Astellas Pharma jobs in Westborough, MA - 96 jobs

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a Senior Research Associate opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: We are looking for a highly motivated individual to join our Process Readiness (PR) team to contribute to the development of cell therapy products. A successful candidate will design and execute studies that identify critical process parameters or justify manufacturing processes designed to improve product performance and/or yield. This position involves close collaboration with colleagues across different departments of AIRM. Essential Job Responsibilities: Work closely with other Process Readiness (PR) team members, conduct laboratory experiments, tabulate results, and assist in writing development & tech transfer reports Responsible for cell culture of various cell lines including pluripotent cells using specified protocols Assist in the development of new cell therapy processes, including the introduction of new materials, equipment, and operations Assist in establishing process parameters and improving manufacturing efficiencies Assist in cellular and molecular assay development and execution Maintains accurate records such as notebooks, batch records and electronic entries Assist in lab material inventory and lab operation Contributes to preparation of technical reports and result summaries Prepare and/or review study reports, present results to small and large groups

A global pharmaceutical company is seeking a Medical Science Liaison to build relationships with healthcare professionals and provide scientific support in Massachusetts. This role requires a PharmD, MD, or equivalent, along with 1+ years of relevant experience, preferably in oncology. Candidates must possess strong communication and relationship-building skills. Compensation ranges from $150,800 to $226,200, and a valid driver's license is required for travel. #J-18808-Ljbffr

**Join a Legacy of Innovation 125 Years and Counting!**Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: ME, NH, VT, NY, CT, RI, MA **Responsibilities:**Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: * Presenting disease state and Daiichi Sankyo product specific data to HCPs* Responding to unsolicited requests for medical information* Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards* Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making* Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders* Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships* Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies* Completes administrative duties, including monthly expense reporting and field activity reporting* Represents the Medical Science Liaison function by participating in DSI meetings, functions, events**Additional duties and responsibilities are based on position level/title, and may include but are not limited to:*** Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives.* Ability to anticipate trends and capitalize on opportunities* Lead special projects/initiatives.* Assist in the development of team members* Represent FMA leadership at DSI meetings, functions and events**Qualifications:** Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.***Education Qualifications (from an accredited college or university):**** PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience preferred***Experience Qualifications:*****MSL/Sr. MSL*** 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred* Previous experience in Oncology, clinical research and medical education preferred**Principal MSL/Associate Director MSL*** 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred* Previous experience in Oncology, clinical research and medical education preferred***Additional Qualifications:**** Must have a valid driver's license with a driving record that meets company requirements* Ability to travel up to 60%**Compensation and seniority level/title based on experience and qualifications.** *Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.***Salary Range:**$150,800.00 - $226,200.00**Job Summary:**At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc. #J-18808-Ljbffr

Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary exists the Global Clinical Development (GCD) department. OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka's global health-care products. The Global Clinical Development Program Leader is responsible for leading the end-to-end strategy, and development and delivery of a portfolio of novel serotonergic agonists (NSA). Shaping and executing late-stage clinical development strategies for the NSA portfolio of therapeutic assets, ensuring programs progress efficiently toward registration and commercialization. This role serves as the primary and single point of contact for internal and external stakeholders, ensuring seamless integration, governance, and lifecycle management from early-stage development through submission to global health authorities. This role provides scientific, clinical, and strategic leadership across Phase II/III program design, evidence-generation plans, regulatory interactions, and cross-functional integration to support differentiated therapeutic value and patient outcomes. In addition to overseeing clinical development, the leader will play a central role in creating a unique, patient-centered go-to-market strategy tailored to the emerging psychedelic medicines landscape. This includes orchestrating health economics and outcomes research, defining care-delivery models, navigating reimbursement and market access pathways, and partnering with commercial, medical affairs, and external stakeholders to build scalable, ethically grounded treatment ecosystems. **** The specific duties assigned to the Executive Director; Global Clinical Development Program Lead will include the following: **Key Role Accountabilities:** Summary of Global Clinical Development Program Lead for the NSA Portfolio include: + Establish & continually evolve global portfolio strategy indications/sequencing. Align with Product Development Committee (PDC) and the Early Development Team (EDT) based on internal strategy and competitive landscape + Recommend individual asset strategies that supports a differentiated product profile including proposed go/no-go criteria (early to late phase) + Broader portfolio evidence generation strategy + Align COA endpoint development and validation work across individual assets + Drive portfolio-wide stakeholder strategy through external landscape & policy shaping (GA, PASM, GMA, GRA, Corporate Comms) and identify synergies with the broader CNS portfolio + Drive internal and external communication strategy + Develop and continually evolve differentiated global go-to-market strategy based on unique attributes of assets within the portfolio: + Reimbursement and coding coverage + Broader portfolio global commercialization assessment/planning to drive asset's global CDP + Patient support/wrap around services + Provide overall portfolio asset prioritization and support for discovery programs and indication selection + Set overarching regulatory strategy and endorse individual asset strategies as needed + Endorse proposed go/no-go criteria and support PDC for action points and EDTs for governance engagement for portfolio assets + Endorse CDPs for discovery/early stage and late-stage programs + Portfolio KOL engagement & patient advocacy strategy **Strategy & Execution** + Serve as the primary