Associate Director jobs at CymaBay Therapeutics

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 ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: Member of cross-functional teams, the primary purpose of the Associate Director is to act independently as Lead Safety Statistician (LSS) / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for complex/novel work in an established area (safety/clinical/ observational studies, MA tactic, Biomarker & PK/PD Analyses or local project), This position may also act as Global Statistical Lead (GSTATL) for an early or back up asset or as a Methodology expert validating the execution of complex techniques. The position is expected to complete these tasks with minimal supervision from the GSTATL, LPS or the Primary Focus Statistics Lead (PFSL). Under the supervision of an experienced statistician, the position can act as global safety statistical lead for a late phase or novel asset or represent Astellas on statistical matters related to safety data, clinical data, Biomarkers, PK/PD, PROs, or methodology at meetings with regulatory authorities, key opinion leaders and HTAs. The position may also research innovative solutions and train other statisticians. Essential Job Responsibilities: Provides best in class safety data science and statistical support to the asset level for Astellas drug development programs. For assigned projects, provides all required safety statistical support and deliverables by supervising another statistician, or as a member of study team. * Ensures quality and consistency of key safety data science deliverables. * Accountable for the Asset Level Safety Assessment Plan (ALSAP). * For early or non complex asset, independently provides strategic safety statistical input to the asset teams (for example, CDP, CMP, go/no go approach, OCs ) including design of studies and analyses requiring advanced statistical methodologies. * Executes biomarker and PK/PD strategies, leads large/complex studies or supports marketed products for a safety purpose. * Contributes to regulatory and payer dossiers and publications - provides statistical interpretation of the results. * Presents summary data and analyses to key stakeholders in a compelling and clear manner * Ensures availability of safety-related data, biomarker, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs. * May participate in due diligence activities, reviews safety data and advises company * Is responsible to implement, explain and validate complex safety statistical methodology Personal Development / Collaboration * Recognizes and addresses issues which may impact the statistical integrity of the development program or for which novel statistical methodology may add value * Contributes to cross-functional or indication level improvement initiatives (i.e write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards - selection and qualification/audits of vendors) * Contributes to the recruitment, training, professional development and retention of statistical personnel. * is a member of external industry or professional organizations, developing relations with leading academic institutions, advising internally on innovative Statistical methods or checking their correct implementation.

Responsible for working with cross-functional teams across the organization to drive and align the development and maintenance of global labeling (e.g. CCDS, regional product labels, and patient labeling) for assigned compounds. Makes recommendations and provides labeling advice and feedback for labeling content, processes, and timelines to ensure compliance with labeling regulations and guidance. Delivers high-quality submission labeling and artwork for complex drug products, specific therapeutic/disease areas, and cross functional teams. Actively contributes to continuous improvement of end-to-end labeling processes and systems. **** + Act as Global Labeling Strategy Lead, supporting preparation, review, and update of content for the development and maintenance of Company Core Data Sheet (CCDS), local labeling and labeling components. + Lead the cross-functional labeling team for assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key messaging. + Evaluate and communicate risks associated with CCDS content updates and implementation strategies. + Drive labeling for package labeling (artwork) development, update, and maintenance through collaboration with a cross-functional team. + Support global HA interaction strategy regarding all aspects of labeling, including submissions, responses to questions, and negotiations. + Demonstrate understanding of current labeling content requirements, regulations, and guidance to ensure all assigned compound labeling documents are accurate, consistent, and compliant. + Assess competitor labeling in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling + Support creation, compliance, update, and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings are current and accurate (DailyMed, NDC Directory, Establishment Directory, etc). + Manage and maintain labeling documents in document management systems; Manage label review and approval. + Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.). + Support inspection readiness activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global Otsuka colleagues, Otsuka affiliates and Alliance partners, as needed. + Develop clear communications for senior management and labeling stakeholders, to streamline and facilitate label development, negotiations, and approval. + Review and propose continuous improvements to Global Labeling policies, end-to-end processes, quality, and system tools. + May be assigned additional responsibilities, as deemed necessary. **Qualifications** Required + MS/BS in life sciences or other scientific field. + 6-8 years of relevant experience in pharmaceutical regulatory/labeling environment and/or drug development + Knowledge of scientific principals and regulatory systems, relevant to drug development + Experience writing CCDS and local labeling documents for new products. Preferred **Knowledge and skills** + Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required + Solid understanding of implications of global labeling across the organization and globally + Solid understanding of the structure of product labeling + Experience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneously + Ability to work independently or in teams, globally. Ability to lead broad range of stakeholders at all levels internally and externally to the company. + Effective written and oral communication and organizational skills + Strong attention to detail + Solid aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications + Ability to think strategically, communicate risks, and recommend problem solving innovative solutions + Ability to recognize and escalate issues + The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams. **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 Associate Director (AD), Federal Government Affairs, will assist in the development, communication, and deployment of Otsuka's federal strategies, engagement activities and policy priorities that promote access to therapies, preserve patient/provider choice, and generally protect Otsuka's business interests in policy areas impacting Mental Health, Nephrology, Immunology, and Rare Disease. This role reports directly to the Director, Federal Government Affairs and located in the Washington, DC area. The Associate Director will leverage Otsuka's resources including Otsuka US Political Action Committee (OUSPAC), trade associations and consultants to advance company policy positions. The AD will also work strategically to help advance, defeat or mitigate decisions or actions by the U.S. Congress and Administration that could negatively or positively affect our business or patients. Accountable for building and maintaining relationships with key members and staff of U.S. Congress as well as political appointees within an Administration, including communicating, advocating and direct lobbying of Otsuka policy positions. **** **Key responsibilities** + Monitor and analyze proposed and emerging federal legislation/regulation to determine its impacts on Otsuka business and the industry; help determine the most effective strategies to advance business priorities in coordination with the Government Affairs & Public Policy Leadership Team + Work in collaboration with the Director, Federal Government Affairs, to develop and implement federal strategies to achieve favorable results + Responsible for the successful execution of Otsuka's federal legislative goals, corporate initiatives, and internal business goals, and ensure focus to achieve these priorities + Interact with federal policy decision-makers and influencers, advocacy leaders, relevant committee chairs, members, support staff and others relevant officials regarding issues impacting access to care within the health care delivery system, in accordance with Otsuka strategic objectives + Help raise profile of Otsuka within various communities, including advocacy, political, and trade associations; seek out and serve in volunteer leadership roles to advance professional development and business objectives + Conduct all activities in compliance with all applicable federal laws and regulations and company policies **Expectations** + Share relevant information freely, seek collaboration and input where appropriate; Achieve results with and through others across Gov't Affairs & Public Policy and the greater Corporate Affairs + Individual capable of identifying relevant public policy issues and implementing comprehensive plans to both protect and advance the interests of the Company + Effective communicator with strong presentation skills with the ability to interact with both external and internal audiences. + Demonstrate effective working relationships both within and outside of the team. **Qualifications/ Required** Knowledge/ Experience and Skills: **Qualifications** + 5+ years of relevant legislative experience, primarily in healthcare, including working with the federal branch and/or Congress ; or 5+ years diverse background in the pharmaceutical industry, with at least 5 years in government affairs required + Bachelor's degree required. Advanced degree in law, health policy or MBA preferred + Ability to effectively deliver information, and explain, advocate and negotiate positions and issues to a broad spectrum of individuals required + Strong work ethic with ability to handle a fast-paced, vigorous schedule; comfortable with shouldering and assessing risk. + In depth understanding of healthcare, pharmaceutical and biotechnology industry issues required + Demonstrated track record of strong advocacy and communication skills + Ability to forge consensus, take others' viewpoints into account, and work as part of a team + Strong organizational, planning, strategic thinking, and people management skills + Independent thinker who can diplomatically and articulately present ideas that may be different from the prevailing or conventional views + Experience working with diverse coalitions and adeptness in developing and facilitating strategy across a network of internal and external partners **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. **Equal Opportunity Employer** 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 $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 Associate Director, Strategic Planning & Operations will support the assets of varying lifecycle stages in the relevant therapeutic area portfolio. This role is crucial in driving operational excellence and innovation within our Global Medical Affairs organization, with a specific focus on the relevant therapeutic area programs. The successful candidate will play a pivotal role in shaping and implementing best practices and ensuring efficient medical affairs processes are in place. This position reports directly into the Director, Strategic Planning Lead, who in turn reports into the Medical Excellence & Operations Lead. **** **Key Responsibilities Include:** **Strategic Planning & Execution** + Develop and implement strategic plans in partnership with Medical Strategy leadership to enhance operational efficiency and effectiveness within the GMA organization for the relevant therapeutic area portfolio + Collaborate with cross-functional teams to align global medical operations with overall business objectives and therapeutic area strategies + Act as point lead (in collaboration with commercial) to coordinate annual medical/brand plans for the relevant therapeutic area portfolio + Drive long-term planning for the CNS portfolio by managing a 1 to 3-year roadmap that supports strategic decision-making and cross-functional collaboration + Oversee end-to-end program management processes, including planning, tracking, and reporting across key initiatives **Operational Efficiency and Process Improvement** + Identify opportunities for process improvement and lead initiatives to streamline GMA operations worldwide + Implement and optimize systems and tools to enhance productivity and data management within GMA + Develop and track key performance indicators (KPIs) to measure the effectiveness of global medical operations + Consider technology and AI to support workflow improvement **Cross-functional Collaboration** + Foster strong partnerships with Global Clinical Development, Global R&D Evidence, Commercial teams, & finance to ensure alignment and efficiency in medical activities + Collaborate with IT and digital teams to implement and optimize technology solutions for global medical operations + Serve as a liaison between Global Medical Affairs and other departments to facilitate smooth operations and communication across regions **Budget Management** + Develop and manage day to day aspects of budgets for global medical operations initiatives + Ensure cost-effective utilization of resources while maintaining high-quality outputs across all regions + Serve as a strategic thought partner who confidently challenges investment decisions, ensuring alignment with broader organizational strategy and long-term value creation + Foster a culture of continuous improvement of fiscal stewardship within the global team **Qualifications** **Education and Experience:** + Bachelors degree required, advanced degree in life sciences, pharmacy, or related field (Ph.D., PharmD) a plus + Minimum of 7 years of experience in Global Medical Affairs within the pharmaceutical or biotechnology industry, with at least 3 years in operational roles + Proven track record in implementing process improvements and driving operational excellence on a global scale **Skills and Competencies:** + Strong understanding of Global Medical Affairs functions and their interconnections with other departments + Technical knowledge in Veeva CRM, Veeva Vault, KOL Mapping Systems, etc. + Excellent project management skills with the ability to manage multiple global initiatives simultaneously + Strong leadership skills with the ability to influence without direct authority across global teams + Exceptional communication and interpersonal skills, with the ability to work effectively in a multicultural environment + Innovative mindset with the ability to identify and implement creative solutions for global challenges **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 Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the impact of regulatory changes to the pharmaceutical environment. **** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated regulations and guidance that may impact pharmaceutical practices, procedures and controlled documents. + Lead weekly regulatory intelligence team meetings to include review and discussion of ad hoc query requests, regulatory background package requests, health authority guidance, Federal Register notices, public commenting opportunities, and newsletter content. + Manage development and distribution of weekly regulatory intelligence newsletters and regulatory watch notifications. + Ensure regulatory intelligence specialists have continued access to regulatory, clinical trial, and public domain information resources to identify relevant regulatory-related news and information, and competitor product regulatory developments and report the most critical findings. + Discuss and triage any technical issues with the reg intel platform, access requests, and distribution issues. + Demonstrate comprehensive understanding of AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize regulatory intelligence information. + Monitor organizational strategic priorities and participate in cross-departmental discussions to consistently capture relevant and targeted regulatory intelligence. + Regularly review and update AI taxonomy terms relevant to Otsuka approved and investigational products, clinical, and business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen and support Otsuka as a learning organization. + Maintain close communication with Informational Technology, Regulatory Technology, and the software vendor to maintain optimal functioning of the regulatory intelligence technology platform. + Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated guidance and regulations. + Lead regulatory public commenting process and posting of Otsuka comments to health authority websites. + Review and update Regulatory Intelligence homepage on GRA Collaboration Portal. + Manage onboarding and offboarding of regulatory intelligence team members, provide input on team member performance, establish annual budget, and manage spend. + Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices. + Review overall quality of ad hoc query research for requested regulatory topics and confirm acceptability of responses. + Demonstrate understanding of the major regional and global industry association priorities (e.g., PhRMA, EFPIA, JPMA, etc.). + Demonstrate solid working knowledge of the drug, biologic, and device development process, laws, regulations, and guidelines from FDA, EMA, PMDA, ICH, etc. + General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products. + Confirm list of upcoming regulatory meetings/workshops/conferences remains current. **Qualifications** + Master's degree in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and Competencies:** + Demonstrates the ability to plan, direct, organize, and coordinate projects. + Demonstrates experience interacting with and supporting senior leadership. + Previous experience with people management and team leadership. + Excellent interpersonal and communication skills, both written and verbal. + Previous experience developing newsletters is desirable. + Results driven and team-oriented collaborative approach required. + Critical thinking and problem-solving skills. + Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook). **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.

**Associate Director, Field Strategy, Nephrology/Immunology** The **Associate Director, Field Strategy** plays a critical role in enabling **sales execution** by ensuring that field teams have the **clarity, insights, and tools** needed to drive performance. This role is responsible for aligning **key metrics and insights** **with brand strategy** , ensuring that analytics dashboards and reporting tools provide **actionable, field-relevant intelligence** - ensures insights are turned into action. Rather than creating new tools, data, or systems, this individual **orchestrates the seamless integration and application** of existing resources, ensuring field teams can focus on **flawless execution of sales strategy** . They ensure field teams are fully informed, equipped, and leveraging all available tools, insights, and strategic initiatives to maximize impact. This position provides **strategic support across multiple regions** , partnering closely with **sales leadership nationwide** to ensure a broad perspective on **performance trends and execution effectiveness** . Additionally, the role collaborates with **Business Analysis team** to ensure field teams have access to **actionable insights and a consistent reporting framework** that drives informed decision-making at a national, regional, and territory level. **Key responsibilities:** + **Define & Measure Field Impact:** + Establish **KPIs** that align with brand strategy to measure the field's effectiveness in driving business outcomes. + Develop **frameworks** to assess whether field teams are successfully executing strategic priorities + **Standardize Performance Tracking & Reporting** + Ensure **consistency in national and subnational tracking** of field performance and execution through standardized dashboards. + Partner with Commercial Operations to **streamline reporting processes** and provide clear, actionable insights + **Drive Strategic Clarity and Field Engagement & Execution** + Ensure that **brand strategy is effectively translated into field execution** , with clear expectations at the national, regional, ecosystem, and territory levels + Act as a strategic partner to sales leadership, ensuring that field insights inform future strategic decisions + Ensure field teams understand the **"why" behind initiatives** , fostering strong alignment with broader commercial objectives. + **Lead Business Review Framework & Execution** + Own the **business review process framework** , ensuring a standardized approach that addresses key strategic questions from senior leadership. + Develop clear templates and storytelling approaches to ensure **business reviews provide meaningful insights and drive decision-making** + **Support Business & Account Planning** + Ensure that **business and account plans are created effectively** and that key stakeholders (e.g., SBDs, ELs, HSAs) are accountable for execution. + Monitor plan execution and provide feedback to optimize performance at all levels + **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 7 years of pharmaceutical experience + 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 preferred + Proven experience in data analysis, business intelligence, and strategic planning within a pharmaceutical sales environment + Strong ability to distill data into concise, actionable insights to drive business performance + Excellent communication and stakeholder engagement skills, with the ability to influence and align across multiple teams Proven ability to collaborate with cross **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 $153,700.00 - Maximum $229,770.00, 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 Associate Director, GxP Training, is a critical member of the Learning Center of Excellence within Global Quality. This role is responsible for developing and maintaining robust training programs that ensure compliance with Good Practice (GxP) regulations across the organization. The position will lead the design, implementation, and governance of global learning strategies that support regulatory readiness, operational excellence, and a strong quality culture. **Key Responsibilities:** + **Learning Strategy & Governance** + Define and execute the global GxP training strategy in alignment with regulatory requirements and corporate quality objectives. + Establish governance frameworks for training compliance, including policies, procedures, and audit readiness. + **Program Development & Delivery** + Design and oversee GxP training programs for diverse functions (e.g., R&D, Manufacturing, Quality, Clinical, and Commercial). + Develop innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches. + **Compliance & Risk Management** + Ensure all training programs meet global regulatory standards (FDA, EMA, ICH, etc.) and internal SOPs. + Monitor training compliance metrics and proactively address gaps to mitigate regulatory risk. + **Stakeholder Collaboration** + Partner with functional leaders, Quality Systems, and HR to align training initiatives with business needs. + Serve as a subject matter expert on GxP learning during audits and inspections. + **Continuous Improvement & Analytics** + Define KPIs and utilize data analytics to measure training effectiveness and drive continuous improvement. + Stay current with regulatory changes, industry trends, and emerging technologies to evolve training programs. **Qualifications:** + Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred. + 8+ years of experience in learning and development, preferably within the pharmaceutical, biotech, or healthcare industry with a focus on GxP compliance and training. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). + Proven ability to design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. + Expertise in instructional design, adult learning principles, and digital learning technologies. + Excellent communication, stakeholder management, and project leadership skills. **Preferred Attributes:** + Strategic thinker with a passion for scientific learning and development. + Agile and adaptable in a fast-paced, matrixed environment. + Strong project management and organizational skills. + Committed to fostering innovation, compliance, and continuous improvement through learning. **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 $146,955.00 - Maximum $219,650.00, 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 Associate Director will serve as a key member of the Learning Center of Excellence within Global Quality, responsible for designing, implementing, and sustaining high-impact training programs for Commercial and General & Administrative (G&A) functions. This role ensures that learning strategies align with regulatory requirements, corporate standards, and business objectives, fostering a culture of compliance, quality, and continuous improvement across global operations **Key Responsibilities:** + **Learning Strategy & Design** + Develop and execute a comprehensive training strategy for Commercial and G&A teams in alignment with Global Quality standards and business priorities. + Partner with functional leaders to identify learning needs, compliance gaps, and performance improvement opportunities. + **Program Development & Delivery** + Design engaging, scalable, and compliant learning solutions (e.g., instructor-led, virtual, e-learning) tailored to diverse audiences. + Oversee the creation and maintenance of training content, ensuring accuracy, relevance, and adherence to regulatory guidelines. + **Governance & Compliance** + Ensure all training programs meet global regulatory requirements and internal quality standards. + Monitor training effectiveness and maintain audit-ready documentation for inspections. + **Stakeholder Engagement** + Collaborate with cross-functional teams, including Commercial, HR, Legal, and IT, to drive adoption and continuous improvement of learning initiatives. + Act as a trusted advisor to senior leadership on training trends, compliance risks, and capability-building strategies. + **Metrics & Continuous Improvement** + Define KPIs and leverage data analytics to measure training impact and drive enhancements. + Stay current with industry best practices, emerging technologies, and regulatory changes to evolve learning programs **Qualifications:** + Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred. + 8+ years of experience in learning and development, preferably within the pharmaceutical, biotech, or healthcare industry. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). + Proven ability to design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. + Proven experience designing and implementing global training programs for Commercial and G&A functions. + Expertise in instructional design, adult learning principles, and digital learning technologies. + Excellent communication, stakeholder management, and project leadership skills. **Preferred Attributes:** + Strategic thinker with a passion for scientific learning and development. + Agile and adaptable in a fast-paced, matrixed environment. + Strong project management and organizational skills. + Committed to fostering innovation, compliance, and continuous improvement through learning. **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 $146,955.00 - Maximum $219,650.00, 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 Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's global network of contract manufacturing organizations (CMOs). This role supports the qualification, monitoring, and compliance of external manufacturing partners to ensure the quality and reliability of pharmaceutical products, including small molecules and biologics. **** + **Supplier Quality Execution** + Support the qualification and ongoing monitoring of CMOs and critical suppliers. + Execute supplier audits and ensure timely follow-up and resolution of findings. + Maintain and update quality agreements in collaboration with internal stakeholders. + Conduct risk assessments and support mitigation plans for supplier-related quality issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (e.g., FDA, EMA, ICH). + Prepare documentation and support internal and external audits and inspections. + Maintain accurate records of supplier performance and audit outcomes. + **Cross-Functional Collaboration** + Collaborate with Procurement, Manufacturing, Regulatory Affairs, and Technical Operations to ensure supplier quality is integrated into business processes. + Serve as a point of contact for operational supplier quality issues and escalations. + **Metrics & Reporting** + Track and report key performance indicators (KPIs) related to supplier quality. + Provide regular updates to leadership on supplier performance and compliance status **.** + **Team & Project Support** + May supervise or mentor junior quality staff or contractors. + Support continuous improvement initiatives within the supplier quality function. **Qualifications** Required + Bachelor's degree in a scientific or engineering discipline. + 6+ years of experience in pharmaceutical quality, with 2+ years in supplier or external manufacturing quality. + Strong knowledge of GMP regulations for small molecules and/or biologics. + Experience conducting audits and managing supplier documentation. + Strong communication and problem-solving skills. + Ability to travel internationally as needed. Preferred + Experience working with global CMOs. + Familiarity with digital tools and systems for supplier management. + Exposure to regulatory inspections and remediation activities. **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 $146,955.00 - Maximum $219,650.00, 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 Associate Director, Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role will direct Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **** + Responsible for directing quality oversight of GMP contract manufacturers of Otsuka clinical and commercial products. + Develops comprehensive quality strategies for complex biologic development programs that address unique manufacturing challenges. + Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product). + Transforms biologic manufacturing quality challenges through innovative approaches that maintain product integrity while optimizing operational efficiency. + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance. + Manages reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests. + Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above. + Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. + Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc. + Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP. + Assists in conducing audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable regulatory requirements. + Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met. + Serves as a Global Quality Product Champion with a focus on ensuring the quality of our biologics products, monitoring, and escalation of any situations with potential negative impacts on clinical study supplies, supply chain for commercial products, or patient safety. **Qualifications** Required + Bachelor's degree in Chemistry, Biology or other Physical Sciences. + Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial product and development project activities. + Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects. + Proven experience with biologics GMP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes. + Expertise in conducting root cause investigations and driving CAPA implementation. + Ability to supervise multiple direct reports and projects in a fast-paced environment. + Demonstrated success in working on and leading cross functional teams. + Experience with Pre Approval Inspections for NDAs and BLAs. + Experience in driving continuous improvement projects. + TrackWise Experience. + Excellent interpersonal and communication skills. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Advanced degree in Biology or other Physical Sciences. + Experience with quality oversight of controlled substances. **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 $146,955.00 - Maximum $219,650.00, 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 Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight of clinical and commercial controlled substances manufactured at CMOs under contract by Otsuka. This role is responsible to ensure that clinical and commercial products that may be classified as controlled substances are manufactured, packed, labelled, stored, and transported accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **** + Responsible for directing quality oversight of GMP contract manufacturers of controlled substances for Otsuka clinical and commercial products + Support cross-functional teams to ensure alignment and compliance with controlled substance regulations. + Provides guidance and expertise to sites and business units to assess the facilities, and/or business operations, compliance of DEA regulations and site procedures. + Managing, updating and improvements of corporate controlled substance oversight standards. Provide oversight to ensure inspections readiness. + Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product) for controlled substances + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance + Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above Improves supplier quality performance for batch record review and release process for + OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. + Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc. + Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP + Assists in conducing audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable controlled substance regulatory requirements + Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met **Qualifications** Required + Bachelor's degree in Chemistry, Biology or other Physical Sciences + Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial and development controlled substances. + Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects. + Expertise in conducting root cause investigations and driving CAPA implementation + Ability to supervise multiple direct reports and projects in a fast-paced environment + Demonstrated success in working on and leading cross functional teams + Experience with Pre Approval Inspections for NDAs + Experience in driving continuous improvement projects + TrackWise Experience + Excellent interpersonal and communication skills + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Advanced degree in Chemistry or other Physical Sciences **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 $146,955.00 - Maximum $219,650.00, 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 Compliance Associate Director assists in implementing and further enhancing the anti-corruption/anti-bribery Compliance program. Reporting to the Executive Director Head of Global Compliance Program Strategy, Assurance and Management, the Compliance Associate Director will be responsible for executing compliance-related investigations and supporting the company's global healthcare fraud and abuse assurance program and activities, including auditing and monitoring, both transactional and live. The Compliance Associate Director will serve as the initial point of contact for business colleagues for these activities, will support department initiatives globally and must have knowledge of the biotechnology/pharmaceutical industry, anti-bribery/anti-corruption laws, and experience executing compliance-related investigations as well as assurance activities. Key Duties and Responsibilities: Develops, implements, and continuously improves global auditing and monitoring plan. Sharing auditing and monitoring results with business partners, and recommending corrective actions. Identifying and tracking themes and trends across audits and/or monitoring; preparing presentations to share results with OBIE leadership and the business. Manage and triage matters that come through the internal compliance Alert-Line tool and/or OBIE directly. Lead and support in the discrete and professional execution of compliance-related investigations. Collaborate with HR and Litigation colleagues in relation to compliance-related investigations. Develop compliance related training content Develops and maintains strong relationships with OBIE Business Partners, Internal Audit, Legal, as well as colleagues in other functional areas across the global organization. Maintains high level of knowledge of current and emerging laws and regulations and recent enforcement actions and inform and educate business units with tailored communications. Support continuous improvement of the Global Compliance Program. Knowledge and Skills: Deep knowledge of risk assessment and mitigation as well as auditing and monitoring. Demonstrated ability to identify and mitigate risk. Healthcare fraud and abuse auditing and monitoring experience, with preference for experience in the biotechnology/pharmaceutical industry. Ability to develop and implement auditing and monitoring and other assurance activities and meet internal reporting requirements. Strong communication, presentation, collaboration, and influencing skills. Consummate team player with excellent judgment and interpersonal skills. Ability to communicate effectively with all levels of employees. Demonstrable experience taking ownership of projects and driving execution. Strong oral and written communication skills and the ability to collaborate cross-functionally. Strong analytical, organizational, and problem-solving skills. Excellent project management skills with the ability to manage multiple priorities simultaneously. Self-starter with demonstrated ability to meet goals; able to exercise sound judgment in escalating matters appropriately. Ability to work with large amounts of data to analyze information while still seeing the “big picture”. Investigation workplan development and investigative interviewing experience, with preference for experience in the biotechnology/pharmaceutical industry. Confidence and professionalism to handle difficult conversations and discretion on sensitive matters. Knowledge of biotech/pharmaceutical industry regulations, applicable local codes, and anti-bribery/anti-corruption laws and extensive experience working for biotechnology/pharmaceutical companies on these issues. Education and Experience: Bachelor's degree Typically requires 7 to 10 years experience focused on biotech or pharmaceutical industry in private practice/consulting, in-house, or a combination, or the equivalent combination of education and experience. Ability to travel approximately 15-20% of time. CPA, CFE or JD preferred Experience with anti-bribery/anti-corruption laws and pharmaceutical regulations and guidances preferred Operations and project management experience. Demonstrated strong commitment to compliance, ethics, and accountability. Flexibility to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude. Proficiency in MS Office (especially XLSX and PPT). Advanced English language skills. #LI-DB1 #LI-HYBRID Pay Range: $166,500 - $249,800 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Vertex is seeking to hire an Associate Director, NA Cystic Fibrosis (CF) Analytics & Reporting to join the North America Forecasting, Analytics, and Insights team in the Commercial organization. This role will provide analytics support for strategic commercial initiatives by identifying and quantifying market drivers, barriers, and opportunities using advanced analytical methods. Additionally, this role will provide support for ongoing analytics, quantitative tracking, and reporting of national and sub-national commercial performance of the NA CF business. This individual will work cross-functionally and lead requirement gathering, development, execution, and insight generation for performance analytics, dashboards, and present insights to stakeholders. The ideal candidate must be a skilled, experienced individual contributor and demonstrate the ability to communicate complex concepts to a wide variety of stakeholders. This candidate must possess a high degree of attention to detail and accuracy in creating deliverables and must be self-directed in engaging with colleagues. Additionally, this candidate must be able to strategize, collaborate, and manage relationships with our many cross-functional partners. Key Duties and Responsibilities: * Work with CF BU stakeholders to identify existing or planned initiatives that would benefit from additional analytics support, and collaboratively create and execute analytics plans to deliver actionable insights * Design & operate an analytical engine to identify & quantify drivers, barriers, and opportunities in the market using advanced statistical / ML methodology * Lead commercial KPI tracking, reporting, and analytics processes end-to-end, with primary focus on US CF (e.g., working with IT partners to develop Power BI dashboards, prepare PPT presentations, or other similar materials) * Contribute to answering ad-hoc analytics questions as they arise from the BU and other stakeholders; work to understand questions and define appropriate data & analytics approaches * Develop and leverage deep understanding of available data sets, and work with partners to ingest, process, and analyze data for reporting and analytics * Generate and deliver actionable insights to key stakeholders, including collaborating with other analytical partners at Vertex * Work collaboratively with cross-functional stakeholders, including but not limited to US Marketing, Global Marketing, US Market Access, US Finance, and Commercial Sales Operations Knowledge and Skills: * Proficiency with complex Excel modeling, and analyzing and developing insights from large data sets, leveraging relevant tools such as SQL, python, SAS, VBA, etc. * Proficiency working with wide array of commercial pharma data sets, including data sets such as IQVIA (or equivalent from different data vendor), patient claims data, and internally generated sales / marketing data (e.g. field call data from CRM) * Experience building and maintaining KPI reporting dashboards within the pharma/biotech industry, using tools such as Power BI * Strong analytical and business acumen: intellectual curiosity, motivation and ability to structure problems, diagnose issues and triangulate with multiple approaches while keeping sight of the "big picture" * Experience working with senior leadership to support insights generation and communication, financial forecasting and analytics, and/or commercial launch planning * Ability to quickly and thoughtfully adapt to new and evolving business and planning needs Education and Experience: * Master's degree in a quantitative discipline required (Engineering, Statistics, Economics, Finance, Science) or equivalent experience * 7-10 years in biotech/pharmaceuticals in a quantitative role in Commercial / Corporate Strategy / BD, and/or 4 years in a relevant consulting role (management, strategic or economic consulting) post-MBA/PhD, with meaningful biotech/pharmaceuticals and quantitative decision support experience. Pay Range: $157,800 - $236,700 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

The Associate Director, Strategy and Operations, US Market Access is a key partner and advisor to the VP US Market Access and Market Access Leadership Team (MALT) on a variety of strategic, operational, and organizational matters. The role requires both strategic thinking as well as the ability to drive operational execution through preparing, implementing, and effectively managing tactical initiatives. The ideal candidate is a highly motivated and highly organized individual with exceptional emotional intelligence, communication skills and judgment with the ability to manage complex details, understand the business, and drive action. This role reports directly into the Vice President of US Market Access. Key Responsibilities: * Support the US MALT in developing and implementing decisions impacting team operations and strategic direction for the US Market Access team * Support the VP in defining and developing high-impact executive, cross-functional and cross-team communications * Develops and maintains department budget in collaboration with the leadership team and finance to provide transparency into spend, understand and explain forecast variance, and manage tools to ensure maximization of budget * Lead or support critical business processes relevant to US Market Access, including evolution of organizational design, Long Range Planning and annual Business Planning * Lead and/or manage special projects and high-profile initiatives, as appropriate and aligned with critical business needs * Quarterback development of Business Reviews, senior management presentations, team presentations and meetings * Enhance processes for measuring and reporting progress on high-priority initiatives across the USMA team * Lead after action reviews of high impact projects; provide recommendations for simplification of processes and systems. Identify and plan proactively address business needs to ensure success of team. * Coordinate leadership team meetings and forums such as offsites and pull through of action items Ideate and coordinate pull-through of HR, talent development, and team-culture related initiatives and activities * Contributes to the best practices of project management and departmental operations to support the continued success and evolution of the department * Act as a liaison between cross functional colleagues to ensure alignment and coordination on a wide variety of cross-functional initiatives Qualifications: * Bachelor's degree required * 8+ years of progressive, relevant experience with demonstrated experience as a chief of staff, in project management, or organizing and directing multiple teams and departments * Outstanding communication of information and ideas, both written and verbal, to diverse audiences; employs active listening skills * Strong collaboration skills, with an ability to influence multiple stakeholders; builds mutual trust, respect and cooperation among team members * Significant experience in managing complex project teams and proven ability to work in and influence a cross-functional team; solution-oriented mindset * Excellent analytical and financial business planning skills * Self-motivated; acts independently and prioritizes appropriately; embraces unexpected changes or challenges and drives to improved solutions Pay Range: $155,700 - $233,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

The Associate Director, Strategy and Operations, US Market Access is a key partner and advisor to the VP US Market Access and Market Access Leadership Team (MALT) on a variety of strategic, operational, and organizational matters. The role requires both strategic thinking as well as the ability to drive operational execution through preparing, implementing, and effectively managing tactical initiatives. The ideal candidate is a highly motivated and highly organized individual with exceptional emotional intelligence, communication skills and judgment with the ability to manage complex details, understand the business, and drive action. This role reports directly into the Vice President of US Market Access. Key Responsibilities: Support the US MALT in developing and implementing decisions impacting team operations and strategic direction for the US Market Access team Support the VP in defining and developing high-impact executive, cross-functional and cross-team communications Develops and maintains department budget in collaboration with the leadership team and finance to provide transparency into spend, understand and explain forecast variance, and manage tools to ensure maximization of budget Lead or support critical business processes relevant to US Market Access, including evolution of organizational design, Long Range Planning and annual Business Planning Lead and/or manage special projects and high-profile initiatives, as appropriate and aligned with critical business needs Quarterback development of Business Reviews, senior management presentations, team presentations and meetings Enhance processes for measuring and reporting progress on high-priority initiatives across the USMA team Lead after action reviews of high impact projects; provide recommendations for simplification of processes and systems. Identify and plan proactively address business needs to ensure success of team. Coordinate leadership team meetings and forums such as offsites and pull through of action items Ideate and coordinate pull-through of HR, talent development, and team-culture related initiatives and activities Contributes to the best practices of project management and departmental operations to support the continued success and evolution of the department Act as a liaison between cross functional colleagues to ensure alignment and coordination on a wide variety of cross-functional initiatives Qualifications: Bachelor's degree 8+ years of progressive, relevant experience with demonstrated experience as a chief of staff, in project management, or organizing and directing multiple teams and departments Outstanding communication of information and ideas, both written and verbal, to diverse audiences; employs active listening skills Strong collaboration skills, with an ability to influence multiple stakeholders; builds mutual trust, respect and cooperation among team members Significant experience in managing complex project teams and proven ability to work in and influence a cross-functional team; solution-oriented mindset Excellent analytical and financial business planning skills Self-motivated; acts independently and prioritizes appropriately; embraces unexpected changes or challenges and drives to improved solutions Pay Range: $155,700 - $233,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

The Associate Director is recognized as an expert in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. This role is responsible for oversight and coordination of GMP activities in support of Commercial Release and serves as primary QA contact on cross-functional teams. The Associate Director manages and develops personnel and support department and functional activities. KEY DUTIES AND RESPONSIBILITIES: The responsibilities of this role may include, but are not limited to, the following: * Responsible for oversight of analytical activities in support of release of commercial products. * Collaborates with internal and external business partners to resolve complex quality issues to ensure compliant solutions in support of Analytical QA function. * Represents Analytical QA function at meetings with CMO/CTL/Suppliers. Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex. Supports inspection readiness and vendor management teams as needed. * Guides and conducts quality investigations, OOS/OOT investigations, deviations. Communicate any risks and gaps to management as known. * Reviews investigation reports and corrective action plans for adequacy and compliance. This includes escalation assessment, root cause analysis and product impact assessments for investigations resulting from deviations and OOS. May serve as an Escalation Lead. * Ensures appropriate CAPA actions are identified/evaluated and approves investigations/CAPA plans/actions. * Assesses and approves Change Controls. * May generate and analyze Laboratory Controls and other metrics for Operational Reviews, QLT's and QMR's. May provide support to Laboratory Control PON. * Provides support to implementation of QMS as relevant to Analytical QA functions. * Provides support to QA management with process improvement activities. Identifies and facilitates continuous improvement efforts and leads continuous improvement projects as assigned. * Provides tactics to address compliance gaps or determines enhancements to cross-functional quality systems. * Conducts review of procedures, SOP's and work instructions. * Supports and conducts data review and COA generation as needed. * Provides back-up support for other projects when needed. Assists with internal audits and external regulatory agency inspections when needed. * Responsible for the following activities related to people management responsibilities. o Talent Development and Coaching o Performance Management (goals, monitoring, reviews) o Monitoring /Supporting Employee Engagement o Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs o Accountable to provide oversight of day-to-day operations o Assists with workforce planning/resource modeling PREFERRED QUALIFICATIONS: * Broad GxP Knowledge across Product lifecycle. In-depth knowledge of global GMP requirements. * Ability to think critically and strategically with clear goals in mind. * Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives * Demonstrated ability to manage teams and to develop personnel. Demonstrated ability to mentor and guide staff and transfer technical knowledge and teaching quality management skills. * Demonstrated ability to work independently to provide QA advice for large, multifaceted * Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement and the analysis/synthesis of a variety of information; ability to work outside of precedent and takes a new perspective on existing solutions. * Ability to communicate cross-functionally to a wide variety of audiences, question stakeholders to understand their needs. * Successful track record influencing cross functional teams and gain alignment on proposed actions * Strong experience in leading Quality Events investigations, Root Cause Analysis (RCA), and CAPA implementation. * Demonstrated ability to independently lead cross-functional teams and to provide QA advice for large, multifaceted projects. * Strong laboratory/QC experience and understanding of various analytical techniques. * Ability to effectively organize and plan activities. * Experience in Presentations and Risk Management. * Operational QA experience in analytical or manufacturing setting is desired. EDUCATION AND EXPERIENCE: * Master's degree and 5-8 years of work experience in a scientific or allied health field, or Bachelor's degree in a scientific or allied health field and 10+ years of relevant work experience, or relevant comparable background We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work: 1. Hybrid and work remotely up to two days per week; or select 2. On-Site and work 5 days per week with ad hoc flexibility. #LI-AR1 #LI-Hybrid Pay Range: $152,200 - $228,300 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

The Associate Director is recognized as an expert in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. This role is responsible for oversight and coordination of GMP activities in support of Commercial Release and serves as primary QA contact on cross-functional teams. The Associate Director manages and develops personnel and support department and functional activities. KEY DUTIES AND RESPONSIBILITIES: The responsibilities of this role may include, but are not limited to, the following: • Responsible for oversight of analytical activities in support of release of commercial products. • Collaborates with internal and external business partners to resolve complex quality issues to ensure compliant solutions in support of Analytical QA function. •Represents Analytical QA function at meetings with CMO/CTL/Suppliers. Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex. Supports inspection readiness and vendor management teams as needed. •Guides and conducts quality investigations, OOS/OOT investigations, deviations. Communicate any risks and gaps to management as known. •Reviews investigation reports and corrective action plans for adequacy and compliance. This includes escalation assessment, root cause analysis and product impact assessments for investigations resulting from deviations and OOS. May serve as an Escalation Lead. • Ensures appropriate CAPA actions are identified/evaluated and approves investigations/CAPA plans/actions. •Assesses and approves Change Controls. •May generate and analyze Laboratory Controls and other metrics for Operational Reviews, QLT's and QMR's. May provide support to Laboratory Control PON. •Provides support to implementation of QMS as relevant to Analytical QA functions. •Provides support to QA management with process improvement activities. Identifies and facilitates continuous improvement efforts and leads continuous improvement projects as assigned. •Provides tactics to address compliance gaps or determines enhancements to cross-functional quality systems. •Conducts review of procedures, SOP's and work instructions. •Supports and conducts data review and COA generation as needed. •Provides back-up support for other projects when needed. Assists with internal audits and external regulatory agency inspections when needed. •Responsible for the following activities related to people management responsibilities. o Talent Development and Coaching o Performance Management (goals, monitoring, reviews) o Monitoring /Supporting Employee Engagement o Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs o Accountable to provide oversight of day-to-day operations o Assists with workforce planning/resource modeling PREFERRED QUALIFICATIONS: •Broad GxP Knowledge across Product lifecycle. In-depth knowledge of global GMP requirements. •Ability to think critically and strategically with clear goals in mind. •Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives •Demonstrated ability to manage teams and to develop personnel. Demonstrated ability to mentor and guide staff and transfer technical knowledge and teaching quality management skills. •Demonstrated ability to work independently to provide QA advice for large, multifaceted •Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement and the analysis/synthesis of a variety of information; ability to work outside of precedent and takes a new perspective on existing solutions. •Ability to communicate cross-functionally to a wide variety of audiences, question stakeholders to understand their needs. •Successful track record influencing cross functional teams and gain alignment on proposed actions •Strong experience in leading Quality Events investigations, Root Cause Analysis (RCA), and CAPA implementation. •Demonstrated ability to independently lead cross-functional teams and to provide QA advice for large, multifaceted projects. •Strong laboratory/QC experience and understanding of various analytical techniques. •Ability to effectively organize and plan activities. •Experience in Presentations and Risk Management. •Operational QA experience in analytical or manufacturing setting is desired. EDUCATION AND EXPERIENCE: •Master's degree and 5-8 years of work experience in a scientific or allied health field, or Bachelor's degree in a scientific or allied health field and 10+ years of relevant work experience, or relevant comparable background We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work: 1. Hybrid and work remotely up to two days per week; or select 2. On-Site and work 5 days per week with ad hoc flexibility. #LI-AR1 #LI-Hybrid Pay Range: $152,200 - $228,300 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Vertex is seeking a hands-on, experienced team member with a passion for transformation and bringing new capabilities to our organization. The Associate Director, Accounting Transformation will manage and support initiatives that will modernize, streamline, and enhance processes impacting the Accounting and Finance teams. This new role is ideal for a motivated individual who thrives on working on meaningful projects while bringing stakeholders along through all facets of the journey. Key Duties and Responsibilities: * Manage daily aspects of various transformation projects while keeping deliverables on track to meet agreed upon timelines. * Drive analysis of large data sets and provide clear interpretations as a result. * Engage with appropriate stakeholders to ensure reporting impacts are well understood, documented and addressed effectively. * Collaborate with cross-functional teams to analyze and document current and future state process workflows * Develop and execute strategy for testing system implementation and process updates, with a focus on transactional testing through reporting in a SOX compliant manner. * Partner closely with DTE, Accounting, Finance and other stakeholders, including any 3rd party vendors on gathering and finalizing requirements and cross functional resources needed * Implement best practices in financial reporting, internal controls, and compliance to ensure accuracy and consistency of accounting records * Assist with change management efforts to ensure the successful adoption of new systems, tools, and/or processes * Effectively communicate with and train stakeholders on any new tools or processes as needed Knowledge and Skills: * Demonstrated transformation experience with complex integrated transactional and reporting systems. Oracle EBS and Hyperion Essbase knowledge strongly preferred. * Understanding of accounting transactional system workflows and accounting principles. * Solid understanding of data movement into various reporting layers and hierarchies * Reporting enhancements including requirements gathering and functional design documents. * Possesses solid interpersonal and organizational skills with an understanding of Lean principles and project management terminology. * Able to anticipate change and leading by example with a "can do" attitude. * Excellent written and verbal communication skills including the ability to succinctly convey relevant information across multiple levels of the organization. * Strong understanding of internal controls and compliance requirements. * Knowledge of Tax and Treasury terminology a significant plus Education and Experience: * Bachelor's degree in either Accounting, Finance, Information Technology, Business or a related field * Typically requires 10+ years of experience in finance or accounting with a large, complex, multinational organization * Project experience leading and/or supporting transformational initiatives * Experience with transactional system design and testing * Life science industry experience is preferred * A track record of success working in a team-based environment * Experience with SmartView, RPA BOTS, and latest AI advancements is preferred #LI-HYBRID Pay Range: $144,000 - $216,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Vertex is seeking a hands-on, experienced team member with a passion for transformation and bringing new capabilities to our organization. The Associate Director, Accounting Transformation will manage and support initiatives that will modernize, streamline, and enhance processes impacting the Accounting and Finance teams. This new role is ideal for a motivated individual who thrives on working on meaningful projects while bringing stakeholders along through all facets of the journey. Key Duties and Responsibilities: Manage daily aspects of various transformation projects while keeping deliverables on track to meet agreed upon timelines. Drive analysis of large data sets and provide clear interpretations as a result. Engage with appropriate stakeholders to ensure reporting impacts are well understood, documented and addressed effectively. Collaborate with cross-functional teams to analyze and document current and future state process workflows Develop and execute strategy for testing system implementation and process updates, with a focus on transactional testing through reporting in a SOX compliant manner. Partner closely with DTE, Accounting, Finance and other stakeholders, including any 3rd party vendors on gathering and finalizing requirements and cross functional resources needed Implement best practices in financial reporting, internal controls, and compliance to ensure accuracy and consistency of accounting records Assist with change management efforts to ensure the successful adoption of new systems, tools, and/or processes Effectively communicate with and train stakeholders on any new tools or processes as needed Knowledge and Skills: Demonstrated transformation experience with complex integrated transactional and reporting systems. Oracle EBS and Hyperion Essbase knowledge strongly preferred. Understanding of accounting transactional system workflows and accounting principles. Solid understanding of data movement into various reporting layers and hierarchies Reporting enhancements including requirements gathering and functional design documents. Possesses solid interpersonal and organizational skills with an understanding of Lean principles and project management terminology. Able to anticipate change and leading by example with a “can do” attitude. Excellent written and verbal communication skills including the ability to succinctly convey relevant information across multiple levels of the organization. Strong understanding of internal controls and compliance requirements. Knowledge of Tax and Treasury terminology a significant plus Education and Experience: Bachelor's degree in either Accounting, Finance, Information Technology, Business or a related field Typically requires 10+ years of experience in finance or accounting with a large, complex, multinational organization Project experience leading and/or supporting transformational initiatives Experience with transactional system design and testing Life science industry experience is preferred A track record of success working in a team-based environment Experience with SmartView, RPA BOTS, and latest AI advancements is preferred #LI-HYBRID Pay Range: $144,000 - $216,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com