Executive Director jobs at PharMerica - 27 jobs

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

The Executive Director, Global Value Evidence Lead, is a strategic leader responsible for driving the global value evidence strategy across the company's portfolio. This senior leader will provide strategic vision and leadership for value evidence activities at Otsuka, ensuring robust, innovative, and fit-for-purpose evidence is generated to support product differentiation, market access, and reimbursement across geographies. The incumbent will lead a team of value evidence asset leads and collaborate with internal and external stakeholders to shape the value narrative and evidence plans from early development through post-launch. **Key Responsibilities:** + Oversee the Global Value Evidence (GVE) strategic planning and execution processes to ensure alignment with asset and company business priorities + Lead team of value evidence TA and assets leads who design and implement HEOR, RWE, and other evidence generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate the differentiated value of our products + Utilize advanced scientific knowledge and emerging trends to drive innovation in value evidence + Provide mentorship, support in career development and performance management for direct reports + Enhance the department's capabilities by developing skills, nurturing a culture of scientific excellence, and ensuring strategic impact + Support in proactively identifying and solving complex problems that impact the management and direction of the GVE department + Cultivate strong, collaborative relationships with key internal stakeholders and communicate matters of significant importance to the department, broader function and organization + Represent the company in external engagements with HTA bodies, payers, academic institutions, and industry consortia. + Ensure compliance with global regulatory and ethical standards in evidence generation and data use. **Qualifications:** + Advanced degree (PhD, PharmD, MD, MPH, or equivalent) in a relevant scientific or health-related field. + 10+ years of experience in pharmaceutical, biotech, or healthcare consulting, with a strong focus on HEOR, RWE, and market access strategy. + Demonstrated leadership in developing and executing global evidence strategies for successful product launches and access. + Recognized within the outside scientific community as a thought leader in value evidence through publication in peer reviewed journals, presentations, involvement in scientific/professional associations etc. + Deep understanding of global HTA and payer requirements, regulatory frameworks, and healthcare systems. + Deep understanding of industry best practices + Exceptional strategic thinking, communication, and stakeholder engagement skills. + Proven ability to lead cross-functional teams and influence senior leadership. **Preferred Qualifications:** + Experience in multiple therapeutic areas, including specialty or rare diseases. + Familiarity with innovative evidence platforms, digital health technologies, and advanced analytics. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

How to Maximize your opportunity to do rewarding work, your future leadership potential, and your career growth? Join an industry leader. [Become one, too!] Want to be a part of something exciting? At Octapharma Plasma you can channel your passion for helping others into a medical career that is fast-paced and personally and professionally rewarding. We own and operate plasma collection centers throughout the United States. Our services are critical to the development of life-saving patient therapies utilized by thousands of patients all over the world. Octapharma Plasma is a subsidiary of one of the world's largest plasma products manufacturers, Octapharma AG, a Switzerland-based company that has been committed to patient care and medical innovation for 40 years. Octapharma employs over 5,000 people and has biopharmaceutical experience in 70 countries worldwide. The pay range for this position at commencement of employment is expected to be between $65,300 and $108,800 per year; however, unexpected and necessary adjustments or increases may result from Company annual salary increases, if applicable, and or fluctuations in the job market necessitating adjustments to pay ranges. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus and in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and paid time off benefits, including parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. ASSOCIATE CENTER DIRECTOR This Is What You'll Do: Maintains all donor center functions and assets. Maintains a thorough understanding of and ensures total operation is compliant with state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance. Shapes employment decisions to include hiring, promotions, demotions, and terminations that strategically align with both employee and business needs. Oversees and administers center level employee training ensuring alignment with compliance standards, while overseeing their execution and timeliness. Supervises the implementation of training procedures, including the induction of new processes and the annual retraining initiatives. Manages and oversees Payroll records to optimize the efficient allocation of employee hours. Strategically analyze and manage operational Key Performance Indicators (KPIs) while proactively addressing operational deficiencies. Optimize operational cost to meeting and exceeding targeted objectives Ensures that product shipments and sample submissions are accurate and performed in accordance with shipping schedules. Oversee marketing and advertising initiatives, collaborating with relevant corporate departments to pinpoint and implement essential enhancements. Maintains a professional and courteous relationship with donors that will stimulate donor retention, referrals, and production growth. Creates an organizational environment that stimulates the morale and productivity of the work force and its leadership. This Is Who You Are: A natural leader that nurtures a robust and positive culture within the donor center, exemplifying company core values. Outgoing, personable, energetic, and enthusiastic. Excited to teach, learn, and advance with a growing organization. Self-motivated and willing to assume the initiative. Attentive, Organized, Multi-tasking, Problem solver. This Is What It Takes: Bachelor's degree or up to 3 years of related experience preferred. Up to 3 years of operations and/or process management/supervisory experience preferred. 3 years of people management preferred (can be concurrent with operations/management experience), including recruiting and training. Experience with responsibility for fiscal management and/or budgeting preferred. Experience working in a highly regulated industry preferred. Effective communication and organizational skills required. Excellent written, verbal, and interpersonal communication skills required. Experience with office software preferred. Ability to work daytime and evening hours, weekends, holidays, extended shifts and periodically after hours. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Tuition Reimbursement Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: octapharmaplasma.com INNER SATISFACTION. OUTSTANDING IMPACT.

The Associate Director, Rare Disease Strategic Planning Lead will support the assets of varying lifecycle stages in the Rare Disease portfolio. This role is crucial in driving operational excellence and innovation within our Global Medical Affairs organization, with a specific focus on Rare Disease 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 Rare Disease 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 Rare Disease portfolio + Drive long-term planning for the Rare Disease 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 + Foster a culture of continuous improvement of fiscal stewardship within the global team + Serve as a strategic thought partner who confidently challenges investment decisions, ensuring alignment with broader organizational strategy and long-term value creation + Ensure cost-effective utilization of resources while maintaining high-quality outputs across all regions **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 + Rare disease experience required and relevant therapeutic area knowledge is preferred **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 $169,222.00 - Maximum $253,000.00, 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.

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.

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.

**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 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 $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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, 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.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Associate Director, Access and Reimbursement (AD ARM) will lead the Eisai Access and Reimbursement Managers (ARMs), Eisai's field-based access and reimbursement team within Market Access, supporting our Neurology and Oncology business units. The position will possess a deep and broad understanding of reimbursement and access trends across our healthcare landscape, as well as cross-functional business knowledge to drive Eisai's mission to create optimal access for patients and drive our human health care mission. This individual will provide appropriate support for patient access to prescribed Eisai products, which will include communication with healthcare professionals (HCPs) about insurance coverage, and coding and reimbursement for Eisai products and Eisai's patient support programs. This position will work collaboratively with appropriate Eisai stakeholders regarding access and reimbursement issues, including Payer Markets, Market Access and Reimbursement Services, Sales, Marketing, Government Affairs, Legal, Compliance, Medical, and Training. Ultimately, this individual will be responsible for delivering superior expertise and operational excellence in the Neurology and Oncology disease areas related to field reimbursement services. Working closely with and reporting to the Director, Access and Reimbursement, the AD ARM will be responsible for the leadership, direction, and management of a team of ARMs; the AD ARM will be functional lead for ARM activities across HCP offices, institutions, and Medicare Administrative Contractors (MACs). As such, the position plays a key role in developing and driving compliant execution of access and reimbursement programs. In addition to these leadership responsibilities, the AD ARM is also responsible for maintaining appropriate relationships with accounts, as needed, to ensure appropriate access and reimbursement for Eisai's portfolio. Due to the AD ARM's leadership and access expertise, this role is viewed by colleagues and customers as a central resource of knowledge and information about patient access and reimbursement to prescribed Eisai medications. Key External Stakeholders: Health Care Professionals and stakeholders responsible for physician reimbursement and patient coverage and access issues. These stakeholders include, but are not limited to, the following: Practice Mangers, Financial Counselors, Pharmacy Managers/Directors, Business Administrators, State Societies, and DME/MAC personnel. The states included in this geography are PA, MD, DE, VA, WV, KY, OH, IN, TN.Responsibilities: * Lead field access and reimbursement team in providing appropriate support for patient access for prescribed Eisai products. * Direct and oversee HCP communication on insurance coverage/reimbursement for Eisai products and relevant patient support programs. * Collaborate with cross-functional teams to drive resolution of access and reimbursement issues. * Develop and drive compliant execution of access and reimbursement programs. * Maintain appropriate relationships with accounts, as needed, to ensure appropriate access and reimbursement for Eisai's portfolio. * Recruit, develop, train, coach, assess, motivate and retain access and reimbursement talent to support appropriate access and reimbursement. Qualifications: * Bachelor's degree (Master's degree preferred) with 10+ years of relevant experience in pharma/biotech industry. * Experience in patient access or reimbursement experience, preferably with clinical understanding within relevant therapeutic area (including in-patient and out-patient care management). * Substantial experience in patient support programs, financial assistance, and patient assistance programs. * Market Access payer and/or patient access support programs experience. * Substantial experience of the US healthcare system across major payer segments (Medicare, Medicaid, Federal, and Commercial) * Substantial experience working with medical and pharmacy benefits, coverage policies, and reimbursement. * Experience monitoring the US healthcare payment system, including national and local challenges for strategic planning for portfolio of therapies. * Substantial experience of the various distribution systems within the US healthcare environment. * Project management experience driving complex initiatives in collaboration with key cross-functional stakeholders. * Experience mentoring and training team members on reimbursement activities and procedures. * Proven performance in earlier role. As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Industry & Regulatory (Market Access), Mentoring/ People Development, Project Management, Reimbursement Knowledge Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Access & Reimbursement - (Mid Atlantic) is from :$191,800-$251,800 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

How to Maximize your opportunity to do rewarding work, your future leadership potential, and your career growth? Join an industry leader. [Become one, too!] Want to be a part of something exciting? Help Octapharma Plasma open our next Donor Center! At Octapharma Plasma you can channel your passion for helping others into a medical career that is fast-paced and personally and professionally rewarding. Is your goal to utilize your leadership skills to achieve business goals and truly make a difference with your business results? At Octapharma Plasma, you can channel your passion for leading others into a healthcare management career that is fast-paced and personally and professionally rewarding. Our donor center is in need of a Donor Center Director who is strong at leading staff in achieving operational results and meeting quality goals. The selected candidate will thrive on working with a diverse workforce, engaging with our donors, and creating a team environment in the center. We offer a positive, upbeat work environment where all employees work together for the common good of others, and for the many individuals who benefit from our work. While healthcare experience is a plus, we are looking for someone who has a successful track record of delivering results through the leadership of employees and in collaborating with other departments. Effective communication skills are a must, as well as the ability to develop and maintain a team environment. Our team is dedicated to exceptional customer service, while building a successful partnership with the community in which we work. If this sounds appealing, then this job may be for you! DONOR CENTER DIRECTOR This Is What You'll Do: Oversees donor center staff and operations, including production, quality compliance, finance, HR, and IT. Acts as a liaison with all corporate functions to ensure center compliance and performance. Maintains a thorough understanding of state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance. Complies with federal, state, local and company-specific regulations related to quality of product, employee and donor safety and to the proper performance of day-to-day activities. Ensures that product shipments and sample submissions are accurate and performed in accordance with shipping schedules. Maintains a professional and courteous relationship with donors that will stimulate donor retention, referrals, and production growth. Ensures projected production budget is met in both quantity and potency. Trains, develops, and manages all staff in accordance with the Human Resources and company policies and other established management guidelines and regulations. Creates an organizational environment that stimulates the morale and productivity of the work force and its leadership. This Is Who You Are: A natural leader who displays strong character and integrity People person extending to a diverse group of individuals and demographics Outgoing, personable, energetic, and enthusiastic Excited to teach, learn, and advance with a growing organization Self-motivated and willing to assume the initiative Attentive, Organized, Multi-tasking, Problem solver Profession appearance and demeanor Strong communication, organizational, planning skills. Excellent written, verbal, and interpersonal communication skills. Demonstrated proficiency with Microsoft Office. Ability to work day and evening hours, weekends, holidays, and extended shifts. This Is What It Takes: Bachelor's degree preferred. Job experience will be considered in lieu of a degree. Minimum three (3) years' management/supervisory experience. Minimum three (3) years' experience recruiting, hiring, training and managing the performance of employees. Minimum one (1) year experience with responsibility for financial management and/or budgeting. Experience working in a highly regulated industry, preferred. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Tuition Reimbursement Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: octapharma.com INNER SATISFACTION. OUTSTANDING IMPACT.

How to Maximize your opportunity to do rewarding work, your future leadership potential, and your career growth? Join an industry leader. [Become one, too!] Want to be a part of something exciting? At Octapharma Plasma you can channel your passion for helping others into a medical career that is fast-paced and personally and professionally rewarding. We own and operate plasma collection centers throughout the United States. Our services are critical to the development of life-saving patient therapies utilized by thousands of patients all over the world. Octapharma Plasma is a subsidiary of one of the world's largest plasma products manufacturers, Octapharma AG, a Switzerland-based company that has been committed to patient care and medical innovation for 40 years. Octapharma employs over 5,000 people and has biopharmaceutical experience in 70 countries worldwide. The pay range for this position at commencement of employment is expected to be between $65,300 and $108,800 per year; however, unexpected and necessary adjustments or increases may result from Company annual salary increases, if applicable, and or fluctuations in the job market necessitating adjustments to pay ranges. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus and in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and paid time off benefits, including parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. ASSOCIATE CENTER DIRECTOR This Is What You'll Do: Maintains all donor center functions and assets. Maintains a thorough understanding of and ensures total operation is compliant with state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance. Shapes employment decisions to include hiring, promotions, demotions, and terminations that strategically align with both employee and business needs. Oversees and administers center level employee training ensuring alignment with compliance standards, while overseeing their execution and timeliness. Supervises the implementation of training procedures, including the induction of new processes and the annual retraining initiatives. Manages and oversees Payroll records to optimize the efficient allocation of employee hours. Strategically analyze and manage operational Key Performance Indicators (KPIs) while proactively addressing operational deficiencies. Optimize operational cost to meeting and exceeding targeted objectives Ensures that product shipments and sample submissions are accurate and performed in accordance with shipping schedules. Oversee marketing and advertising initiatives, collaborating with relevant corporate departments to pinpoint and implement essential enhancements. Maintains a professional and courteous relationship with donors that will stimulate donor retention, referrals, and production growth. Creates an organizational environment that stimulates the morale and productivity of the work force and its leadership. This Is Who You Are: A natural leader that nurtures a robust and positive culture within the donor center, exemplifying company core values. Outgoing, personable, energetic, and enthusiastic. Excited to teach, learn, and advance with a growing organization. Self-motivated and willing to assume the initiative. Attentive, Organized, Multi-tasking, Problem solver. This Is What It Takes: Bachelor's degree or up to 3 years of related experience preferred. Up to 3 years of operations and/or process management/supervisory experience preferred. 3 years of people management preferred (can be concurrent with operations/management experience), including recruiting and training. Experience with responsibility for fiscal management and/or budgeting preferred. Experience working in a highly regulated industry preferred. Effective communication and organizational skills required. Excellent written, verbal, and interpersonal communication skills required. Experience with office software preferred. Ability to work daytime and evening hours, weekends, holidays, extended shifts and periodically after hours. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Tuition Reimbursement Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: octapharmaplasma.com INNER SATISFACTION. OUTSTANDING IMPACT.

We are looking for an experienced Associate Director of Facilities, office-based from our Global Headquarters location in Cincinnati, OH. In addition to overall responsibility for our Global Headquarters Campus, this position will have responsibility for an assigned region of offices as well as countries where we do not currently have physical offices, but maintain operations in both North America and South America. This role is responsible for Facilities (Office Services, Administration, Property Management and Office Project Management) functions and line management of Facilities associates in their region. Responsibilities * Corporate Campus Oversight: * Responsible for overall appearance and management of our corporate campus, located at Madison Square in Cincinnati; * Supervise local service providers, provide input and planning for installations, ongoing maintenance and scope of services to be provided; * Works closely with other businesses at Madison Square in order to coordinate services, events, and other logistical items where Medpace and the wider development are concerned; * Partner with campus security team to ensure campus operations are safe and secure during all hours * Develop and communicate plans for construction and other development projects in relation to campus traffic, security, and programming; * Work with senior leadership on wider campus initiatives and employee engagement events to promote a healthy, collaborative workplace for all associates on our corporate campus. * Office Services: * Line management of Facilities associates and management who support overall office administration, finance and other support services; * Vendor sourcing, selection and management for Facilities related vendors; * Provides oversight and inspection of overall office conditions and creates action plans for correction/maintenance as necessary; * Responsible for management of Health & Safety initiatives, risk assessments, training and compliance. * Office Administration: * Work closely with finance, legal, HR and IT to manage overall office administration of services, vendors and processing tasks; * Maintain accurate records and trackers related to office leasing, vendor contracts and capital expenditures; * Support development of annual budgets and forecasts in partnership with Global Head of Facilities; * Responsible for reviewing and pre-approving expense reports and vendor invoices to ensure compliance with accounting and invoicing standards. Ensure that expenses approved are within approved budget limits as necessary; * Support Head of Security with local office security controls/projects as necessary (Access Controls, Cameras, Physical Controls); * Support Business Continuity program and incident response in partnership with company leadership. * Property Management: * Line Management of Maintenance Management and Indirect Management of Maintenance team, supports maintenance workload planning and project management of maintenance projects in partnership with Maintenance management; * Manage relationships with landlords, building managers and associated companies to ensure terms of our leases and agreements are upheld and are in compliance; * Ensure building management is providing a safe, secure and clean building for our associates and our visitors; * Support Global Head of Facilities with real estate activities such as working with local brokers, identifying property options, collecting and negotiating leasing terms and providing feedback on potential landlord interactions as part of the overall decision making process; * Ensure that end of lease activities are planned for and completed to lease expectations (examples: dilapidations, return of space, close out inspections). * Office Project Management: * Works with Global Head of Facilities on office design, layout and scope of work for office construction projects (new offices, remodels, modifications, etc.); * Create and manage Request for Proposals (RFP) process for all vendors related to office projects, works with IT and Global Head of Facilities on scope and services to be included, as well as preparing an overall RFP summary report to facilitate decision making and approvals; * Develop project budget for approval, manages tracker of budget to ensure projects are completed both to their approved budget and agreed timeline; * Responsible for full project management of office projects, including managing dates and execution of other group's assignments (Examples: IT and Security tasks) and to ensure quality of work meets company standards. Qualifications * Bachelor's degree and 7+ years of experience in facilities management (Senior Manager level or above); Experience at the Associate Director level or above is preferred; * Excellent Communication and Presentation skills; * Prior experience with Project Management; * Experience managing facilities/administrative services staff, including experience managing staff located in other countries; * Working knowledge of building mechanical systems such as Heating and Cooling, Plumbing and Electrical systems is preferred. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Medpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers / Project Managers to join our Clinical Trial Management Group across our US offices. Our therapeutic areas of focus include Oncology/Hematology, Cardiovascular, Renal, Gastrointestinal, Endocrine/Metabolic, Infectious Disease, Neuroscience, and more. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates. Responsibilities * Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations * Serve as primary Sponsor contact for operational project-specific issues and study deliverables * Maintain in depth knowledge of protocol, therapeutic area, and indication * Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided * Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable * Develop operational project plans * Manage risk assessment and execution * Manage study vendors where applicable * Manage site quality and monitoring deliverables Qualifications * Bachelor's degree in a health-related field; Advanced degree in a health-related field preferred * Experience in Phases 1-4; Phases 2-3 preferred * 5+ years as a project/clinical trial manager within a CRO; * Management of overall project timeline * Bid defense experience, preferred * Strong leadership skills Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Medpace is currently seeking an office or home based Director of Proposals to join our Clinical Operations team at our HQ in Cincinnati, OH. The Director will collaborate closely with our medical experts and senior functional managers to create the operational strategy for new business development opportunities. This will include direct management of the proposal team. Responsibilities * Mentor/Lead Proposal Writers in the preparation of compelling, strategic proposals, rebids, and exhibits, including rigorous quality control and timeline adherence; * Review RFPs, identify any capacity issues, and negotiate deadlines with Business Development Executives, as needed; * Participate in pre-RFP client meetings; * Partner with Business Development, Medical and Operational personnel to design effective proposals; * Contribute strategic operational content to proposals; * Review and revise proposal content as needed to ensure a clear, compelling strategy to execute the trial is articulated; * Participate in client discussions and requests for information following delivery of proposal; * Lead the enhancement of proposal development tools and processes; * Stay abreast of latest industry tactics and strategies regarding proposal development; and * May be responsible for other projects and responsibilities as assigned. Qualifications * Bachelor's degree minimum, advanced degree preferred. * Highly-proficient employee with strong leadership, writing and problem solving skills; * 5+ years of project management/clinical trial management experience in clinical research; CRO experience preferred; * Must possess superior time management, planning and organizational skills, written and verbal communication skills, and quality decision-making skills; * Advanced knowledge of drug development, clinical trial management and operational procedures, including GCP guidelines; and * Demonstrated ability to effectively interact face-to-face with Sponsors and represent company in outside settings. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.