point of contact for key partners, ensuring collaborative and productive relationships. + Drives the asset's initial indication development strategy, including scientific, regulatory, and clinical access. + Drives asset/brand vision and strategy through all lifecycle development activities, including registrational studies, as well as post-marketing studies + Shapes products for competitive profile that achieves pricing, reimbursement, access and penetration by developing target product profile, developing initial indication label in-line with target profile, and creating economic value dossier + Oversees and adheres to the governance processes for the selected asset and drives the achievement of key milestones + Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other team members, and to external regulatory agencies. + Constantly seeks innovative ways to grow the value of the asset throughout the product lifecycle by leveraging the team's experience and skillset. + Co-leads regulatory filing activities through NDA. Provides strategic direction to ensure concise, clear and convincing argumentation in all written and verbal communications. + Recommends Business Development activities necessary for optimization of the portfolio value i.e., provide development perspective during due diligence or recommend opportunities that can help further support the specific portfolio group of assets **Leadership & Matrix Management** + Sets vision for the Product Development Team and ensures the matrix team remains aligned and engaged toward that vision + Oversees relevant sub-teams and ensures clear goals are aligned with development team short- and long-term and performance standards are in place. Provides feedback and coaching and holds sub-team leaders accountable for key deliverables + Manages performance across the matrix team, in collaboration with the functional leaders. + Demonstrates peer-to-peer influence across R&D functional leadership + Establishes trusting relationships locally and globally across the enterprise to advocate for the asset **Stakeholder Engagement & Communication** + Manages integration points and communications with key stakeholders across all Otsuka functions and market areas to ensure alignment and minimize risk + Monitor and manage contractual obligations, performance metrics, and governance structures. + Ensures appropriate decisions are made in a timely manner and effectively navigates relevant governance to keep stakeholders informed and aligned while driving outcomes + Builds and manages relationships with external stakeholders (Opinion Leaders, Patient advocacy leaders, health authorities) + Support interpretation of key clinical trial results, regulatory feedback and other relevant information and lead the integration of these new findings into the cross-functional asset strategy **Qualifications** Required + A minimum of 10 years of experience in the pharmaceutical industry, extensive working knowledge in the drug development process with proven progression in relevant R&D roles and significant experience in related therapeutic areas as well as pediatric drug development. + Experience in managing/leading high performance, cross-functional teams (Matrix) or complex organizations successfully + Understanding of regulatory policies and impact of public relations (US and Global preferred) + Demonstrated ability to successfully and effectively collaborate, cooperate and work across boundaries (e.g. R&D, disease mgt., marketing, external development) and building strong external relationships + Abreast of scientific issues as they impact business development and strategic planning + Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets + Understanding of regulatory policies and impact of public relations + Demonstrated use of communication and change management strategies/tactics to influence new ways of thinking and working + Success in effectively communicating and influencing decisions with senior management + Ability to navigate through ambiguous and changing healthcare landscape + An ability to communicate effectively in meetings and via written and oral presentations is essential. This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing. + Understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings + Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies. + Willingness to travel 35% of time, over weekends and ability to travel internationally.. Preferred + MD / PhD / PharmD / secondary scientific degree preferred or commensurate experience + Medical, clinical and/or public health experience within the therapeutic area of psychiatry or neurology **Disclaimer** This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $249,973.00 - Maximum $388,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The PCP/Endo Business Specialist is responsible for developing and implementing a plan for maximizing net sales of BIPI and co-promoted diabetes products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The PCP/Endo Business Specialist will conduct their business with key targeted healthcare providers and community hospitals, and may have additional responsibilities in teaching hospitals, federal and military hospitals, managed health care facilities, group purchasing organizations, integrated delivery networks, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Compensation Data This position offers a base salary typically between ($95K) and ($153,100k). The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. Duties & Responsibilities Utilizes product knowledge and demonstrated selling skills in order to influence targeted health care professionals to support the use of BIPI promoted diabetes products. Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. Completes pre-call plans to meet key stakeholder needs. Builds discussion around customer needs and opportunities. Fosters customer network development and communication. Has accurate and timely follow-up discussions with customers. Fosters ongoing trust with customer as relationship develops. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. Identifies top plans for customers. Engages customers in comprehensive discussions on the payer environment, co-pays, and formulary access. Works with Managed Care Area Managers to generate and sustain support for products on MCO formularies. Develops and influences an extended team to pull-through MCO decisions. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. Analyzes qualitative and quantitative territory information to optimize territory business plan and customer calls. Monitors local market conditions for changes that impact business. Develops plans to optimize allocation of key resources, including samples, co-pay cards, funds for speaker programs, and funds for in-office meals. Adjusts implementation plans on a regular basis (speaker mgmt., advocate development, etc.). Leverages opportunities that meet both territory and brand tactics. Utilizes supporting analysis tools to plan activity, report and monitor resource utilization, and maintain account and customer records. Completes all administrative responsibilities as directed by management. Successfully completes all Sales Training requirements. Identifies thought leaders, innovators and advocates to support BIPI products. Works with trained speakers for diabetes topics and products. Provides feedback and follow-up to speakers and attendees. Initiates contacts and network-building among advocates and customer groups. Develops plans to develop speakers and thought leaders. Manages programs and budgets to stay within standards. Works effectively with all customer-facing roles (i.e. Account teams, Medical teams, etc.) in a given geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community. PCP/Endo Business Specialist Requirements Bachelor's degree from an accredited institution is preferred. A minimum of two (2) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred. History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. “Export Laws” means the Export Administration Regulations (“EAR”) of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time. Executive PCP/Endo Business Specialist Experience in diabetes therapeutic area preferred History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. “Export Laws” means the Export Administration Regulations (“EAR”) of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a Quality Systems Engineer- Self Inspection & Audit/Inspection Readiness opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The Quality System Engineer, Self-Inspection & Audit/Inspection Readiness, is responsible for managing and maintaining the site's internal audit (self-inspection) program to ensure continuous compliance with current Good Manufacturing Practices (cGMP), company policies, and global regulatory standards. This role plays a vital part in proactively identifying site compliance risks, supporting quality system improvements, and maintaining a constant state of inspection readiness for external health authority audits. The successful candidate will promote data integrity, quality, and compliance across a broad range of Quality Assurance (QA) activities and collaborate closely with cross-functional teams at Astellas Regenerative Institute of Medicine (AIRM) to ensure consistent delivery of high-quality products to patients. Essential Job Responsibilities: * Audit program administration: Develop, implement, and maintain the annual self-inspection master schedule/matrix to plan, conduct, and track audits or inspections across departments, processes, and quality systems. * Audit Execution: Lead/co-lead, participate and support internal audits across all GMP-regulated areas, including manufacturing processes/cleanrooms, quality control, materials management, facilities, engineering, etc. * Documentation & Reporting: Prepare and maintain inspection checklists and questionnaires. Accurately document audit observations and findings using a risk-based classification system (e.g., critical, major, minor). Draft and issue formal audit reports summarizing results and recommendations. * Communication and Follow-up: Communicate audit results to stakeholders, identify trends, and support follow-up activities to ensure timely completion of action items. * Corrective & Preventative Action (CAPA): Collaborate with auditees and department representatives to develop effective CAPA plans for addressing identified deficiencies. Track progress, ensure timely completion, and assist with effectiveness verification activities. * Metrics & Reporting: Prepare and maintain monthly audit-related metrics and dashboards for review by Quality Assurance and site management during Quality Council or Management Review meetings. * Inspection Readiness: Support the development and maintain the site's inspection readiness plan, including managing checklists, tracking action items, and supporting readiness training. Act as audit host (inspection administrator) or support representative during corporate, regulatory, or third-party audits. * Continuous Improvement: Participate in continuous improvement initiatives to identify efficiencies and enhance compliance and operational excellence across QA and related departments. * Additional Duties: Perform other quality-related duties and participate in ad hoc projects as assigned.

_At Otsuka our mission is to create new products for better health worldwide. Our purpose is to defy limitation so that others can too._ In this exciting role, as a Sr. Analyst within OAPI supply chain team, you will work cross-functionally across various departments to support implementation of the S&OP (Sales & Operations Planning) process. You will assist in managing a complex portfolio of products with competing priorities that include balancing inventory, managing vendor / supplier relationships, optimizing total delivered cost to meet finished goods demand with focus on delivering value to our patients, our suppliers, and to Otsuka. You will create an environment for proactive communications with cross functional collaborators that will help ensure both internal and external customer demands are consistently met with no laps in supply and availability of products to our patients. Additional facets of the role include coordinating purchase requisitions in the ERP system, monitoring supplier performance KPIs and reporting, leading escalation process in collaboration with cross-functional partners to mitigate service impacts, support inventory management for new product launches, develop and drive continuous improvement initiatives across the Supply Chain that create capacity and/or improve service. Given more independence and autonomy over the tasks, activities, and projects **** **Job Duties could include** : Planning + Leads demand planning meetings with internal business partners (Marketing, Finance, Channel Strategy, etc.) gathering total demand for new and existing finished good SKUs. + Develop and manage product manufacturing and distribution plans for new and existing products that provides continuous supply to customers, including international product. + Create and maintain replenishment plans for finished products of responsible territories and create replenishment orders to sites at the planning time fence. + Develop and implement safety stock with sufficient shelf-life in alignment with desired customer service levels to meet inventory objectives and targets. + Less supervision required by management and/or team leadership on necessary targets + Communicate the manufacturing plan with all internal and external parties + Issue and manage purchase orders and work with drug product plants and packaging CMO's to ensure product plan is executed on time + Manage communications with interdisciplinary teams (Vendors, Channel Strategy, Global Product Quality, Quality Control, Finance, Legal, Packaging, etc.) to monitor process and provide feedback + Identify exceptions raised against existing replenishment plans and work with third party suppliers or site production planners to negotiate resolution and adjust plans to reflect changes in demand and supply to ensure that adequate production takes place to meet market demands. + Lead regular Sales and Operations Planning (S&OP) meetings with all internal key functional areas to share performance and gain alignment on future actions. + Communicate results to all levels of the organization. + Monthly reporting of supply chain metrics and partner with finance on month end close activities and J-SOX controls + Monitor inventory levels and tracking of stock movements, including completing inventory reconciliation + Leads with transportation and logistics, prepare/review release documentation in conjunction with GPQ, manage invoice discrepancies, maintain relevant master data, and other activities as needed Distribution and Logistics + Support transaction management and postings in ERP system. + May lead