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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Associate Director, ERP Functional & Solution Architect, ICT role will be responsible for overseeing MS D365 Enterprise Resource Planning (ERP) within the organization. Crucial role in implementing ERP specific business process improvements and enhancements within the organization and ensuring the system's optimal performance and functionality. Perform the planning, design, configuration, customization, and implementation of MS D365/ERP modules and functionalities, ensuring seamless integration with existing systems, ensuring compliance with industry standards, security protocols, and regulatory requirements. The ERP Functional Architect, Associate Director, ICT role will also serve as a business process analyst aligned with enterprise (i.e., SCM, MFG, Quality) and Corporate Functions (i.e., Finance, HR, Legal, Compliance, Procurement) ensuring successful technical solution development and delivery.

Essential Functions:

The D365 ERP F&O Functional Architect is responsible for the end-to-end functional design, configuration, and optimization of Microsoft Dynamics 365 Finance & Operations to support business operations across Finance, Procurement, Supply Chain, Manufacturing, Quality, and related business functions. The architect will partner with business stakeholders, technical teams, and implementation partners to ensure that the solution is aligned with corporate strategy, compliant with GxP/GAMP 5 standards (where applicable), and scalable for future business growth.

1. Solution Architecture & Design
•    Lead the functional design and architecture of the D365 F&O solution across key modules (Finance, Supply Chain, Manufacturing, Procurement, Inventory, Quality, etc.).
•    Translate complex business requirements into clear, scalable, and compliant functional solutions.
•    Emphasizes proactive, holistic leadership in solution architecture.
•    Focuses on aligning solutions with business goals, value streams, and enterprise architecture governance.
•    Define data flows, integrations, and system interactions between D365 and other enterprise systems & interfaces (e.g., LIMS, MES, 3PL Partners, External Finance Systems, and Cloud systems).
•    Ensure alignment with Microsoft’s Dynamics 365 roadmap and best practices.

2. Implementation & Configuration
•    Perform and lead the setup, configuration, and deployment of D365 F&O modules. 
•    End to end management of project/solution management by using tools like Azure Boards for planning and tracking work, Azure Repos for code versioning, and Azure Pipelines for automating build and deployment. Perform all activities from initial user stories and tasks to code, testing, and deployment through integrations with tools like Lifecycle Services (LCS). 
•    Drive fit-gap analysis and functional documentation. Develop User/Functional Requirements, Functional/Technical Design, System/Business process architecture diagrams.
•    Collaborate with development/vendor/managed service teams to define functional specifications for enhancements, bug/fix, customizations, reports, and interfaces. Co-develop or individually develop code/configurations required and coordinate internal development and user acceptance testing of the solution.
•    Participate in system validation activities, including IQ/OQ/PQ documentation for regulated environments.

3. Governance & Compliance
•    Ensure the ERP system design complies with GAMP 5, SOX, and GxP regulatory requirements.
•    Develop and maintain master data governance, change management, and configuration control processes.
•    Support audits and inspections through proper documentation and traceability.
•    Develop current and future state roadmaps and architecture.
•    Assess and align system release plan with Microsoft Dynamics 365 roadmap

4. Stakeholder Collaboration
•    Partner with business process owners to define best practices, continuous improvement opportunities, and confirm desired solution to fix the support/bug-fix items raised. Support communities of practice and collaborative development methodology.
•    Work independently to perform required fix within the D365 framework. Test and confirm the developed fix with business process owners. 
•    Work closely with IT, OT, and cloud teams to ensure integrated digital architecture.
•    Provide subject matter expertise and training for internal business process owners and super users.

5. Project & Vendor Management
•    Support ERP implementation and upgrade projects through all phases — initiation, design, testing, go-live, and hypercare.
•    Manage and coordinate external implementation partners and vendors.
•    Define KPIs and monitor system performance, adoption, and ROI.

Requirements:

Education 

Bachelor’s degree or equivalent experience in computer science, information systems, engineering, supply chain, or related fields required. Microsoft D365 F&O Certification preferred.

Experience
•    8+ years of experience implementing or supporting Microsoft Dynamics AX / D365 F&O.
•    Proven expertise across multiple functional domains (Finance, Manufacturing, Supply Chain, Procurement).
•    Experience designing integrations between ERP and external systems (LIMS, MES, Payment interface with Bank, External Finance Systems, etc.).
•    Strong understanding of ERP data models, workflows, and reporting.
•    Strong understanding of functional and solution architecture of, and experience performing code and configuration updates within the following Dynamics 365 modules:
o    Finance: General ledger, Cash and bank management, Accounts payable, Accounts receivable. Budgeting, Fixed assets, Cost accounting, PR/PO process, Vendor Management, Cost Accounting and Management 
o    SCM: Inventory management, Master planning, Procurement and sourcing, Product information management, Production control, Warehouse management, Cost accounting, Cost management, Asset management, including scheduled maintenance and repair tasks 

Technical Skills
•    Proficient in MS Office Suite. Experience with technology delivery applications across solutions such as (ERP, Manufacturing Execution Systems, Finance Systems, Control Tower). 
•    Microsoft Certified: Dynamics 365: Finance and Operations Apps Solution Architect Expert certification preferred.
•    Experience with emerging technologies (AI/ML, cloud, etc.) as relevant to ERP.

Working Conditions:

Requires up to 10 % domestic and international travel

The anticipated salary for this position will be $165,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Director, GRA Compliance and Training Team Lead, provides strategic leadership for the GRA Compliance & Training function, defining vision, priorities, and resource allocation to support organizational objectives. This role leads and develops a high-performing team, oversees global compliance frameworks, SOP governance, inspection readiness, and regulatory risk management. The Director drives the global training strategy, optimizes SOP processes, and collaborates cross-functionally to ensure consistent, integrated compliance standards. Key responsibilities include monitoring compliance and training KPIs, ensuring audit readiness, managing change initiatives, and fostering a risk-aware culture across GRA.

Essential Functions:

•    Lead the GRA Compliance & Training team, setting vision, priorities, and resource allocation aligned with corporate and GRA objectives. Mentor and develop team members, fostering accountability, excellence, and a risk-aware culture.
•    Develop, implement, and maintain global compliance frameworks to ensure adherence to international laws, regulations, and corporate standards.
•    Oversee the GRA risk register, identify and mitigate compliance risks, and support timely corrective actions.
•    Manage global SOP/WI governance, ensuring harmonization across regions, optimization of processes, and adherence to local requirements. Author, review, and approve SOPs/WIs as needed.
•    Lead readiness for regulatory inspections and internal audits, maintaining robust documentation and serving as RA support or lead for GxP inspections/audits when required.
•    Oversee compliance and role-specific training programs for all GRA staff, balancing short-term training needs with long-term career development initiatives.
•    Define, track, and report compliance and training KPIs to senior leadership and governance committees; escalate risks and issues appropriately.
•    Collaborate with QA, PV, IT, and other functions to ensure integrated compliance and training standards, knowledge sharing, and alignment of best practices.
•    Manage compliance-related change initiatives, including adoption of new systems, tools, and processes.
•    Ensure projects and products with external partners/vendors comply with relevant regulations and corporate standards, including selection and onboarding where applicable.
•    Identify and lead operational or strategic improvements to enhance compliance and training effectiveness.
•    Monitor and assess changes in regulations, industry trends, and competitive intelligence, and provide guidance on organizational impact.
•    Maintain robust documentation to support audit readiness and compliance evidence.
•    Support the management of the GRA Compliance & Training budget, ensuring effective resource allocation.
•    Participate in the selection and onboarding of GRA staff as needed to build a high-performing team.
•    Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles and GRA Vision.

Requirements:

Education

Bachelor’s degree in life sciences, pharmacy, medicine, or closely related scientific discipline. Advanced degree (MS, MBA, or PhD) preferred. Relevant professional certifications in Regulatory Affairs or Compliance (e.g., RAC, CCEP) are a plus.

Experience

•    Minimum eight (8) years of progressive experience in regulatory compliance, training, or quality within the life sciences, pharmaceutical, or biotech industry.
•    Proven experience leading global teams and managing cross-functional projects.
•    Demonstrated track record in developing and implementing compliance frameworks and risk management programs.
•    Oversaw regulatory inspections, audits, and ensuring inspection readiness.
•    Hands-on experience with SOP governance, process optimization, and training program development.
•    Collaborated with internal and external stakeholders, including partners, vendors, and regulatory authorities.
•    Championed change initiatives and implement compliance systems or tools.

Technical Skills

•    Strong knowledge of global regulatory requirements (FDA, EMA, ICH, GxP standards).
•    Expertise in compliance monitoring, risk assessment, and audit readiness processes.
•    Proficiency in training program development and learning management systems.
•    Familiarity with SOP/WI management, document control systems, and regulatory submissions.
•    Advanced analytical and problem-solving skills with data-driven decision-making.
•    Excellent communication, presentation, and stakeholder management skills.
•    Strong project management skills, including resource planning, budgeting, and performance monitoring.
•    Strong proficiency MS Office Suite.

The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will independently review, approve, and monitor product advertising and promotional labeling material for an assigned product to ensure compliance with US regulatory requirements.  In addition, the associate director will be responsible for supporting preparation of FDA Form 2253 submissions and any requests for advisory comment submissions to FDA's Office of Prescription Drug Promotion (OPDP) as well as submissions to PAAB for promotional materials in Canada, as applicable.

Essential Functions:

•    The Associate Director is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications as well as pipeline and non-promotional communications. 
•    Provides guidance and input for assigned development products reflective of promotional considerations, including assessment of potential labeling claims.
•    Serves as Promotional Review Committee (PRC) chair and as the primary regulatory reviewer of advertising, promotions, and other related materials for assigned product to ensure compliance with applicable FDA/Health Canada laws, regulations, and guidance.  
•    Works collaboratively with cross-functional partners, including Legal and Medical as part of PRC. Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating, and managing business risks.  
•    Serves as the regulatory reviewer for the Medical Review Process (MRC) for assigned product(s).
•    Provides direction and works collaboratively to ensure that changes in US Prescribing Information and Canadian Product Monograph are reflected in current promotions and advertising
•    Continually assesses the advertising and promotion related
process to enhance efficiencies and compliance. 
•    Collaborates in cross-functional efforts to develop, update, and implement policies, procedures and guidelines related to Regulatory Advertising and Promotion Compliance.
•    Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products.
•    Monitors US and Canadian regulatory promotional environment and stays abreast of all relevant regulatory and industry changes and updates related to FDA and Health Canada guidance, warning letters, enforcement actions and regulations; and communicate to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes
•    Ensures the maintenance of paper and electronic records of all submissions and communications with OPDP, and any supporting documentation
•    Provide relevant regulatory compliance training to staff and cross-functional partners from a regulatory perspective.

Requirements:

Education
Bachelor’s degree in life science or closely related discipline. Advance degree preferred (Pharm.D., Phd, M.S, JD)

Experience
•    Minimum seven (7) years of progressive experience in the pharmaceutical or biotechnology industry, specifically in Regulatory Affairs with a focus on Advertising and Promotion (Ad/Promo).
•    Proven track record as the primary regulatory reviewer for promotional and non-promotional materials across various therapeutic areas, ensuring compliance with FDA regulations, industry guidelines (e.g., OPDP, PhRMA), and internal policies.
•    Strong experience in leading and managing Regulatory review processes within cross-functional Medical, Legal, and Regulatory (MLR) teams for both consumer and professional marketing materials.
•    Familiarity with launch planning, including pre-approval communications, disease awareness campaigns, and launch materials. 
•    Experience with training Commercial and cross-functional teams on promotional compliance principles, regulatory changes, and industry best practices.
•    Preferred, but not required, experience with reviewing promotional and non-promotional communications in Canada to be compliant with Health Canada regulations.

Technical Skills
•    Thorough knowledge of applicable regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments in the US
•    Understanding of clinical study design and statistical analyses in assessment of promotional claims
•    Excellent written, verbal, and presentation skills, with the ability to communicate effectively across all levels of the organization.
•    Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.
•    Experience with Veeva, SharePoint and Box

Working Conditions:

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $____ to $____.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Veeva Vault Architect serves as the technical and strategic leader for designing, implementing and optimizing Veeva Vault solutions across the global organization.  This role ensures that all Vault applications align with business objectives, regulatory requirements, and enterprise architecture standards.  The architect collaborates closely with business stakeholders, IT teams and implementation / support partners to deliver scalable, compliant and high performing Vault-based solutions.

Essential Functions:

Solution Architecture & Design
•    Develop end to end architecture for Veeva Vault applications (e.g., Quality, RIM, Medical, Commercial).
•    Interpret business requirements into scalable, secure and compliant Vault configurations.
•    Define data models, object structures, workflows, lifecycle states and security models.
•    Establish integration patterns between Vault and other enterprise systems (ERP, LMS, MDM, LIMS, etc.).
•    Create architectural standards, design documents and technical specifications.

Platform Leadership
•    Serve as the subject matter expert for Veeva Vault capabilities, limitations and best practices.
•    Guide configuration teams on Vault objects, metadata, workflows and automation.
•    Familiarity with domain level configuration and best practices.
•    Evaluate new Vault features and releases, advising on adoption and impact.
•    Ensure alignment with GxP, 21 CFR Part 11, Annex 11, and other regulatory frameworks.

Implementation & Delivery
•    Lead technical workstreams during Vault implementations, migrations and enhancements.
•    Oversee data migration strategies, mapping, cleansing and validation.
•    Support test planning, execution, and defect resolution for configuration and integrations.
•    Partner with project managers to ensure delivery timelines and quality standards are met.

Integration & Data Management
•    Architect and oversee integrations using native Veeva Vault Integrations, Veeva APIs, Vault Loader and middleware tools across both Vault and other applications.
•    Ensure adherence to data governance, master data strategies and cross system data flows.
•    Ensure data integrity, auditability, and traceability across the Vault ecosystem.

Stakeholder Collaboration
•    Work with business process owners to understand needs and translate them into technical solutions.
•    Collaborate with QA/SA, Compliance, Data Privacy and Validation teams to ensure system readiness.
•    Provide technical guidance to internal teams and external implementation partners.

Operational Excellence
•    Establish monitoring, performance optimization and support frameworks.
•    Develop documentation, SOPs and knowledge transfer materials.
•    Support ongoing enhancements, change requests and continuous improvement initiatives.

Requirements:

Education

Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required. Veeva Vault certification(s) preferred.

Technical Skills
•    8+ years of experience in the configuration, implementation, support and operations of Veeva Vault-based solutions.
•    Proven expertise across multiple functional domains (Quality, Regulatory, Medical, Commercial and/or Clinical).
•    Hands-on experience with Veeva APIs, integration patterns and data migration tools.
•    Knowledge of GxP compliance, validation practices and regulated system requirements.
•    Experience with large-scale, global implementations.
•    Experience with middleware platforms (e.g., MuleSoft, Informatica), Master Data Management concepts and solutions preferred.

Working Conditions:

Requires up to 10 % domestic and international travel.

Willingness to work in a global environment with the ability to adapt to diverse cultural norms, including different communication styles, time zones, holiday schedules, and management approaches.

The anticipated salary for this position will be $185,000 to $200,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Specialist, Bioanalytical, Translational Research supports multiple pharmaceutical development programs by managing clinical sample use and disposition for biomarker testing, coordinating with external vendors, and providing data analysis support to biomarker teams. This role also facilitates collaboration with project teams and contributes to related clinical trial activities as needed.

Essential Functions:

•    Implement and coordinate with other functional areas to institute processes for clinical sample management, from informed consent to data generation, including biobanking processes.
•    Support biomarker teams in managing biomarker activities, such as organizing and analysis of biomarker data, conducting biomarker data verification and quality control, etc.  
•    Assist in coordinating and overseeing vendors for biomarker and bioanalytical assays, including selection, contracting, performance monitoring, and collaboration with colleagues across regions (e.g., Japan) and functions (Clinical Operations, Biometrics, Medical Sciences). Represent Translational Research on study teams.
•    Maintain and keep bioanalytical assay and clinical study-related files and documents organized and archived in the trial master file (TMF).
•    Ensure regulatory and procedural compliance by following applicable standards, guidelines, and regulations for patient sample handling and biomarker data management.
•    Contribute to process improvement and innovation by developing optimized methods for sample handling, data management, and integration of results into the design of new clinical studies. 
•    Develop and maintain SOPs and related documents (manuals, work instructions) for sample acquisition, handling, and use.
•    Collaborate across functions to support departmental and company goals, including contributions to study action plans and broader program objectives.

Requirements:

Education: 
Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Pharmacology or closely related discipline. Masters degree a plus.

Experience: 
•    Minimum 2 years of experience in bioanalytical, translational research, or clinical research settings, preferably in the pharmaceutical or biotechnology industry.
•    Exposure to handling and processing clinical samples, including sample tracking and storage.
•    Hands-on experience with biomarker assays, data analysis, or quality control activities.
•    Participation in cross-functional project teams or collaborative research initiatives.
•    Experience interacting with external vendors or laboratory partners is a plus.

Technical Skills
•    Knowledge of bioanalytical and biomarker assay principles, sample handling, and biobanking processes.
•    Familiarity with clinical sample documentation and regulatory requirements (e.g., GCP, SOPs, TMF).
•    Proficiency in basic data analysis and reporting using standard software tools (e.g., Excel, GraphPad, or equivalent).
•    Strong organizational skills with the ability to track multiple samples, datasets, and projects.
•    Effective written and verbal communication skills for scientific documentation and cross-functional collaboration.
•    Ability to follow protocols, standard operating procedures, and quality guidelines with attention to detail.
•    Familiarity with scientific analytical software (JMP, R, Etc)
•    Proficient in MS Office Suite 

Working Conditions:

Requires up to 5% domestic and international travel

The anticipated salary for this position will be $90,000 to $105,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary of Job

The territory covers - MN/WI/IA/MO/AR/MS

 The Clinical Educator is required to exemplify strong disease state and treatment subject matter expertise and support to members of the Patient Services team. The Clinical Educator will be responsible for educating patients, family members, caregivers and HCPs, on certain disease states and treatments in a certain regional territory in the US.

The Clinical Educator will drive team territory business objectives and plans and deliver field excellence. The Clinical Educator will be responsible for a high standard of performance and compliant behavior. They will be expected to support the overall Patient Services strategy, policy and guidance development, marketing, and technology enhancements by acting as a subject matter expert in Clinical Education, with a strong background in Patient Services. Strong working knowledge of industry trends and requirements is necessary. This is a cross functional role and will collaborate with other functions to understand patient and customer needs and implement activities that align with Company strategy and comply with current regulatory and healthcare compliance guidelines.

The primary role the Clinical Educators is the delivery of on label, company approved clinical education programs to patients, families, and HCPs (RNs, NPs, PAs). The individual in this position will be responsible for a specific geographic area with the ability to travel between 50% and 75% of the time. The Clinical Educator will report to the Director of Clinical Education.

Essential Functions

• Provide company approved education on disease state and on-label product and treatment education to patients, families, patient organizations, and community groups, ensuring safe and effective use of KKUS products
• Deliver company approved, on label unbranded and branded presentations to HCPs to educate on disease state and KKUS product(s)
• Collaborate with other functions within the organization to understand patient and customer needs and identify, develop and implement educational activities that align with Company strategy and comply with current regulatory and healthcare compliance guidelines
• Deliver on established program metrics, key performance indicators, and performance measurements.
• Participate in PRC (Medical/Legal/Regulatory) review process as needed as a Clinical Education subject matter expert
• Collaborate with the training and operations verticals to develop and maintain all Clinical Education Program SOPs, Workflows, Communication Guides/Templates, Training and Reports
• Serve as liaison between other functions within the organization to ensure appropriate open communication of Company information
• Work with internal and external Patient Services partners (Hub, SPs, etc.) to ensure seamless patient experience on necessary customer touchpoints
• Maintain disease state understanding through continuing medical education by attending conferences and other educational opportunities
• Develop and maintain KKUS product expertise and understanding

Education

• Bachelor of Science in Nursing (BSN) degree or bachelor’s degree in the health care field; advanced degree preferred (MSN, NP, PA)

Experience

• Minimum three to five years of experience in the clinical setting, healthcare education, and/or medical industry.
• Rare disease experience preferred, metabolic bone disease experience preferred, along with expertise in community outreach work.
• 2+ years of pharmaceutical or biotech industry experience, preferred
• Expert knowledge of Clinical Education Solutions, including field CE, and patient support program strategy, operational processes, technology, and data
• Sufficiently experienced in working with vendors and cross functional partners; manage conflicts appropriately
• Home infusion and/or Infusion Center experience or knowledge
• Demonstrated ability to develop deep, effective working rapport to foster collaboration, and consultative relationships with healthcare professionals, patients, and caregivers, as well as internal matrix team
• Demonstrated ability to develop effective collaborative relationships within cross-functional teams
• Analytical and problem-solving capability, along with the ability to work independently
• Excellent English oral and written communication and presentation skills.
• Superior organizational and time management skills
• Desire to innovate and work in a fast-paced, energetic environment
• Ability to travel up between 50% and 75%

Technical Skills

• Proficient in MS Office Suite.

Non-Technical Skills

• Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization

Travel

Requires up to 75% domestic and international travel

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center, Suite 6, Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. 

The anticipated salary for this position will be $150,000 to $170,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

Kyowa Kirin provides a comprehensive compensation and benefits package which includes:

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, and Health Savings Account, Business Travel Insurance, Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match and annual discretionary profit sharing
• Well-Being and Work-Life Programs Including Gympass, Nutrition Counseling, , Volunteer Time Off, Flexible Work Arrangements, Parental Leave, Adoption Assistance, and TouchCare Insurance & Billing Support
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Perks and Discounts with Tickets at Work and LifeMart
• Reward & Recognition Programs
• Career Development and Training 

#LI-PE1 

#Field

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

The CSV Engineer will support all CSV Commissioning, Qualification and Verification activities for the NC Manufacturing Facility. The initial area of focus for this role will initially be in the analytical space, supporting a LIMS implementation, and the associated instrument and ancillary system integrations. Post project implementation, the Engineer will be responsible for supporting all EQV/CSV activities at the site as it transitions into routine operations.
As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

This role reports into the Associate Director, CQV Site Lead

Technical Skills, Knowledge, and Experience 
•    Executes the ongoing development and maintenance of the EQV/CSV/CSA/DI program for the Sanford site.
•    Executes the implementation and qualification of selected analytical system solutions and integrations.
•    Lead EQV/CSV/CSA/DI programs for various initiatives including: capital projects, site changes, technological implementations. etc.; ensuring alignment with site and global computer system validation requirements and industry practices to maintain a compliant facility.”
•    Drives CSV and integrations associated with:
o    LIMSs
o    Veeva
o    D365
o    MES / PCS / BMS / DHist
o    ValGenesis
o    Cloud
o    IT/OT
•    Once the site becomes operational, lead ongoing maintenance and continuous improvement of all qualified automation and computerized systems, ensuring continued compliance with cGMP standards, regulatory requirements, and company procedures.

Individual contributor with the opportunity to potentially lead or coordinate task teams.

Education and Experience
•    The following combination of education and professional experience is required for this role:
o    Bachelor’s degree in a technical field with at least 3 years of experience in CQV for BioPharma Manufacturing or Capital Projects.
o    Associate’s degree in a technical field with at least 4 years of experience in CQV for BioPharma Manufacturing or Capital Projects.
o    High School degree may be considered with at least 6 years of CQV direct related experience in BioPharma Manufacturing and/or Capital Projects.
•    Formal GMP and Safety training is essential.
•    Experience with Tech Transfer is a plus. Background in cGMP regulations, GAMP, EHS.
•    Experience operating within a start-up biopharma manufacturing facility is a plus.

Technical Skills
•    Proficient in MS Office Suite
•    Familiar with Azzure Cloud, POMSnet Aquila MES / Ignition PCS / Ignition EMS / Schneider EcoStruxure Building Operation BMS / DeltaV / Canary Axiom Data Historian / PLCs
•    Strong analytical skills to identify business requirements and to provide solutions to complex issues.
•    Strong working knowledge of regulations for computerized systems, data integrity (e.g.,
21CFRPart 11, EU Annex 11, FDA/PICS Data Integrity Guidance, GAMP5)
•    Demonstrated knowledge of CSV/CSA applications and regulations

Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.

Initially, position requires working on a construction site and will ultimately transition to the biotech manufacturing site in Sanford, NC.

Work is 100% on-site.  This is not a hybrid or remote role.  

Requires up to 10% domestic and limited international travel 

The anticipated salary for this position will be $90,500 to $114,300.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-SH1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Director, Drug Safety Physician is the Lead of the Global Safety Team(s) to develop safety strategies to ensure patient safety and regulatory compliance for products that are in development and / or marketed. The Director, Drug Safety Physician is responsible for medical analysis of safety data, validation and confirmation of safety signals, and implementation of processes for communication and management of emerging signals and safety data to internal and external stakeholders. The Director, Drug Safety Physician, contributes to the constant improvement of the Kyowa Kirin Pharmacovigilance System to ensure the global PV strategy is in alignment with regulatory requirements and business needs.

Essential Functions:

Ensure high quality, accurate, timely medical contributions to the safety evaluation of Kyowa Kirin products by leading Global Safety Team(s) to:
•    Ensure the safe development of new products and contributions of safety are delivered in a timely and effective manner to Development teams including the identification and implementation of safety strategies to deliver Company targets for products in both development and the market.
•    Determine the safety strategy for the preparation of global regulatory submissions for Marketing Authorization approvals (e.g. North America, EMEA/ ROW, Japan and Asia Pacific) and ensure the delivery of high-quality safety documentation for those submissions.
•    Lead/ develop strategies for safety-related regulatory activities and support interpretation and authoring (in collaboration with the PV Scientist) of safety sections of documents including protocols, ICFs, IBs, clinical study reports (CSRs), Company Core Safety Information (CCSI), DSURs, PSUR, PBER, PADERRMP, REMS, Data Monitoring Committees reports, etc.
•    Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products and provide appropriate support for implementation of the associated conclusions.
•    Develop proactive risk management strategies for marketed and / or investigational compounds ensuring that these are contained and implemented in appropriate strategies including Risk Management Plans. Ensure success of such activities by close liaison with cross- functional Global Development, Franchise, and labeling Teams.
•    Lead signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment reports, support of Company Core Data Sheets and other similar reports and actions.
•    Provide medical review and interpretation of safety data for preparation of aggregate reports and ensure consistent messaging across all such reports and documents issued for both development and post-marketing purposes.
•    Contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of Kyowa Kirin products, safety issue work up etc.
•    Ensure that updated safety profiles of Kyowa Kirin products are provided to senior management as required.
•    Represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be, or may be, discussed and lead presentation of the Global Safety Team’s recommendations on safety issues to cross- functional decision-making bodies and Teams (e.g. global PV Committee, R&D Committee, Evidence Generation Committee, Label Committee, Global Development Teams, Franchise Teams, etc).
•    Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department.
•    Participate, when requested, in due diligence ensuring clear recommendations for progression to agreement.
•    Ensure that Ethics and Medical Compliance is applied within all pharmacovigilance activities.
•    To work cross functionally within project teams to meet Company objectives and to represent the Department of Pharmacovigilance in a team-oriented manner and delivering quality and timely input to meet the needs of the project team.
•    Any other activity that may reasonably be required.

Requirements:

Education
Medically qualified physician with post‑registration clinical experience. Completed specialist training and/or clinical exposure in immunology and/or haemato‑oncology is strongly preferred.

Experience
Minimum of eight (8) years’ experience in pharmacovigilance or a related area of clinical development in biotechnology or pharmaceutical industry. Demonstrated in-depth knowledge of regulatory requirements global pharmacovigilance regulatory requirements, including both pre-approval and post-marketing environments

Technical Skills
Proficient in MS Office Suite. Experience in the use and management of Drug Safety Databases and MedDRA coding.

Working Conditions

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $250,000 to $275,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary of Job

 As a key member of the Patient Services team, the Director, Field Patient Access Solutions is responsible for leading patient services field strategy and teams as well as for the field strategy and operations components of Kyowa Kirin’s Patient Support Programs for all products, focused on reimbursement, patient access, and initiation. This individual will be responsible for ensuring that all program operations are in line with relevant laws, regulations, and Company Policies including HIPAA and Patient Privacy guidelines. Overseeing the day-to-day operations of the Patient Services’ field teams and vendors, this key contributor is expected to ensure an efficient, timely, and compliant patient and customer experience with Kyowa Kirin’s products. This individual will be an expert in Kyowa Kirin’s Patient Support processes and ensure that patients and customers receive the highest level of service. They will ensure the internal and external teams are appropriately helping patients start and stay on prescribed medicines. The Director is required to exemplify strong leadership skills and provide adequate coaching and support to members of the Patient Services Field teams. They will be responsible for the hiring and oversight of the Patient Services field teams, including Field Reimbursement Managers (FRMs), and support the vendor selection process for additional field teams, as necessary. The Director will drive team business objectives and plans, enable field excellence, and empower cross-collaborative relationships. In addition, the Director, Field Patient Access Solutions will be responsible for establishing processes to monitor the performance of Patient Services vendors and partners. They will be expected to support program strategy, policy development, marketing, and technology enhancements acting as a subject matter expert in Patient Services and Reimbursement processes and procedures. Strong working knowledge of industry trends and requirements is necessary. They will work closely with the broader commercial teams to understand patient and customer needs and implement appropriate strategies across partners.

Essential Functions

• Patient Service’s lead and subject matter expert on Kyowa Kirin’s products’ payer landscape; responsible for related Patient Services training, education and resource development.
• Work with internal partners to build strategic patient access and reimbursement account plans that align with franchise, market access, and patient services business objectives provide insights and updates accordingly.
• Proactive anticipation of potential reimbursement issues and address via program strategy, process, or procedure updates
• Collaborate with marketing partners and agencies to develop access-related materials and resources.
• Key contributor expansion of internal Patient Services organization, including policy, technology, and organizational structure development.
• In collaboration with key team members, establish program metrics, key performance indicators, performance measurements, and incentive compensation model.
• Manage day-to-day patient access and support services including internal team member(s), field nurse vendors, other field partners; attend field calls with the team
• regularly to provide support and coaching opportunities.
• Responsible for integration of Patient Services teams and procedures into greater franchise processes and objectives
• Enhance the patient and customer experience via feedback, business insights, benchmarking, auditing, and active team monitoring.
• Participate in LMR (Legal/Medical/Regulatory) review process as Reimbursement and Patient Services subject matter expert
• Monitor and analyze data collection from partners; provide data updates and appropriate information to internal and external stakeholders.
• Executes on business objectives related to Patient Services with operational excellence.
• Develop and maintain all Field Access Solutions Program SOPs, Work Flows, Communication Guides/Templates, Training and Reports.
• Manage external partner and internal team performance against contractual arrangements, SOPs, and KPIs.
• Responsible for performance, development, and satisfaction of internal Patient Services Field Team members.
• Works closely with broader home office and field teams to facilitate seamless communication of Patient Services information and updates.
• Partners with Training team to develop necessary Patient Services training for internal and external teams
• Continuously evaluate platforms, processes, and data and implements improvements as needed.
• Work with internal and external Patient Services partners
• (Hub, PAP, co-pay, SPs, etc.) to ensure seamless patient experience on escalated cases.

Education

• Bachelor degree 

Experience

• 10+ years of experience in Market Access/Patient Services in the biotech/pharmaceutical industry required.
• 4+ years of experience leading a specialty/rare field reimbursement or patient access team is required
• Experience working with Specialty products required. Experience in Rare Disease required.
• Expert knowledge of Field Access Solutions, including field reimbursement managers, nursing support, and patient support program strategy, operational processes, technology, and data.
• Sufficiently experienced in team leadership and vendor management skills; can persuade and influence others; manage conflicts appropriately.
• Detailed understanding of Patient Services regulatory and compliance landscape and requirements.
• Experience in audit circumstances and knowledge of investigative processes.
• Detailed understanding of payer landscape, all product types (retail, specialty, buy-and-bill). Ability to build organization personnel structure.
• Demonstrated ability to effectively recruit, develop and retain top talent.
• Excellent tactical and operational execution skills.
• Product launch experience preferred.
• Proven ability to identify,develop, implement and execute operational efficiencies in process and procedures.
• Strong collaboration skills across internal and external stakeholders to drive brand vision through tactical patient services strategy and process.
• Patient-focused.
• Creative problem solver
• In-depth knowledge and understanding of specialty channel patient-level data.
• Experience with data analysis and evaluation required.
• Proven ability to drive operational growth and meet key standard performance objectives.
• Strong business acumen.
• Fluent understanding of reimbursement process terminology required

Technical Skills

• Proficient in MS Office Suite.

Non-Technical Skills

• Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization

Travel

Requires up to 50% domestic and international travel

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center, Suite 6, Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. 

The anticipated salary for this position will be $220,000 to $250,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

Kyowa Kirin provides a comprehensive compensation and benefits package which includes:

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, and Health Savings Account, Business Travel Insurance, Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match 
• Well-Being and Work-Life Programs Including Gympass, Nutrition Counseling, , Volunteer Time Off, Flexible Work Arrangements, Parental Leave, Adoption Assistance, and TouchCare Insurance & Billing Support
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Perks and Discounts with Tickets at Work and LifeMart
• Reward & Recognition Programs
• Career Development and Training 

.

#LI-PE1 

#Hybrid

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Director of Pharmacometrics will lead a team of Pharmacometricians within the Global Development Organization (GDO) and Clinical Pharmacology (CP) function. The role is intended to have a balance of direct project related activities and to support team members in the development and execution of model informed drug development (MIDD) strategies. The Director of Pharmacometrics will support continued development of appropriate workflows and systems to provide quantitative clinical pharmacology deliverables. The Director of Pharmacometrics will help develop all GDO CP members on communication of MIDD strategies and approaches to project teams. The Director of Pharmacometrics will serve to communicate with and educate leadership across the GDO organization, including those in other GDO Functions, on the value of MIDD and quantitative clinical pharmacology strategies. The Director of Pharmacometrics will also look for innovative ways to work with Kyowa Kirin organizations outside of GDO, including but not limited to Regulatory Affairs and Medical Affairs, to increase MIDD strategies throughout development and in post-marketing space.

Essential Functions:

•    Accountable for pharmacometrics deliverables supporting project teams, ensuring scientific quality, timeliness, and impact; identify and drive opportunities to advance quantitative clinical pharmacology across the organization.
•    Guide pharmacometrics strategy and ensure high-quality preparation of pharmacometric components for scientific reports, regulatory submissions, and responses to health authority inquiries.
•    Provide scientific and technical leadership to pharmacometrics staff, ensuring excellence in modeling approaches and effective communication at all organizational levels.
•    Support clear and impactful communication of pharmacometric and clinical pharmacology results to diverse internal and external audiences.
•    Collaborate with GDO Clinical Pharmacology colleagues and cross-functional partners to improve efficiency, alignment, and innovation across drug development initiatives.
•    Advance Model-Informed Drug Development (MIDD) standards by incorporating best practices from the scientific community to continuously improve workflows, processes, and analytical rigor.
•    Establish and implement workflows, tools, and training programs, leveraging internal and external resources to strengthen pharmacometrics capabilities within GDO Clinical Pharmacology, with particular focus on developing Pharmacometrics Leads.
•    Develop and maintain a network of preferred external pharmacometrics experts to support advanced or specialized analyses as needed.
•    Promote scientific visibility through conference presentations and peer-reviewed publications, ensuring dissemination of insights and research outcomes to the broader scientific community.

Requirements:

Education
PhD preferred with specialty training in Pharmacometrics, appropriate MS or PharmD also applicable

Experience
•    Minimum 10 years of pharmaceutical industry experience gained in pharmacometrics / quantitative clinical pharmacology is required. 
•    The understanding and ability to communicate and apply MIDD strategies to drug development. 
•    Understanding of pharmacometrics contributions for successful clinical development of small molecules, biologics, and alternative therapies.
•    Experience in the successful use of MIDD to support drug development decision making
•    Ability to conduct hands-on modeling and simulation using appropriate quantitative tools in a regulated drug development environment, considered expert in field 
•    Experience in the preparation of strategic regulatory documents including reports, summary documents, and response to information requests.
•    Leadership of a team with various backgrounds and skills in pharmacometrics.
•    Experience of developing individuals pharmacometric and communication skills and talents  

Technical Skills
Proficient in MS Office Suite.
Demonstrated proficiency with pharmacometric software tools for non-linear mixed effects modeling, data manipulation, physiologically based pharmacology, and systems pharmacology modeling, such as: Julia/Pumas app, R-studio, NONMEM.

The anticipated salary for this position will be $230,000 to $250,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Discretionary Profit Share
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton