudFront, S3, Lambda, API Gateway). + Experience integrating web platforms with analytics tools (Google Analytics, Google Tag Manager, Google Search Console) and tag management systems. + Strong understanding of responsive design, accessibility standards, and SEO principles. + Proven ability to coordinate various timelines, cross-functional teams, and external resources to meet deadlines. + Excellent communication and collaboration skills, with the ability to translate technical concepts for non-technical stakeholders. + Proven track record managing multiple projects and priorities simultaneously in a fast-paced environment. + Exceptional attention to detail and a commitment to delivering high-quality, error-free solutions. + Experience within the pharmaceutical, biotech, or healthcare industries. + Familiarity with digital content approval workflows (e.g. Veeva PromoMats or equivalent). The base salary range for this role is $140,900 to $176,100. 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 ********************************** 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 ********************************************** 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_

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 ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist II. This position will be part of the Translational Research and Medicine-Oncology team, with a primary focus on advancing translational research to support oncology programs in clinical trial stages. This individual will be responsible for designing, oversighting, and interpretating translational studies to understand mechanism of action, resistance pathways, and potential new indications. The candidate may also be involved in biomarker analysis to support these translational objectives. **Job Duties and Responsibilities** + Develop hypotheses by integrating insights from scientific literature, preclinical and clinical data + Design experiments to support identification of mechanism of action, resistance mechanisms, and potential indications + Manage translational research and biomarker studies conducted with CROs and academic investigators to ensure high-quality, timely delivery of data + Maintain organized, detailed logs of studies and data to ensure accuracy, reproducibility, and compliance with regulatory standards + Present data and insights in internal meetings and cross-functional program team discussions **Key Core Competencies** + Scientific curiosity with ability to generate and test hypotheses that inform drug development + Excellent problem-solving and critical-thinking skills to interpret complex data + Strong organizational skills and attention to detail in managing studies, data, and documentation + Strong project management and vendor oversight skills + Adaptability and resilience in a fast-paced, evolving research environment **Education and Experience** + PhD degree in a related field of science (Biology, Biochemistry, Molecular & Cellular biology, Cancer Biology, Immunology) + 1-3 years of postdoctoral or industry research experience + Familiarity with oncology research preferred + Experience with common biomarker platforms (e.g. NGS, flow cytometry, IHC) preferred The base salary range for this role is $102,000 to $127,000. 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 ********************************** 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 ********************************************** 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_

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 ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced in Oncology. In addition, the candidate must have recent Oncology NDA submission experience and submissions worldwide including HTA submissions. The individual will be responsible for leading development of all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. In addition, the candidate must be experience with supporting all aspects of global commercial product. The role will hold accountability for regulatory submissions, applicable communications, and compliance across the company's new and established programs. This position reports to the Chief Medical Officer. **Job Duties and Responsibilities** + Strategic thought partner including with but not limited to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion of prescription drugs + Guide and/or lead regulatory agency interactions, including communications and meetings + Provide strategic and operational leadership to the Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion in accordance with business goals and objectives, regulations, guidelines, and company policy. + Manage and/or support the development and implementation of policies, procedures and tools related to advertising, promotion, and labeling + Manage compliance and risks related to R&D activities, especially activities of regulatory affairs, (e.g., SOPs) + Set clear standards and expectations for the accurate and timely reporting of status of all regulatory affairs activities; provide relevant input to Leadership + Oversee the regulatory activities at CROs, providing document review in order to ensure the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims and assess consistency of proposed claims with FDA-approved labeling + Provide regulatory leadership to the respective cross-functional teams charged with advertising and promotion review to ensure compliance of promotional materials including, but not limited to, Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations and press releases and external communications in compliance with FDA regulations and Company policies + Serve as the regulatory member of the scientific Medical Review Committee (sMRC) to ensure regulatory compliance for medical based communications, congresses, and ad boards. + Serve as primary contact leading and facilitating communications with the OPDP reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products, including pre-clearance of launch materials. + Direct and ensure the timely submission of all applicable approved promotional materials to the FDA on Form 2253s + Ensure compliance of labeling, promotional and educational materials with governing Health Authorities. + Managing responsibilities for direct reports within the commercial regulatory team for both product promotional review and product promotion submissions to FDA for both women's health and prostate cancer + Recruits, develops, manages and mentors regulatory professionals and drives a culture of excellence and motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals + Provide leadership and direction to clinical regulatory. Provide coaching and development and drive a culture of excellence that motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals. **Key Core Competencies** + Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively + Exercise good judgment and make decision that is appropriate for the organization + Results-driven, take initiative and ownership to accomplish work + Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment + Strive for continuous improvement and embrace innovative ideas in daily work + Demonstrate coaching skill to inspire, develop, and motivate team + Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables. + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + Advanced degree in a relevant scientific discipline required. + Doctoral degree (MD, PharmD, or PhD) preferred + 15 years of biopharmaceutical experience, which include at least 10 years of direct experience in Regulatory Affairs in Oncology + Demonstrated experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA Experience in Oncology required + Demonstrated leadership skill leading a functional team + Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional) + Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (eg, changing regulatory environment, new competition, shifting market environment) along with the ability to balance short-term needs with long-term vision. The base salary range for this role is $280,560 to $350,700. 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 ********************************** 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 ********************************************** 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_

Job Description CSafe, a global leader in temperature-controlled shipping solutions, is looking for a Legal Counsel to join our dynamic and world-class organization at our World Headquarters in Monroe, Ohio. In this role, you will play a key role in supporting the organization by drafting, reviewing, and negotiating commercial contracts and other legal documents. This role is ideal for a detail-oriented attorney who thrives in a fast-paced business environment and enjoys partnering with cross-functional teams. You will help ensure the company's contractual relationships are legally sound, aligned with internal policies, and supportive of broader business objectives. You will report directly to the Head of Legal. CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive the medicines and treatments they need. In addition to key acquisitions, CSafe has operations in more than 70 locations worldwide to ensure product availability and continue to fulfil our founders' mission to provide patients around the world with access to viable, life-enhancing pharmaceuticals. With a “client-first” focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading products provides an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases. Our team operates with curiosity, humility, accountability, and entrepreneurial spirit to deliver on our vision and mission. If you are a proactive, solution-oriented legal professional with a passion for business law and a drive to make an impact, we want to hear from you! What You'll Do: Contract Drafting & Review Draft, review, and revise a wide range of commercial contracts, including NDAs, vendor agreements, service agreements, sales contracts, and licensing agreements. Identify contractual risks and propose revisions to protect company interests. Ensure all agreements adhere to company policies and applicable laws. Negotiation & Collaboration Assist in negotiating contract terms with customers, suppliers, and other external stakeholders. Partner with internal teams-including procurement, sales, HR, operations, and others-to understand business needs and provide practical legal guidance. Support the legal department in addressing complex contract matters. Legal Research & Advising Conduct research on relevant laws, regulations, and legal precedents. Provide clear, concise legal recommendations to internal stakeholders. Monitor regulatory changes impacting contracts or business operations. Compliance & Documentation Maintain organized contract records and ensure compliance with document management protocols. Assist in developing and updating templates, playbooks, and contract process improvements. Support audits and broader compliance initiatives as needed. Working Conditions In office requirement - three (3) to four (4) days a week. Occasional travel may be required for training, meetings, or vendor/customer interactions. What You'll Bring: Juris Doctor (JD) from an accredited university law school Active membership in at least one U.S. state bar (Ohio preferred or ability to obtain Corporate Counsel Registration in Ohio) 1 plus year of experience in contract drafting, review, or negotiation (in-house or law firm). Strong attention to detail and excellent analytical, writing, and communication skills. Ability to balance legal risk with business objectives and provide pragmatic guidance. Comfortable working independently and collaboratively in a fast-paced environment. Experience with contract lifecycle management systems or document management platforms, preferred. In-house experience (internship or full time) is a plus. Knowledge of industries involving manufacturing, logistics, life sciences, or technology, is a plus. Why Join Us? At CSafe, we foster an exciting, collaborative, and inclusive work environment that promotes both personal and professional growth. Here's what we offer to our employees: Opportunity to work closely with a growing, collaborative international legal team. Exposure to a broad range of commercial matters and cross-functional projects. Meaningful role supporting business strategy and operational execution. Top of Form Bottom of Form Strong knowledge of Microsoft Office, including Word, Excel, and Outlook Open to new possibilities and challenges. Paid Time OFF (PTO) starting at 25 days & Paid Holidays Medical, Dental and Vision Insurance 401k with Employer Match Group Life & Disability Health Spending Account Options Identity Protection Employee Assistance Program Travel Assistance Program Financial Wellness Program Tuition Reimbursement Parental Leave Referral Program Gym Membership Reimbursement An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job Description CSafe is seeking an AI & Machine Learning Engineer at our World Headquarters, in Monroe, Ohio to join our world class Software Engineering team! You will develop and deploy intelligent systems that optimize logistics and cold chain operations. You'll build generative AI, simulation, and predictive models that enhance routing, efficiency, and reliability across the supply network. The ideal candidate combines deep technical expertise in machine learning and data science with practical experience implementing scalable solutions in complex, enterprise environments. You will be reporting directly to the Director of Software Engineering. CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive the medicines and treatments they need. In addition to key acquisitions, CSafe has operations in more than 70 locations worldwide to ensure product availability and continue to fulfil our founders' mission to provide patients around the world with access to viable, life-enhancing pharmaceuticals. With a “client-first” focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading products provides an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases. Our team operates with curiosity, humility, accountability, and entrepreneurial spirit to deliver on our vision and mission. Come join our growing industry and build your career with us! What You'll Do: Design, train, and deploy machine learning models for demand forecasting, routing optimization, and network efficiency Integrate AI systems with existing logistics platforms, sensors, and data pipelines Collaborate with cross-functional teams to translate business challenges into scalable solutions Implement data processing, feature engineering, and model evaluation pipelines using modern frameworks Monitor model performance, retrain systems, and ensure continuous improvement through feedback loops Ensure AI systems meet enterprise standards for security, scalability, and data governance Stay current with advancements in machine learning, optimization algorithms, and generative AI relevant to logistics What You'll Bring: Degree in Computer Science, Software Engineering, or IT or equivalent work experience 5+ years in ML/AI roles with deep statistical learning experience Deep knowledge of Generative AI, NLP, and simulation methods applied to operational and logistics challenges Proficiency in Python and common ML frameworks (TensorFlow, PyTorch, Scikit-learn) Experience with data engineering tools and environments (SQL, Spark, Databricks, Airflow) Familiarity with cloud platforms (AWS or Azure) and MLOps practices for deploying and monitoring models Ability to analyze large, complex datasets to uncover actionable insights and automation opportunities Strong problem-solving skills with a focus on scalability and real-world application Excellent collaboration and communication abilities Why Join Us: At CSafe, we foster an exciting, collaborative, and inclusive work environment that promotes personal and professional growth. We encourage feedback, foster trust, and support a culture of inclusion where everyone's voice matters. Be Part of a Growing Industry by joining a forward-thinking team in the rapidly expanding temperature-controlled shipping sector. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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 ********************************** or follow us on LinkedIn. We are currently seeking a dynamic individual who will serve as administrative support to the Legal Department, responsible for performing legal administration activities, supporting process improvements, and identifying operational efficiency opportunities across the legal function. This role is essential in ensuring the department operates with optimal effectiveness, aligning with the broader goals of the organization. **Job Duties and Responsibilities** _Process Improvement & Operational Efficiency_ + Identify, design, and implement scalable legal processes and workflows to improve efficiency and reduce risk. + Support all aspects of setting up and maintaining purchase orders. + Support work orders and invoicing under intercompany and external vendor agreements. + Obtain and submit accruals from external vendors in compliance with applicable laws. + Support Chief Legal Officer's direct reports with meeting scheduling and expense reports. + Review and distribute mail in compliance with company data retention schedule. + Manage Legal Teams channel and filing site in compliance with company data retention schedule, and to ensure consistent organizational structure and efficient access to information. _Project & Vendor Management_ + Support legal department projects and initiatives (e.g., system/process implementations, restructuring activities), including timelines, deliverables, and stakeholder communications. + Retrieve contracts from and uploading contracts to ECMS (CLM). + Oversee relationships with external counsel and legal vendors, including ensuring engagement letters are in place and on file, and POs in place. + Monitor legal spend and support budgeting, forecasting, and cost-saving initiatives. _Compliance & Governance_ + Support corporate governance activities, including board documentation, policy development, regulatory filings, and entity restructuring. + Ensure legal operations align with pharmaceutical compliance standards and industry regulations. _Team Collaboration & Communication_ + Act as a liaison between legal and other departments to ensure seamless legal service delivery. + Support preparation of PowerPoint presentations. **Key Competencies** + Experience supporting legal teams in a regulated industry. + Ability to manage multiple priorities in a fast-paced environment. + Strategic thinker with a continuous improvement mindset. + Comfortable working with senior leadership and cross-functional teams. **Education and Experience** + Bachelor's degree required; paralegal certification preferred. + 3-5 years of experience in legal administration with some operational experience + Demonstrated experience in process improvement, project management, and cross-functional collaboration. + Proficiency in legal tech platforms (e.g., CLM (ECMS/iCertis), e-billing, Oracle, SAP, Workday, PowerPoint, Word, Excel) preferred. + Excellent organizational, analytical, and communication skills. The base salary range for this role is $62,600 to $78,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, overtime, 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 up to 120 hours of vacation per year, 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 and access to our service recognition program. 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 ********************************** 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 ********************************************** 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_

Director, Corporate Accounts Reports To: Area Director, Corporate Accounts Are you looking to make a difference in your career and become part of an innovative, global medical device company? Ambu is a global industry leader with the soul of a startup. Our dedicated and passionate team members are driven by our mission to save lives and improve patient care through innovative medical devices and industry changing single use scopes. We are led by our Values: Take Charge, Team Up, and Be True. We are currently seeking a Corporate Accounts Director to be responsible for implementing the strategy to deliver incremental sales revenues based on penetrating assigned IDNs and/or GPOs across the region identified. He/she must establish strong relationships with Ambu product/sales divisions (Anesthesia and Endoscopy) to partner in reaching collective sales targets. The Corporate Accounts Director must have a proven track record of success in corporate accounts; have utilized value-based selling through Health Economic reporting; have run demonstrations; and have managed large scale evaluations from start to finish. Ultimately, you will lead the efforts in sustaining and growing Ambu's full line of products within our top customers to achieve short and long-term success. Essential Functions and Responsibilities: * Achieve annual sales objectives in assigned Distribution, GPO, Government and Key/Integrated Delivery Network (IDN) accounts and drive the successful implementation of account specific strategies, based on alignment with and direction from the Vice President, Corporate Accounts * Identify opportunities within the Distribution, GPO, Government, and IDN environment along with key stakeholders, which includes gathering key decision-making criteria, effective opportunity qualification, and gaining customer commitment through a complete understanding of customer specific personal, professional, and business goals * Provide high levels of communication with executive and sales management teams * Develop and maintain strong relationships with assigned key accounts ensuring complete satisfaction and brand loyalty across categories * Assist with developing sales strategies to increase all Ambu product market penetration * Collaborate with Areas Sales Directors, Regional Sales Directors, and Territory Managers to plan and coordinate sales activities to increase revenue within assigned portfolio * Present Health Economics data to create value-based selling with all assigned accounts * Prepare regular reports of progress to include forecasts and opportunity pipelines to internal and external stakeholders using key account metrics * Ensure that all organizational activities and operations are carried out in compliance with local, state and federal regulations and laws governing business operations * Consistently present the Ambu Value story within assigned accounts to defend current position and promote future product growth opportunities * Maintain sales expense budget as set by corporate management * Ensure regional pipelines are robust and updated consistently to ensure alignment with the Sales Plan * Utilize the complexity and importance of the assigned IDNs and/or GPO strategic accounts in order to manage and cultivate customer relationships, identify opportunities and employ account management skills * 50%+ overnight travel to visit with prospects, customers, and to attend tradeshows, as well as regional, corporate, and national meetings Qualifications and Skills: * Bachelor's Degree from an Accredited Institution, MBA preferred * Minimum of five (5) years of previous medical device sales experience, preferably in the critical care areas, with at least two (2) of those years having worked directly with IDNs/GPOs * Demonstrated and proven leadership abilities * Proven track record of consistently overperforming and excelling throughout your career * Highly organized and able to manage a large pipeline of perspective clients * Expert in analyzing and interpreting Health Economic data to drive conversions and penetration in strategic accounts * Excellent communication (verbal and written) and interpersonal skills * Strong problem-solving and negotiation skills * Experience in project management * Strong business acumen in data analytics, customer relationship management software, and Microsoft Suite * Ability to interact and form relationships with C-level management * Proficient in stakeholder management * Ability to understand relevant clinical areas and customer settings in order to see opportunities for value creation * Valid driver's license, in good standing AAP/EEO Statement Ambu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job Description The Cybersecurity Architect is responsible for designing, implementing, and maintaining secure architecture across the organization's cloud environments, with a strong focus on Microsoft Azure. This role ensures that security is embedded in all aspects of identity, data, applications, and operations, aligning with Zero Trust principles and enterprise governance frameworks. The architect will collaborate with DevOps, Enterprise Architecture, and Infrastructure teams to ensure secure cloud adoption, support compliance, and enhance the organization's overall security posture. CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive the medicines and treatments they need. In addition to key acquisitions, CSafe has operations in more than 70 locations worldwide to ensure product availability and continue to fulfil our founders' mission to provide patients around the world with access to viable, life-enhancing pharmaceuticals. With a “client-first” focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading products provides an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases. Our team operates with curiosity, humility, accountability, and entrepreneurial spirit to deliver on our vision and mission. Come join our growing industry and build your career with us! Key Responsibilities: Cloud Security Architecture and Engineering Secure Azure architecture for cloud workloads, networking, data, and applications. Implement Azure-native security controls and patterns including: Identity and Access Security: Microsoft Entra ID, Conditional Access, MFA, PIM, and PAW. Network Security: Azure Firewall, DDoS Protection, NSGs, Application Gateway (WAF), Private Link, and Hub-Spoke Topology. Data Security: Azure Key Vault, TDE, Always Encrypted, and Confidential Computing. Threat Detection: Defender for Cloud, Endpoint and Identity Design Zero Trust-aligned architectures based on the Azure Security Benchmark, Cloud Adoption Framework (CAF), and Microsoft's Enterprise-Scale Reference Architectures. Embed “security by design” into DevOps and CI/CD pipelines using automation, policy-as-code, and continuous compliance. Integration and Collaboration Partner with Enterprise Architecture and DevOps teams to implement security within Azure DevOps and GitHub pipelines. Collaborate with external Managed Detection and Response partners to align detection, response, and identity/device security practices. Governance, Risk, and Compliance (GRC) Develop and maintain cloud security governance frameworks aligned to NIST Cybersecurity Framework, Azure Security Benchmark, and CIS Controls. Define and enforce Azure Policy and Blueprints for compliance automation and regulatory reporting (NIST 800-53, ISO 27001, SOC 2, etc.). Lead security risk assessments and threat modeling for new Azure workloads and services. Support audits, remediation plans, and continuous improvement of Microsoft Secure Score and overall maturity. Innovation and Continuous Improvement Evaluate emerging Azure and AI-based security technologies to strengthen detection, response, and automation. Drive architecture improvements that reduce vulnerabilities, minimize attack surface, and optimize cloud posture. Promote best practices through documentation, training, and architecture reviews. Qualifications Bachelor's degree in Information Security, Computer Science, or related field. 7+ years of experience in cybersecurity architecture, with 3+ years focused on Microsoft Azure security. Deep expertise in Azure-native security services and Zero Trust design. Hands-on experience with Defender for Cloud, Azure Policy, Entra ID, and Azure Firewall. Certifications preferred: Microsoft Certified: Cybersecurity Architect Expert (SC-100) Microsoft Certified: Azure Solutions Architect Expert (AZ-305) Strong understanding of NIST CSF, CIS Controls, and Cloud Adoption Framework. Our Benefits Include: Paid Time OFF (PTO) starting at 25 days & Paid Holidays Medical, Dental and Vision Insurance 401k with Employer Match Group Life & Disability Health Spending Account Options Identity Protection Employee Assistance Program Travel Assistance Program Financial Wellness Program Tuition Reimbursement Parental Leave Referral Program Gym Membership Reimbursement Hybrid Work Options An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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 ********************************** or follow us on LinkedIn. The Senior Manager is a strategic leader responsible for overseeing Pharmacovigilance (PVRM) and non-PVRM vendor management, adverse event handling and reporting, and supporting global PV systems. This role oversees compliance training, quality monitoring, audit and inspection preparedness, and cross-functional initiatives to ensure operational excellence and regulatory adherence. The Senior Manager works closely with the PVRM Information Management (IM) and Safety Science groups and is a member of a cross-functional working team as part of a matrix team supporting PV activities. **Job Duties and Responsibilities** + Lead strategic relationships with PVRM and non-PVRM vendors, ensuring contract compliance, quality performance, and alignment with business objectives. + Provide strategic oversight of adverse event (AE) management and reporting processes, ensuring compliance with global regulatory requirements. + Conduct routine AE case quality checks, support special projects, and collaborate within PVRM and Quality on root cause analysis, corrective and preventive actions, effectiveness checks, and process improvements. + Lead audit and inspection preparedness, participate in cross-functional teams, and support regulatory inspections and internal audits. + Develop and maintain PV staff learning plans, manage compliance activities, and serve as the primary liaison for organized data collection and reconciliation of safety information. + Oversee the development, maintenance, and continuous improvement of standard operating procedures (SOPs) across PV operations and quality systems to ensure consistency, regulatory compliance, and operational excellence. + Support global safety planning and coordination, and maintain relationships with business partners, affiliates, and subsidiaries. + Provide expert support for Pharmacovigilance Agreements (PVAs), including but not limited to drafting, reviewing, and maintaining PVAs with internal and external partners. Support Alliance Management to ensure PVAs are compliant with global regulatory requirements and support the implementation and oversight of PVA obligations across the organization. + Contribute to standard operating procedures relevant to pharmacovigilance + Mentor and coach team members, foster a high-performance culture, and deliver results in a dynamic, fast-paced environment. + Assist with other department activities as needed. **Key Core Competencies** + Works effectively with minimal supervision. + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture. + Self-motivated with solid management skills, and the ability to lead or participate effectively in cross-functional teams. + Skilled mentoring and coaching to develop team deliverables. + Proficient verbal and written communication skills. + Proficient in MS Office applications and adaptable to technology and systems. + Knowledge of current US and international pharmacovigilance regulations. + Ability to multi-task under limited direction and on own initiative. + Excellent interpersonal, written and verbal communication skills. + Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. + Must have excellent customer-service orientation, high degree of professionalism, and ability to work with independently. + Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company. **Education and Experience** + Bachelor's degree required. Preferably in a scientific, regulatory, or health-related field; advanced degree preferred. + Minimum 8 - 10 years of relevant experience in healthcare industry. + Minimum 5 years of experience specific to Pharmacovigilance operations and compliance. + Project leadership/management skills. + Excellent understanding of U.S. regulations and guidances, and a strong working knowledge of global regulations and guidances, e.g., European Economic Area, United Kingdom, and Canadian regulatory frameworks. The base salary range for this role is $155,000 to $193,000. 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 ********************************** 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 ********************************************** 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_

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 ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Manager, Clinical Systems R&D IT Business Applications** who will serve as the primary liaison between R&D Clinical Operations team and IT, responsible for the delivery and support of technology solutions that align with business needs and operational demands. **_This role requires proficiency in implementing, integration, and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment_** **Job Duties and Responsibilities** + Partner with Clinical business stakeholders to co-create technology plans which support their business objectives and operational demands + Continuously assess current systems environment and identify changes (process and/or system) that enhance effectiveness + Assist in the evaluation of new technology systems and/or service providers + Oversee end-to-end management of IT projects-including planning, design, and implementation-ensuring projects are delivered on time, within scope, and with measurable business impact + Work with a team of managed service providers supporting the lines of business technology needs including project delivery, solution design, enhancement requests and support services + Accountable for managing clinical application systems through their full lifecycle, from implementation to ongoing optimization + Lead and initiate troubleshooting quality and/or functionality issues associated with technology systems in scope + Develop and maintain comprehensive project documentation, ensuring centralized storage and accessibility for knowledge management + Manage and prioritize system enhancements and fixes in collaboration with business stakeholders + Provide regular project status reports, manage issues proactively, and adjust schedules as needed while maintaining alignment with the overall program plan + Responsible for timely execution of all GxP system commitments and compliance activities (Backup recovery, Disaster Recovery testing etc.) + Collaborate with cross-functional IT teams to ensure seamless delivery of services, efficient communication, and shared accountability for outcomes + Establish clear performance metrics and service level agreements (SLAs) to monitor IT service delivery, project outcomes, and stakeholder satisfaction + Stay informed of emerging industry trends, best practices, and regulatory changes to proactively recommend technologies and process adaptations that empower the company during phases of rapid expansion + Serve as the IT subject matter expert for application upgrades, integrations, and system enhancements across supported business areas **Key Core Competencies** + Strong understanding of Clinical business processes, requirements and technology systems supporting Clinical Trials (e.g. EDC, CTMS, ETMF, Payments etc.) + 7+ years of progressively increasing experience managing clinical applications in a Pharma/Biotech company + Strong understanding of building and operating a technology support function + Proficient in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment **Education and Experience** + BS/BA degree in a related discipline is required. Training or equivalent experience in IT or business management is beneficial but not required + 7+ years of experience in life sciences with a focus on IT system delivery + 5+ years of experience in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment + Experience in Program & Project Management, including the Software Development Lifecycle and Computer Systems Validation process + Excellent communication skills The base salary range for this role is $127,440 to $159,300. 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 ********************************** 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 ********************************************** 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_

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 ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Support development of communications with Senior Executives and strategic partners to report analytical findings and key performance metrics + Develop models to set pricing strategy with the goal of supporting attainment of coverage goals and maximizing net revenue + Develop payer & provider deal models to assess the implications of deal scenarios on gross-to-net revenue and support development of business cases for review & approval by the Pricing Committee + Develop & refine gross-to-net models to support reporting and forecasting of short and long-range discount rates for Finance and the brand teams + Collaborate with the Market Access team on contract changes and amendments + Support roll-out of contracts to field staff + Review internal data/reports to ensure compliance with government pricing programs + Provide issue resolution and presentation of solutions from contract disputes + Support government price reporting and state price transparency reporting requirements **Key Core Competencies** + Experience in pharmaceutical secondary analytics and financial modeling + Understanding of Commercial and Medicare Part D pharmacy benefit designs + Understanding of gross-to-net and ROI calculations + Ability to prioritize and manage multiple tasks/assignments and meeting short deadlines + Interest in exploring and developing new approaches, processes and methodologies + Experience evaluating PBM/payer contracts to ensure they support Market Access objectives + Highly-skilled in influencing and effectively partnering with cross-functional teams + Excellent interpersonal, oral and written communication skills, project management, and confident executive presence + High level of proficiency with Microsoft Excel and PowerPoint + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + Bachelor of Arts or Science in Health Sciences or related discipline; MBA preferred + Minimum 15 - 20 years (without Master's) or 10 - 15 (with Master's) of relevant experience in biotech or pharmaceutical industry + 5-7 years' experience in data analysis, financial modeling, and decision support + Preference towards previous experience with product level forecasting The base salary range for this role is $183,360 to $229,200. 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 ********************************** 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 ********************************************** 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_

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 ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated individual for the position of **Multi-Specialty Portfolio Specialist/Associate Portfolio Specialist.** This position is being posted at multiple levels. Applicants for this position will be considered for the titles listed in this posting. The title and salary will be determined by the experience and qualifications of the final candidate. Candidates who do not meet all of the qualifications may be considered for an Associate level role. In this field-based role, the **Multi-Specialty Portfolio Specialist/Associate Portfolio Specialist** will focus on achieving sales goals within primary care, urology, and the women's health therapeutic area in an assigned geographic territory. This individual will have a proven record of success within specialty biopharmaceuticals. They will be highly collaborative, tactical, energetic and thrive in a nimble organization. The **Multi-Specialty Portfolio Specialist/Associate Portfolio Specialist** , will demonstrate a sense of urgency to prepare and successfully execute a new product launch plan for their assigned geography. The **Multi-Specialty Portfolio Specialist/Associate Portfolio Specialist** , will drive results that are consistent with the company's goals, mission, and values. **Job Duties and Responsibilities** Deliver Results + Consistently meet or exceed sales objectives by leading and implementing effective sales strategy in an ethical and compliant manner + Demonstrates resilience and consistent ability overcome obstacles to achieve objectives + Consistently demonstrate SMPA Values Business Planning and Execution + Develop and execute an effective business plan aligned to sales strategy to achieve sales results + Prioritize and call on the appropriate customers at the optimal frequency to change prescribing behaviors + Demonstrate effective pre-call planning prior to HCP engagement to establish a clear purpose for the sales call Impactful Selling + Move customers along the adoption continuum by driving market share growth + Demonstrate two-way dialogue with customer interactions by employing selling skills to generate dialogue, identify customer needs and active listening + Effectively utilize patient type selling with approved messaging and resources Infinite Mindset + Deploy growth mindset daily + Focus on opportunities not limitations + Expect success **Key Core Competencies** + Has a proven, consistent track record of exceeding sales goals in assigned geography or relevant experience. + Proven to be successful in all aspects of selling, i.e., clinical expertise, selling skills, and an in-depth understanding of the local ecosystem or relevant experience. + Understands, analyzes, and effectively presents scientific/technical details and marketing materials. + Proficient knowledge and understanding of the payer landscape including commercial, Medicaid, and Medicare or relevant experience. + Demonstrates the ability to analyze complex data to develop strategic and actionable business plans to deliver sales results. + Candidates must have excellent communication & organizational skills and be proficient with technology platforms and business hardware/software. **Education and Experience** + Bachelor's Degree is required, preferably in Business or Life Sciences. + Generally, the **Associate Portfolio Specialist** will require 0 - 3+ years of pharmaceutical sales experience and/or relevant experience. Demonstrated mastery or the aptitude to learn, product and disease state knowledge. + Generally, the **Portfolio Specialist** will require 3 - 5+ years of pharmaceutical sales experience and/or relevant experience. Demonstrated mastery or the aptitude to learn, product and disease state knowledge. + Travel within territory is required, which may include both car and overnight air travel depending upon territory. + Some national travel to corporate headquarters, training, product theaters and sales meetings is required on a periodic basis. + Work hours may include meetings scheduled outside of normal working hours. The base salary range for this role is $108,000 to $135,000. 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 ********************************** 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 ********************************************** 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_

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 ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This position is responsible for the preparation, coordination and monitoring of routine US and/or global regulatory submissions and responses to health authority (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as appropriate. This position works with a moderate level of independence and autonomy and requires some coaching and mentoring. **Job Duties and Responsibilities** + As a Regional Regulatory Lead, manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT) + As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs + Supports and/or leads documentation of regulatory authority interactions including decisions and outcomes + Leads and coordinates project team members in developing strategy for applicable documents/ activities. + Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission + Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level + Provide updates to the Global Regulatory Team, project teams, and governance boards as needed + Maintains professional working relationships with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed + Advises team members of potential regulatory issues and provides possible solutions and mitigation strategy + Ensures the quality and content of all submissions to Health Authorities + Contributes to regional health authority meetings, and briefing book documentation to Health Authorities + Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and regulatory department operating procedures, as needed. **Key Core Competencies** + Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required + Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values + Ability to work in a diverse environment + Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization + Demonstrated ability to facilitate appropriate team decisions + Sense of urgency and perseverance to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed + Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution + Contribution to the development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to make complex decisions and willingness to defend difficult positions. + Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in a related field required, preferably in a scientific discipline. + At least 7 years of experience, prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred + Experience contributing to electronic regulatory submissions and working with regulatory templates + Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials The base salary range for this role is $156,000 to $195,000 . 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 ********************************** 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 ********************************************** 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_

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 ********************************** or follow us on LinkedIn. **Position Summary** The Senior Manager **(Source-to-Applications)** will lead the solution, design, and delivery of the company's **Source-to-Pay (S2P)** technology ecosystem, encompassing **Coupa, SAP as ERP, and related integration layers** . This role is responsible for ensuring seamless process alignment between **Procurement, Finance, and Supply Chain** , optimizing technology investments, and enabling digital transformation through automation and data-driven insights. The ideal candidate combines **deep functional knowledge of procurement and finance processes** with strong technical acumen in **Coupa, SAP, integrations, and governance** . **Key Responsibilities** **Leadership** · Serve as the IT solution lead for Coupa, SAP MM/FI, and other related procurement and finance systems. · Partner with Procurement, Finance, and IT leadership to drive process optimization, compliance, and cost efficiency. · Champion best practices for digital sourcing, procurement analytics, supplier collaboration, and contract management. **Application & Integration Management** · Responsible for system configuration, enhancements and support for **Coupa modules** (Procure-to-Pay, Sourcing, Contract Lifecycle Management, Supplier Management, Invoicing). · Manage integrations between Coupa, **SAP ERP** , **Workday** , **banking** , and **3rd-party applications** using middleware. · Lead upgrades, testing, and change control processes across Coupa and SAP landscapes. **Operational Excellence** · Ensure compliance with internal controls, audit, and regulatory requirements (SOX, GDPR, etc.). · Drive data quality and master data governance across supplier, contract, and spend domains. · Manage MSP and vendor resources ensuring SLA adherence and value realization. **Team & Stakeholder Leadership** · Lead developers, and functional consultants for projects and support. · Act as a **trusted advisor** to Procurement and Finance leaders for digital transformation opportunities. · Collaborate with IT peers across ERP, HR, and analytics functions to deliver integrated enterprise solutions. **Qualifications** **Education:** Bachelor's degree in Information Systems, Finance, or Business Management (Master's preferred). **Experience:** · 10+ years of experience in enterprise applications or IT solution delivery. · 7+ years leading Source-to-Pay or Procure-to-Pay systems (preferably Coupa and SAP). · Proven experience managing large-scale ERP and SaaS integrations. · Strong understanding of end-to-end procurement, sourcing, invoicing, and payments processes. · Demonstrated success in project governance, vendor management, and stakeholder engagement. **Skills & Competencies:** · Expert in **Coupa functional configuration** and **SAP integration** (especially MM, FI, and AP modules). · Capable of translating complex business needs into scalable technical solutions. · Proficient with middleware SAP CPI and API-based integrations. · Knowledge of **workflow automation** , **RPA** , and **data visualization tools** (Power BI, Tableau) a plus. · Strong leadership, communication, and change management skills. **Preferred Certifications** - Coupa Certified Professional. - SAP certification (MM, FI/CO, or Integration). The base salary range for this role is $145,280 to $181,600. 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 ********************************** 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 ********************************************** 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_

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 ********************************** or follow us on LinkedIn. **Position Summary** The Business Applications team is part of IT and is responsible for supporting, developing, managing and enhancing the capability of enterprise applications which make up the platform that delivers SMPA's business processes. The Manager, Enterprise Apps, Workday Architect is responsible for partnering with HR to architect the company's HR applications including Workday and other integrated HR platforms (e.g., benefits, time tracking, learning, and recruiting, payroll systems). This role serves as the primary liaison between IT, HRIS, and HR stakeholders, ensuring that HR applications align with enterprise architecture standards, IT compliance requirements, and business goals. The ideal candidate has hands-on Workday experience, a strong understanding of HR processes, and proven success in leading system enhancements, integrations, and IT data governance initiatives. **Key Responsibilities** Systems Management & Architecture + Serve as the technicallead for **Workday** and other HR-related applications. + Design andmaintainthe **HR systems architecture** , ensuring alignment with enterprise IT standards and data governance policies. + Oversee Workday configuration, testing, and deployment across modules (HCM, Absence, Compensation, Talent, Recruiting, Learning, and others). + Manage integrations between Workday and downstream systems such as SAP, Payroll, Finance, and Identity Management platforms. + Ensure stability, scalability, and continuous improvement of HR systems through proactive monitoring and optimization. + Design,monitor, and troubleshoot integrations between Workday and external systems (e.g., ERP, Finance, Payroll providers, Identity Management). Stakeholder Engagement + Partner with HR, IT, and Finance stakeholders to deliver high-impact HR technology solutions. + **Primary liaison** for WorkdayTechnicalsupport, helpdesk, and enhancement requests. + Provide functional guidance and mentorship to HRIS analysts or other team members. Data, Reporting & Compliance + Managedata governance, ensuring accuracy, consistency, and compliance with data privacy and audit requirements. + Develop andmaintainreports, dashboards, and analytics to support business decisions. + Support internal and external audits by ensuring proper system controls and documentation. **Education & Experience:** + Bachelor's degree in information systems, Computer Science, Human Resources, or Business Management (Master'sdegree preferred). + 7+ years of hands-on Workday and HR Applications IT experience + Strong understanding of HR business processes (Core HR, Recruiting, Performance, Learning, Compensation, and Payroll). + Proven success in project management, system upgrades, and cross-functional collaboration. + Experience integrating Workday with ERP (SAP), payroll, and identity management systems. + Workday Pro Certification(s) in one or more modules (HCM, Compensation, Reporting, Integrations) is preferred. + Experience with Workday Extend is desired. + Proficient in Workday Studio, EIB, and Report Writer. + Strong analytical and troubleshooting skills. + Deep understanding of security roles, data governance, and SOX/ GDPR compliance. + Strong problem-solving, documentation, and communication skills. The base salary range for this role is $110,452 to $138,065. 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 ********************************** 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 ********************************************** 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_

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 ********************************** or follow us on LinkedIn. **Job Overview** The **Associate Director, Marketing Analytics - OAB** position will lead business insights for the commercial organization as it relates to the Overactive Bladder therapeutic area. This role will be required to operate with diverse data sources, vendors, stakeholders, in a rapidly changing business environment. This position will report to the **Director, Commercial Analytics - OAB** and will be an integral part of the Commercial Analytics team. This position will partner with marketing, finance, and market access leadership, along with other Commercial Analytics leaders to deliver accurate, timely, and reliable insights to stakeholders across the commercial organization. **Job Duties and Responsibilities** + Perform a critical role in enhancing marketing offerings by developing integrated insights from data/information to shape commercial strategy and decisions. + Partnering with key stakeholders, create and execute annual market research and analytics plans that align to brand strategy and performance measurement needs. + Conduct advanced analytics for brand teams to inform brand planning, promotional resource allocation, and marketing strategies, including patient journey creation and ROI analysis. + As part of the Gemtesa brand planning process, support the development brand-specific situational analysis, participate in tactical planning, and partner with sales and marketing to create meaningful KPIs. + Closely involved with financial planning process, providing key insights and assumptions for annual and long-range plan forecasting in partnership with brand leadership. + Develop compelling and actionable insights presentations for key stakeholders, including brand leadership, cross-functional partners, and senior management while adapting communication style based on audience. + Lead the development of deep dive analytical suite assimilating insights from multiple sources, both internal and external, to help provide a thorough understanding of brand performance. + Develop strategic partnership as the point of contact for Gemtesa brand team. + Develop and prioritize key business questions with the cross-functional support of medical, clinical, brand teams, and other partners in the organization. + Manage development anddelivery of strategic KPIs and supporting metrics for the monthly and quarterly business reviews. + Direct analytic ad hoc project requests related to the Gemtesa brand team. **Key Core Competencies** + Strategic thinker: can see big picture opportunities and translate into actionable plans. + Excellent written and oral communications skills including executive presence in formal stakeholder presentations. + Strong knowledge and experience with pharmaceutical data sources (i.e., IQVIA, SHA, MMIT/DRG formulary / market access data). + Strong knowledge and experience with patient and HCP market research and translating insights from research into actionable recommendations. + Strong understanding of omnichannel data and media promotion measurement (e.g. Crossix, Media Agencies, etc). + Proven success in developing analyses with Business Intelligence tools and methods (e.g., Tableau, Qlikview, SQL). + Excellent team player and collaborative skills. + Strong demonstrated project management skills and managing external vendors/ deliverables within tight timelines. + Strategic partner to multiple cross-functional stakeholders. + Ability to understand the commercial environment and business needs and translate to workable solutions. + Highly motivated change agent that can push against the status quo and seed new ideas, new ways of thinking, and new ways of working. **Education and Experience** + Minimum 8 - 12 (w/o Master's) or 6 - 8 years (with Master's) years of relevant experience in biotech or pharmaceutical industry. + Previous marketing, marketing science, or omnichannel experience preferred. + Previous commercial/ brand analytics experience (with Statistical Packages) preferred (e.g., SAS, R, SPSS, etc). + Patient/consumer and HCP insights and strategy experience. The base salary range for this role is $150,640 to $188,300. 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 ********************************** 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 ********************************************** 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_

Job Description CSafe is seeking a Senior Software Engineer at our World Headquarters, in Monroe, Ohio to join our world class Software Engineering team! You will be the hands-on technical owner for modern, data-aware applications in a Microsoft/Azure environment. You'll set engineering standards, make architectural calls, and ship reliable services by partnering closely with product, design, and third-party build partners while mentoring others as our team grows. You'll set engineering standards, make architectural calls, and ship reliable services by partnering closely with product, design, and third-party build partners while mentoring others as our team grows. You will be reporting directly to the Director of Software Engineering. CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive the medicines and treatments they need. In addition to key acquisitions, CSafe has operations in more than 70 locations worldwide to ensure product availability and continue to fulfil our founders' mission to provide patients around the world with access to viable, life-enhancing pharmaceuticals. With a “client-first” focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading products provides an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases. Our team operates with curiosity, humility, accountability, and entrepreneurial spirit to deliver on our vision and mission. Come join our growing industry and build your career with us! What You'll Do: Own full stack architecture and implementation across modern web apps. Design and develop scalable services and APIs (C#.NET) along with responsive, performant front-end components (React/Next.js, TypeScript). Build secure integrations with internal/external systems (e.g., ERP/CRM), and design for resilience Collaborate with various engineers to deliver incremental value; manage technical backlog and drive continuous improvement Partner with third-party and offshore build teams for knowledge transfer, alignment on delivery, and long-term maintainability What You'll Bring: Degree in Computer Science, Software Engineering, or IT or equivalent work experience 5+ years building production systems in C#/.NET (6/8+) 5+ years building a modern front-end application (React/Angular) Experience developing in a cloud environment (Azure or AWS) Strong API design (REST/JSON), security (OAuth2/OIDC/Entra ID), and automated testing (unit/integration) Proven experience with CI/CD (Azure DevOps or GitHub Actions), infrastructure basics, and cost/perf tuning in cloud environments Proficiency in modern front-end frameworks and technologies, including React (preferred), Angular, TypeScript, HTML5, CSS3, and responsive design principles. Strong understanding of front-end architecture and performance optimization, including state management (Redux, React Query, or equivalent), Extremely organized, detail-orientated and able to work with minimum supervision Event-driven patterns, DDD, feature flags (Launch Darkly), and resiliency engineering is a plus Experience with Terraform/Bicep, AKS, caching, and message-driven integrations is a plus Strong cross functional collaboration Why Join Us: At CSafe, we foster an exciting, collaborative, and inclusive work environment that promotes personal and professional growth. We encourage feedback, foster trust, and support a culture of inclusion where everyone's voice matters. Be Part of a Growing Industry by joining a forward-thinking team in the rapidly expanding temperature-controlled shipping sector. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.