interfaces, transactions, and postings in ERP system. + Transact and document inventory movements and reconciliations, return and claim approvals, and product destructions. + Manage inventory reporting and communicate to appropriate parties. + Support transaction management and postings in ERP system. + Coordinate pick/pack/ship activities with 3PL ensuring full and on-time delivery to meet targeted customer service level. + Coordinate packing instructions for new routes, shipping configurations and/or transportation methods together with packaging and quality teams. + Coordinate international and intercompany shipment orders with customers and 3PL, including shipping forecast, communications, documentation, and issue resolution. + Maintain order transactions and postings in ERP system. + Assist in serialization process setup and data transaction event resolution to comply with DSCSA requirements. + Assist with demand forecast and calculate budget for distribution expenses, generate POs for distribution services, manage invoice allocation and payment approvals. + Collaborate with Finance team on expense allocations, budget forecast, accruals, and related activities. Vendor Management + Support Vendor/Supplier relationships for Contract Manufacturing, Supply Chain, Packaging, Distribution & Logistics vendors within the defined Tiers. + Proactively monitor supply chain and packaging risks, capture and report supplier performance data to Manager, Supply Chain **Qualifications** Required + Education: Bachelor's degree in: Business, Engineering, Supply Chain, or related field + Years' Experience: 2-5 + Technical Skills: Business Analytical skills, Project Mgt., ERP, MS 365 Suite + Power, Management, and Leadership Skills: Negotiation, Team Leadership, Networking + Communication Skills: Well Organized (thought, communication, work) + Cultural Experience: Dealing with ambiguity, curious mindset, adaptative, be a part of a multi-team approach. + Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals Preferred + Certifications: APICS + Technical Skills: GMP, SAP S4 HANA + Industry Experience: Pharma, Med. Device, Food **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $86,661.00 - Maximum $124,545.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in the development of protocols and statistical designs in different phases of the clinical trials leading to approval of drug products in different phases of the clinical trials. This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. You will report to the Senior Director, Biostatistics. **** + Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development + As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, annual reports and PSUR + Develops Statistical Analysis Plan (SAP) and mock TFLs for interim or final analyses + Participate strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and publications. + Core team of developing final study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other scientific meetings. + Serves as the Biometrics Trial Lead (BTL) in the project team and provides expertise and input regarding the statistical analysis, TFLs format and data collection and quality, and overall timeline. + Provides technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks. + Takes full responsibility in managing biostatistical tasks (as listed above) for one therapeutic area and provides strategic technical support to other clinical projects. + Provides technical direction to supporting statisticians working on projects on a day-to-day basis. **Qualifications/ Required** **Knowledge/ Experience and Skills:** + Understands the company's products, the competition, and the pharmaceutical industry in general. + Demonstrates a competent knowledge of the company's work tools, processes, and policies. + Maintains a current awareness of new drug developments and statistical methodologies in the business. + Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions. + Effective communications within biostatistics function and with study team and key stakeholders across different functional areas such as clinical, regulatory affairs, asset management, safety and clinical operation. + Familiar with regulatory submission process in US and EU. **Skills** + In-depth knowledge of statistical principles, applications, and SAS/R programming software. + Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Knows how/when to apply organizational policy or procedures to a variety of situations. **Educational Qualifications** + PhD or Master's degree in Statistics or Biostatistics. + Minimum 7 years (PhD) or 9 years (master degree) of experience in the pharmaceutical industry Experience in CNS area is a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Astellas Institute for Regenerative Medicine (AIRM)** is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a **QC Scientist I Raw Materials** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. **Essential Job Responsibilities:** + Develop/author/revise technical reports and laboratory procedures (SOPs, methods) + Execute and troubleshoot raw material testing in support of production activities + Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures + Design and perform testing in support of method transfer/validation/qualification/verification + Review/authorize data and perform analysis and interpretation of test results and trends + Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations + Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration + Support and mentor junior team members + Collaborate with other network sites to share best practices + Other duties as required **Quantitative Dimensions:** The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. **Organizational Context:** The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization **Qualifications** **Required:** + B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role + Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays + Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing + Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements) + Ensures inspection, testing and release timelines are met. + Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data + Experience using LIMS as an end user; Excellent technical writing and verbal communication skills + Must be capable of observing and adhering to lab safety standards and procedures + Successfully performs work independently with minimal instructions + Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements + Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion + Highly self-motivated and goal oriented + Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Astellas Operations team to execute work and will be expected to perform other duties and/or special projects as assigned **Preferred:** + Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment + Experience in qualification of analytical equipment, including those with computerized systems + Experience in method validation/qualification/verification/transfer **Working Conditions:** + This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. + This is an on-site role working in a cGMP regulated manufacturing facility. **Salary Range** : $91,000-$143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program _All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._ \#LI-TR1 Category Massachusetts TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

**Senior Manager, Digital Content and Social Strategy** The Senior Manager, Digital Content & Social Strategy is responsible for shaping and amplifying Otsuka's external digital presence across our corporate website, social platforms, and emerging digital touchpoints. This role drives integrated content strategies that elevate our corporate voice, strengthen reputation, and build advocacy for our science, our leadership, and our commitment to redefining what's possible for the people we serve. Reporting to the Director of Corporate Brand and Reputation, the Senior Manager leads corporate website governance, social media strategy, analytics, digital storytelling, and executive social programs. This professional excels at cross-functional collaboration, "story mining," and translating complex concepts into compelling, audience-centric narratives. **Key Responsibilities** **Corporate Website Content & Governance** + Own content strategy, editorial planning, and day-to-day governance for the corporate website. + Ensure accuracy, clarity, UX alignment, and brand consistency across all digital content. + Collaborate with IT, legal, and cross functional teams to manage updates, optimizations, and new feature implementations. + Maintain governance frameworks, content workflows, and quality standards. **Social Media Strategy & Channel Management** + Develop and execute a modern, insights-driven social media strategy aligned to enterprise and TA priorities. + Manage corporate social channels, including content planning, publishing, community monitoring, and escalation protocols. + Partner closely across Corporate Affairs, R&D, Commercial, and enabling functions to ensure messaging accuracy and compliance. + Identify emerging platforms, formats, and opportunities to increase visibility and engagement. **Executive Social Media Strategy & Execution** + Build and manage executive social presence strategies for senior leadership. + In conjunction with External Communications colleagues, support thought-leadership perspectives, and platform-fit messaging that amplify leadership voice and strengthen reputation. + Provide performance monitoring, and continuous optimization. **Analytics, SEO & Performance Optimization** + Lead analytics and reporting across web and social channels to measure impact and inform strategic decisions. + Oversee SEO strategy and implement optimizations to increase discoverability of corporate content. + Translate data into actionable insights, trends, and recommendations for stakeholders. **Digital Storytelling & Cross-Functional "Story Mining"** + Proactively uncover compelling stories across R&D, commercial, corporate affairs, social impact, culture, and innovation. + Translate complex scientific and organizational topics into accessible, narrative-driven content. + Drive editorial planning and cross-channel storytelling that differentiates Otsuka in the industry. + Partner across the Communications team to ensure digital storytelling reinforces broader communications strategies and integrates across enterprise-TA-brand goals. **Qualifications** + 7-10+ years of experience in corporate communications, digital content strategy, social media, or related fields. + Proven success managing corporate digital channels, preferably in highly regulated or science-driven industries (biotech, pharma, healthcare, technology, etc.). + Strong writing, editing, and storytelling capabilities with sharp editorial judgment. + Expertise in analytics tools (e.g., Google Analytics, Statusbrew, platform-native insights, etc.), SEO best practices, and performance optimization. + Ability to translate complex subjects into clear, engaging content for diverse audiences. + Experience partnering with executive leaders on digital presence and thought leadership. + Strong project management, cross-functional collaboration, and stakeholder-alignment skills. + Ability to thrive in a fast-paced environment and manage multiple projects simultaneously. Educational Qualifications + Bachelor's degree in communications, marketing, brand strategy or related field **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. **Position Overview:** The Director of Field Strategy and Operations serves as the orchestrator of field strategy, ensuring that prioritization, stakeholder engagement, and execution are effectively aligned with brand strategy and enterprise objectives. This role provides leadership across multiple regions, enabling a holistic, enterprise-wide approach to field strategy and operational excellence. This role also partners closely with the Business Analysis team to ensure field teams have access to standardized dashboards and data-driven insights, supporting execution excellence and performance tracking. The Director will be the point of contacts for ad hoc analytics requests, ensuring field teams have the right data to make informed decisions, but will not be creating these reports themselves or with their team and will work with Business Analysis to ensure accurate measurement and proper data is used. **Key Responsibilities:** + **Strategic Prioritization & Field Execution:** Align field activities with marketing strategy, launch planning, and market access pull-through, ensuring execution efficiency. + **Execution Excellence & Field Performance Tracking:** Oversee Omnichannel efforts, account planning, and KPI tracking, ensuring insights from Field Analytics support execution. + **Strategic prioritization & orchestrating field execution: Analyzes current and future state of the business based on insights and trends, and** leads efforts to align field activities with high-priority initiatives such as marketing strategy, launch planning, and market access pull-through. + **Field Communication & Data-Driven Decision Support:** Act as the primary field communicator, ensuring clarity on CRM tools, performance insights, and operational priorities. + **Resource Allocation & Budget Optimization:** Optimize the distribution of budgets, speaker programs, and promotional resources, leveraging data-driven insights to maximize ROI. + **Team Development & Analytics Training:** Mentor team members on business reviews, reporting systems, and analytics interpretation, working with Business Analysis to enhance field intelligence capabilities. + **Compliance Management:** Must comply with all state and federal laws, regulations and guidelines including PhRMA Code on Interactions with Healthcare Professionals as well as complying with all OAPI standards and policies relating to all job activities. **Qualifications:** + Bachelor's degree required; MBA or advanced degree preferred. + Minimum of 10 years of pharmaceutical experience, with a strong understanding of sales force operations and execution. + Prior experience in field leadership roles such as first- or second-line leadership, regional operational and customer strategy roles or other field-based support roles required. + Established expertise in business analytics, business operations, sales support, and resource management within a commercial pharmaceutical organization. + Ability to focus on priorities and resolve operational issues effectively. + Excellent communication and collaboration skills, with the ability to work cross-functionally and drive execution efficiency. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $194,247.00 - Maximum $290,375.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas is announcing a Computational Chemist Lead opportunity at their Astellas Innovation Management (AIM) site in Cambridge, MA. Purpose: This role supports drug discovery efforts by applying advanced computational chemistry techniques to design and optimize small-molecule therapeutics. The position requires close collaboration with internal teams and external CROs to accelerate candidate selection and improve research productivity. The successful candidate will lead strategy across multiple programs and shapes the computational chemistry platform/standards in Innovation Lab, working closely with global teams. As Computational Chemist, you will be expected to contribute across multiple therapeutic areas and drug discovery efforts across various modalities including small molecules, proteins, bifunctional degraders, and biologics. Essential Job Responsibilities: Computational Drug Design: Apply molecular modeling, docking, molecular dynamics, homology modeling, and structure-based design to guide compound optimization Use cheminformatics and machine learning tools to analyze SAR, ADME/Tox profiles, and predict compound behavior. Develop generative models, reinforcement learning pipelines, and predictive analytics for compound design and optimization Curate chemical libraries, manage data pipelines, and support SAR/ADME analysis Can make recommendations on compound progression, integrate new platforms and tools and can make Go/No-Go decisions on compound progression, setting project goals and defining plans Drug Design & Synthesis: Design novel compounds based on ADME and SAR principles; optimize lead molecules for potency, selectivity, and pharmacokinetics. Data Analysis & Reporting: Analyze large datasets from simulations and experimental data with scientific rigor; interpret computational results and prepare detailed research reports and present findings internally and externally to technical and non-technical audiences. Cross-functional Collaboration: Work closely with medicinal chemistry, biology, pharmacology, protein science, and preclinical teams to ensure drug candidates meet efficacy and safety standards. Participate in program-related meetings and contribute strategic insight Intellectual Property: Identify and protect IP through patent filings and strategic documentation. Ensure accurate documentation of compound synthesis and project data Foster a collaborative, transparent, and creative team environment that drives innovation and invention. Close partnership with colleagues in Japan is expected. Technology Integration: Explore and apply cutting-edge technologies and global scientific trends to enhance research capabilities Stay current with scientific literature and emerging technologies Manage team priorities and resources in alignment with the company's overall I-Lab strategy and objectives CRO Management Oversee computational chemistry execution at CROs, including troubleshooting and performance enhancement Evaluate and onboard new CROs to improve cost-efficiency and research quality Maintain weekly communication and productivity tracking with CRO teams

The Director, Nephrology & Immunology Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the Nephrology and Immunology therapeutic area. This role ensures the timely, accurate, and compliant communication of scientific and clinical data through congress abstracts, posters, manuscripts, and other peer-reviewed outputs. Serving as the functional lead for publication operations within the Nephrology & Immunology Medical Communications team, the Director partners closely with cross-functional stakeholders, including Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Medical Strategy, Core Content, and external vendors, ensuring excellence and consistency in scientific communication across the portfolio. The position reports to the Senior Director, Nephrology & Immunology Medical Communications Lead and plays a key leadership role in advancing Otsuka's mission to deliver impactful, evidence-based science that improves patient outcomes. **** **Key Responsibilities Include:** **Publications Strategy and Execution** + Lead execution of the publication plans for Nephrology and Immunology assets, ensuring strategic alignment with global medical objectives, data dissemination priorities, and the product lifecycle + Partner with Medical Communications and cross-functional teams to define publication timelines, data priorities, and congress/journal strategies in collaboration with study teams and medical leaders + Oversee the end-to-end development of publication deliverables, including abstracts, posters, and manuscripts to ensure scientific accuracy, quality, and adherence to Good Publication Practices (GPP), ICMJE, and company SOPs + Support the integration of publication insights into broader scientific communication platforms (SCPs), ensuring consistency across core content, field materials, and other medical channels **Vendor & Budget Management** + Manage publication vendors and medical writing partners to ensure timely delivery, cost-effectiveness + Oversee operational management of external publication agencies, providing clear direction, review, and feedback to ensure alignment with scientific and compliance standards + Manage assigned publication budgets, including forecasting, tracking, and reconciliation + Ensure efficient resource utilization and drive continuous process improvement across publication workflows **Cross-functional Leadership** + Collaborate closely with Clinical Development, Global Integrated Evidence & Innovation, Medical Strategy, and Core Content teams to ensure data readiness, accurate interpretation, and timely publication of key clinical results + Serve as a publications subject matter expert within the Nephrology & Immunology Medical Communications function, providing strategic and operational guidance to internal stakeholders and vendors + Partner with Field Medical and Medical Information to ensure consistency of published data messaging across medical channels and external communications + Contribute to integrated medical communication planning, ensuring that publications effectively support data dissemination goals and launch readiness activities + Consider technology and AI to support workflow improvement **Compliance & Quality Oversight** + Ensure all publication activities are conducted in accordance with internal SOPs, GPP, ICMJE, and regional/global regulatory requirements + Partner with Legal, Regulatory, and Compliance teams to uphold publication governance, authorship transparency, and ethical data sharing standards + Contribute to audit readiness and documentation best practices for publication records and approvals **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) required + 10+ years of experience in Medical Affairs, Medical Communications, or Publications within the pharmaceutical or biotechnology industry + Minimum 3-5 years of experience leading publication planning and execution for global or regional programs, preferably in Nephrology, Immunology, or related therapeutic areas + Proven experience managing vendors and external medical writers, including budget oversight and performance evaluation + Strong understanding of Good Publication Practices (GPP), ICMJE guidelines, and industry standards for scientific and medical communication **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Demonstrated ability to lead publication strategy execution across global and regional teams + Exceptional project management and organizational skills, with the ability to manage multiple concurrent publication deliverables + Excellent written and verbal communication skills, with meticulous attention to scientific accuracy and compliance + Strong cross-functional collaboration skills, with the ability to influence and align internal and external partners + Proven leadership in vendor management, process optimization, and publication operations + Financial acumen and experience managing publication budgets + Strategic thinker with operational excellence mindset and the ability to translate complex data into clear, evidence-based scientific narratives **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The Discovery Targeted Therapy Research team at Astellas is seeking a highly accomplished and visionary scientist to drive innovative research initiatives in oncology drug discovery. This role is ideal for a candidate who has a proven track record of successfully designing, executing, and leading discovery-phase research programs targeting cancer biology. The candidate will be responsible for being a member of a research program team to generate new ideas, develop study plans, conduct pharmacology studies, meet timelines, actively engage with global R&D stakeholders, and deliver high-value products. Essential Job Responsibilities: This position directly impacts our ability to prosecute our company goals of maintaining an early-stage pipeline of potential drug candidates. The measures of success are the advancement of new targets through the successive stages of the drug discovery pipeline. Their components are: Pipeline Advancement: Contribute to the strategic expansion of Astellas' oncology pipeline by identifying promising drug targets and ensuring robust preclinical validation aligned with clinical development strategies. Strategic Program Leadership: Conceive and manage oncology-focused drug discovery programs from early concept through preclinical development. Collaborate across multi-disciplinary teams including biology, chemistry, translational science, and clinical development to align scientific goals with strategic business objectives. Scientific Innovation & Execution: Design and execute research studies that identify and validate therapeutic targets across a range of cancer indications focusing on GI & GU. Apply cutting-edge techniques in molecular biology, cellular assays, and in vivo models to support candidate selection. Data Analysis & Communication: Utilize advanced analytical tools to interpret complex biological datasets, derive actionable insights, and present findings to cross-functional stakeholders and leadership. Cancer Biology Expertise: Develop deep understanding of tumor biology, resistance mechanisms, and biomarker development. Focus on emerging areas such as targeted protein degradation, synthetic lethality, or immune-oncology strategies to enhance therapeutic efficacy. Collaboration: Proactively foster strategic partnerships with leading academic institutions, clinical research centers, and biotech companies to accelerate the discovery of transformative cancer therapies.

The Executive Director, Field Enablement leads the strategy, execution, and continuous optimization of field systems, training and development, logistics, and HCP engagement operations that support sales force effectiveness. This leader oversees four core functional areas: 1) Field Technology - CRM, field reporting, and mobile tools, 2) Field Enablement - Fleet, sample operations, and territory alignment, 3) HCP Program Operations - Speaker Bureau, advisory boards, and congress support, and 4) Field Training and Development - Field Sales and Market Access Training, Field Leadership Capabilities, and Instructional Design & Learning Technology. The Executive Director partners closely with Field Strategy & Operations, Sales and Market Access Leadership, Medical Affairs, Brand Teams, and People and Business Services to ensure all tools, processes, program offerings, and infrastructure are aligned with business priorities and compliance expectations. This role leads a high-performing team to drive scalable, field-focused solutions across the commercial organization Key Responsibilities **Strategic Field Enablement Leadership** · Translate commercial strategy into practical, scalable systems, training and development programs, and services that support field execution. · Partner with Field Strategy & Operations on CRM enhancements, territory planning, and field optimization efforts. · Drive alignment and integration across field enablement, brand teams, s, Sales, Market Access, and other key enabling functions and cross-functional partners · Developing and leading effective training and development solutions and programs for commercial field employees, including sales leadership capabilities in partnership with People and Business Services **Functional Oversight** · Field Technology: Lead vision and enhancements for Veeva CRM, field dashboards and reporting, and mobile platforms. · Field Enablement: Ensure efficient, compliant execution of fleet operations, sampling processes, and territory alignments. · HCP Program Operations: Oversee strategy and execution of Speaker Bureau, advisory boards, and congress logistics, through direct leadership of the Associate Director, HCP Program Operations. · Field Training and development: Overseeing strategy and execution of Field Sales and Market Access Training, Field Leadership Capabilities, and Instructional Design & Learning Technology **Cross-Functional Collaboration & Compliance** · Collaborate with Sales, IT, Medical, Compliance, Legal, and Marketing to align on systems, engagement standards, and risk mitigation · Maintain audit-ready documentation, SOPs, and metrics for all field and HCP-facing operations. · Serve as a key stakeholder in governance efforts related to HCP interactions and field infrastructure. **Team Leadership & Development** · Lead a team of senior professionals across each functional area, fostering collaboration and accountability. · Build capabilities and talent pipelines to support current needs and future growth. · Promote a culture of operational excellence, innovation, and service to the field. **Change Management & Adoption** · Drive planning and rollout of new systems, processes, and operational models. · Deploy Training to ensure field teams are prepared and supported through change. · Leverage feedback and data to inform improvements and ensure adoption across teams. **Qualifications & Experience** **Required** : · Bachelor's degree in Business, Operations, or related field · 12+ years of experience in field operations, commercial systems, or HCP program management · Proven track record leading field-facing functions across large, matrixed organizations · Expertise in Veeva CRM, sample management, and speaker program governance · Strong cross-functional collaboration and team leadership skills **Preferred** : · Experience in pharmaceuticals, biotech, or healthcare · Experience leading design and deployment of Field and Leadership Capabilities training and development programs/services · Familiarity with compliance regulations such as the PhRMA Code and Sunshine Act · Background managing large-scale system rollouts and cross-functional field initiatives **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a Quality Systems Engineer- Self Inspection & Audit/Inspection Readiness opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The Quality System Engineer, Self-Inspection & Audit/Inspection Readiness, is responsible for managing and maintaining the site's internal audit (self-inspection) program to ensure continuous compliance with current Good Manufacturing Practices (cGMP), company policies, and global regulatory standards. This role plays a vital part in proactively identifying site compliance risks, supporting quality system improvements, and maintaining a constant state of inspection readiness for external health authority audits. The successful candidate will promote data integrity, quality, and compliance across a broad range of Quality Assurance (QA) activities and collaborate closely with cross-functional teams at Astellas Regenerative Institute of Medicine (AIRM) to ensure consistent delivery of high-quality products to patients. Essential Job Responsibilities: Audit program administration: Develop, implement, and maintain the annual self-inspection master schedule/matrix to plan, conduct, and track audits or inspections across departments, processes, and quality systems. Audit Execution: Lead/co-lead, participate and support internal audits across all GMP-regulated areas, including manufacturing processes/cleanrooms, quality control, materials management, facilities, engineering, etc. Documentation & Reporting: Prepare and maintain inspection checklists and questionnaires. Accurately document audit observations and findings using a risk-based classification system (e.g., critical, major, minor). Draft and issue formal audit reports summarizing results and recommendations. Communication and Follow-up: Communicate audit results to stakeholders, identify trends, and support follow-up activities to ensure timely completion of action items. Corrective & Preventative Action (CAPA): Collaborate with auditees and department representatives to develop effective CAPA plans for addressing identified deficiencies. Track progress, ensure timely completion, and assist with effectiveness verification activities. Metrics & Reporting: Prepare and maintain monthly audit-related metrics and dashboards for review by Quality Assurance and site management during Quality Council or Management Review meetings. Inspection Readiness: Support the development and maintain the site's inspection readiness plan, including managing checklists, tracking action items, and supporting readiness training. Act as audit host (inspection administrator) or support representative during corporate, regulatory, or third-party audits. Continuous Improvement: Participate in continuous improvement initiatives to identify efficiencies and enhance compliance and operational excellence across QA and related departments. Additional Duties: Perform other quality-related duties and participate in ad hoc projects as assigned.

The Field Force Effectiveness team at Otsuka America Pharmaceutical, Inc. plays a highly visible role in optimizing the performance of the sales and marketing efforts, for the field sales teams. As a result, Systems Training plays a key role in ensuring that the sales force understands how to effectively utilize our technology to enhance customer interactions, optimize selling opportunities and provide insight on our business processes that support our business. The Senior Manager of National Systems Training work with the field sales teams to design, develop and deliver new hire systems tech training on our InGenius (CRM System), ORION (Field Reporting) and Business Planning system across all brands. The role is also responsible or continual training on system enhancements and capabilities for the organization. In addition, the role will require system training content updates and cross collaboration between systems owners and multiple departments such as compliance, operations, IT, sales leadership, and marketing partners. The Senior Manager of National Systems Training will report to the Director, of Marketing and Sales Technologies and partner closely Training & Development & Home Office functions. In addition, the role will work with our internal Field Force Effectiveness points to identify user experience improvements and capabilities that better support a seamless customer interaction in the field. **Core Responsibilities:** + New Hire system training CRM, Field Reporting and Business Planning across all commercial sales teams + Responsible for developing and updating training materials and curriculum to reflect system enhancements + Provide ongoing training on system enhancements to support the field sales teams + Coordinate with Field Training and Development teams on New Hire Training content and agenda + Identify key user experience insights and ongoing system training opportunities collected from field ride observations + Incorporate business processes education in training sessions to support Otsuka's ways of working + Work closely with the Field Force Effectiveness team to identify user experience improvements + Partner with system owners to design training content to support enhancements and new capabilities + Develop pull through strategies to support ongoing system and business process learnings for the field. Such as Specialty Attestation, Customer Affiliations, Precall and Post Call Planning, Field Reporting Insights etc. + Work closely with cross-functional teams and stakeholders to define training needs and requirements **Qualifications:** Required + Bachelor's degree: MBA or other related graduate degree preferred + Ability to communicate technical information in a way that is easy to understand for the field and effectively identify key selling opportunities + Strong command of CRM, Field Reporting and Business Planning systems and the ability to train on them + Previous experience in a Region or Ecosystem point role that supports training and coaching field team members + Ability to work in an ambiguous environment undergoing transformation + Excellent communication, collaboration, facilitation, and presentation skills + Possess a growth mindset that is open to development & coaching and willing to challenge the statue quo + Proven track record for consistently meeting or exceeding performance goals + Understands and articulates healthcare compliance, legal and regulatory landscape + Technical acumen and understanding the backend systems + Experience selecting and managing training vendors + Abilify to create content in PowerPoint or other tools Preferred + Previous experience in a field leadership or coaching role that supports business acumen development of the sales team members + Experience as a training in the pharmaceutical industry + Understanding of principles of instructional design and adult learning theory + Experience with putting material through the Promotional, Regulatory and Compliance Review Process **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: * Develop/author/revise technical reports and laboratory procedures (SOPs, methods) * Execute and troubleshoot raw material testing in support of production activities * Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures * Design and perform testing in support of method transfer/validation/qualification/verification * Review/authorize data and perform analysis and interpretation of test results and trends * Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations * Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration * Support and mentor junior team members * Collaborate with other network sites to share best practices * Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization