Otsuka Pharmaceutical Co., Ltd.

The Hospital Specialist will conduct proactive outreach to healthcare professionals, facilitating discussions and elevating insights to inform strategic decisions. This role involves engaging customers through various tools and organizing local provider groups for discussions on patient care experiences and outcomes. | Candidates must have a minimum of 2 years of pharmaceutical or medical device sales experience and reside within a commutable distance of 50 miles from Eugene, OR. A proven track record in coaching and mentoring, along with the ability to communicate complex clinical information, is essential. | Otsuka America Pharmaceutical Inc. is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In its evolved customer engagement model, a Hospital Specialist engages healthcare providers (HCPs) using in-person, virtual, and digital tools, offering expertise on products and their approved conditions. This model enhances patient, caregiver, and HCP experiences by focusing on local care delivery, aiming to improve patient care and provide a superior experience. The "ecosystem approach" unifies account management, medical, patient access, and market access teams to engage with local healthcare systems, identifying opportunities to enhance the patient experience. This matrix model ensures coordinated and seamless care, supported by digital tools to bridge care gaps. These ecosystems are led by Area Business Leads and are organized into regional areas. Area Business Leads have significant autonomy to assess unique market priorities and tailor decisions to meet local customer needs. In the future, Otsuka aims to enhance customer engagement quality, accountability, and cohesion between patients and healthcare providers, with a focus on customer-centricity. The Hospital Specialist will report directly to the respective Area Business Lead, coordinating with cross-functional colleagues in Medical, Market Access, and Patient Support under appropriate guidelines. This individual will serve as the primary point of contact for HCP customers and should possess a broad range of expertise, capable of addressing complex on-label information based on approved content. Purpose This position is designed to enhance customer engagement, thought leadership, and business planning within the organization. The role involves proactive outreach to healthcare professionals (HCPs), facilitating discussions, and elevating insights to inform strategic decisions. Below is a detailed overview of the key responsibilities and objectives associated with this position: Key Responsibilities Conduct proactive outreach to HCPs on topics such as product access, on-label information, and established patient care guidance. Engage customers through various virtual or digital tools and direct them to other colleagues (e.g., MSLs) as needed. Facilitate speaker programs and organize local provider groups for discussions on experiences and outcomes with local/regional leaders. Elevate opportunities and feedback to the Area Business Lead, including local market insights to inform local strategy and business goals. Experience & Qualifications A minimum of 2 years of pharmaceutical or medical device sales experience. Must reside within a commutable distance of 50 miles from the primary city in the sales territory. Previous cross-functional industry experience in commercial life sciences or related industry. 4 or more years of experience working in a sales role with HCPs, ideally representing multiple products. Ability to work in an ambiguous environment undergoing transformation. Proven track record in coaching, training, and mentoring peers or others. Demonstrates a commitment to ethical business practices, an understanding of regulatory standards, and the ability to execute business activities in compliance with Company policies and guidance. Ability to assimilate and communicate complex clinical and product information Key Sales Capabilities Territory Analysis / Business Planning Uses competitive data and business reports to track progress and uncover opportunities, including sales data and promotional budget Displays knowledge of territory and business conditions that impact sales results to establish near term priorities for his/her territory business plan Responds compliantly to competitive threats and opportunities Educates office staff on payer guidelines and reimbursement procedures to increase pull through Effectively utilizes promotional materials Selling Skills, Engagement & Account Pull Through Maintains ongoing awareness of internal support team resources available throughout the ecosystem and utilizes appropriately Applies market and industry knowledge to overcome objections and influence prescribing habits during the total office call Identifies territory professional groups to network and ensure access/exposure to potential key opinion leaders Builds strong relationships with all key office/practice personnel and focuses on patient health in conversations with all staff members. Takes personal responsibility for follow-through and providing value to the accounts by providing accurate information in response to their needs Delivers effective and balanced office calls and sales presentations utilizing the appropriate approved marketing materials and technical references (e.g. studies, package inserts, etc.) with clarity and confidence to help HCPs enhance patient outcomes; demonstrates competent product knowledge of own product and competition #LI-REMOTE 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 $112,800.00 - Maximum $162,150.00, 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; https://www.otsuka-us.com/careers-join-otsuka. 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. 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 https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. 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: 800-363-5670. 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: https://www.ic3.gov, or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.

The Associate Director will develop and lead the omnichannel strategy for Global Medical Affairs across all therapeutic areas and brands. They will act as the primary business partner between Medical Affairs and the Omnichannel Center of Excellence, ensuring optimized engagement strategies for healthcare professionals. | Candidates should have a B.A. or B.Sc. and 3-5 years of experience in omnichannel strategy and digital engagement. Preferred qualifications include an MBA and experience in Medical Affairs within the pharmaceutical or healthcare industry. | Position Summary: The Associate Director of Global Medical Affairs Omnichannel will be responsible for developing and leading the omnichannel strategy for Global Medical Affairs across all therapeutic areas and brands. This strategic leader will serve as the primary business partner between Medical Affairs and the Otsuka Omnichannel Center of Excellence (CoE) and broader technology teams, ensuring medical content and engagement strategies are optimized, personalized, and aligned with the needs of healthcare professionals (HCPs) and other stakeholders. The ideal candidate is a forward-thinking, collaborative leader with deep experience in the ever-developing Omnichannel effort in the pharmaceutical industry with a focus on Medical Affairs initiatives. Key Responsibilities: Omnichannel Strategy & Execution: Design, implement, and optimize the Medical Affairs omnichannel engagement strategy across all brands. Partner with cross-functional teams to ensure seamless integration of scientific content and engagement channels, including email, web, mobile, Field Medical Affairs, and other digital platforms. Critical partner with the Medical Strategy teams to drive GMA Omnichannel efforts cross-functionally, acting as the GMA Omnichannel point. Monitor and evaluate omnichannel performance metrics and drive continuous improvement in reach, engagement, and scientific impact. Cross-functional Collaboration: Serve as the key liaison between Global Medical Affairs, Omnichannel CoE, IT/Technology, and Data & Analytics teams. Ensure Global Medical Affairs’ needs and priorities are represented in enterprise-wide initiatives. Lead the development of requirements for technology platforms that enable tailored, compliant medical engagement. Medical Content Integration: Oversee the adaptation and deployment of scientific content across multiple channels, ensuring alignment with customer journeys and preferred formats. Help guide internal teams on content modularization, tagging, and personalization strategies to optimize HCP engagement. Compliance & Governance: Ensure all omnichannel activities adhere to internal medical, legal, and regulatory standards. Collaborate with Compliance and Legal to maintain robust review processes and documentation. Leadership & Innovation: Provide strategic guidance and thought leadership on emerging trends in medical omnichannel engagement. Influence digital upskilling across the Global Medical Affairs team to enhance understanding and adoption of omnichannel capabilities. Customer Experience Design: Lead the development and implementation of customer experience design and omnichannel expertise tailored for global medical affairs. Develop and execute customer-centric integrated experiences with personal and non-personal touchpoints, focusing on critical moments aligned with brand and indication strategic imperatives, customer journeys, and messaging strategy. GMA Training & Support: Drive the adoption of omnichannel methods and provide training and support to enhance customer engagement through analytics and technology across GMA. Core contributor working with internal GMA training teams while aligning with CoE training efforts. Performance & Risk Management: Provide regular updates on the performance and effectiveness of omnichannel methods, proposing enhancements as needed. Identify and escalate potential execution risks and their impact on stakeholders. Process Improvement: Navigate and resolve ambiguity by identifying and addressing hidden process gaps that impact project progress and efficiency. Learning & Development: Bring an inquisitive and learning-oriented mindset to all interactions, asking thoughtful questions to deepen understanding and build a well-rounded knowledge base. Autonomy & Confidence: Demonstrate comfort and confidence working autonomously, especially in situations where expectations may be ambiguous or not clearly defined. Travel & Collaboration: Although this is a remote role, 30% travel for in-person meetings will be essential, including travelling to Otsuka Princeton/Rockville offices as needed. Minimum Qualifications: B.A. or B.Sc. 3-5 years of experience in omnichannel strategy and/or digital engagement. Medical material and tactical development experience. Customer Journey Mapping experience. Preferred Knowledge, Skills, and Abilities: MBA or other advanced degree, preferred. Track record of successfully launching and scaling medical omnichannel initiatives. Experience in Medical Affairs and/or Field Medical experience within the pharmaceutical, biotech, or healthcare industry, preferred. Deep understanding and technical platform knowledge to execute a seamless customer experience. Experience applying AI and/or Machine Learning models. Experience working within a matrixed environment. Knowledge of pharmaceutical legal, regulatory, and medical processes. Strong matrix team-building skills, a team-oriented approach, and supportive management style. Solid written and oral communication skills as well as good presentation skills. Ability to develop consistent, well-supported, competitive strategies. Proven leadership, strategic, and analytical abilities. Proven ability to manage multiple priorities in a fast-paced environment. Experience with modular content platforms, CRM systems (e.g., Veeva), and digital analytics tools. 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; https://www.otsuka-us.com/careers-join-otsuka. 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. 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 https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. 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: 800-363-5670. 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: https://www.ic3.gov, or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.

The Neuroscience Specialist will engage healthcare providers using various tools to enhance customer engagement and facilitate discussions. This role involves proactive outreach and collaboration with cross-functional teams to inform strategic decisions. | Candidates must have a minimum of 2 years of pharmaceutical or medical device sales experience and reside within 50 miles of the primary city in the sales territory. A proven track record in coaching and the ability to communicate complex clinical information is essential. | Job Summary Otsuka America Pharmaceutical Inc. is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In its evolved customer engagement model, a Neuroscience Specialist engages healthcare providers (HCPs) using in-person, virtual, and digital tools, offering expertise on products and their approved conditions. This model enhances patient, caregiver, and HCP experiences by focusing on local care delivery, aiming to improve patient care and provide a superior experience. The Neuroscience Specialist will report directly to the respective Area Business Lead, coordinating with cross-functional colleagues in Medical (MSLs), Market Access (HSAMs), and Patient Support (PELs) under appropriate guidelines. This individual will serve as the primary point of contact for HCP customers and should possess a broad range of expertise, capable of addressing complex on-label information based on approved content. Position Overview This position is designed to enhance customer engagement, thought leadership, and business planning within the organization. The role involves proactive outreach to healthcare professionals (HCPs), facilitating discussions, and elevating insights to inform strategic decisions. Below is a detailed overview of the key responsibilities and objectives associated with this position: Personally engage customers through various virtual or digital tools. Direct customers to other colleagues, such as Customer Service Specialists (CSS), as needed. Ensure customer requests are met and solicit feedback on the quality of engagement. Facilitate speaker programs to share knowledge and insights. Organize local provider groups for discussions on experiences and outcomes with local/regional leaders. Elevate opportunities and feedback to the Area Business Lead, including local market insights. Collaborate compliantly with the ecosystem team to adjust targeting and call point plans. Action on insights collected from customer-facing roles to inform local strategy and business goals. Key Responsibilities Conduct proactive outreach to HCPs on topics such as product access, on-label information, and established patient care guidance. Engage customers through various virtual or digital tools and direct them to other colleagues (e.g., CSS) as needed. Facilitate speaker programs and organize local provider groups for discussions on experiences and outcomes with local/regional leaders. Elevate opportunities and feedback to the Area Business Lead, including local market insights to inform local strategy and business goals. Experience & Qualifications A minimum of 2 years of pharmaceutical or medical device sales experience. Must reside within a commutable distance of 50 miles from the primary city in the sales territory. Previous cross-functional industry experience in commercial life sciences or related industry. 4 or more years of experience working in a sales role with HCPs, ideally representing multiple products. Ability to work in an ambiguous environment undergoing transformation. Proven track record in coaching, training, and mentoring peers or others. Demonstrates a commitment to ethical business practices, an understanding of regulatory standards, and the ability to execute business activities in compliance with Company policies and guidance. Ability to assimilate and communicate complex clinical and product information. Key Sales Capabilities Territory Analysis / Business Planning Uses competitive data and business reports to track progress and uncover opportunities, including sales data and promotional budget Displays knowledge of territory and business conditions that impact sales results to establish near term priorities for his/her territory business plan Responds compliantly to competitive threats and opportunities Educates office staff on payer guidelines and reimbursement procedures to increase pull through Effectively utilizes promotional materials Selling Skills, Engagement & Account Pull Through Maintains ongoing awareness of internal support team resources available throughout the ecosystem and utilizes appropriately Applies market and industry knowledge to overcome objections and influence prescribing habits during the total office call Identifies territory professional groups to network and ensure access/exposure to potential key opinion leaders Builds strong relationships with all key office/practice personnel and focuses on patient health in conversations with all staff members. Takes personal responsibility for follow-through and providing value to the accounts by providing accurate information in response to their needs Delivers effective and balanced office calls and sales presentations utilizing the appropriate approved marketing materials and technical references (e.g. studies, package inserts, etc.) with clarity and confidence to help HCPs enhance patient outcomes; demonstrates competent product knowledge of own product and competition #LI-Remote Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Minimum $104,400.00 - Maximum $162,150.00, 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; https://www.otsuka-us.com/careers-join-otsuka. 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. 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 https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. 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: 800-363-5670. 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: https://www.ic3.gov, or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.

The Associate Director will lead the logistical management of the integrated communication & evidence planning process, ensuring comprehensive evidence packages are available to support regulatory and launch strategies. This role involves collaboration with cross-functional teams to manage project plans and operational activities for developing and maintaining ICEPs. | Candidates should have a Bachelor's degree in life sciences and at least 5 years of experience in the pharmaceutical or digital health sectors. A solid understanding of evidence requirements and drug development lifecycle is essential, along with strong project management and communication skills. | Summary: The Global Integrated Evidence Operations, Associate Director role primarily focuses on leading and logistical management of integrated communication & evidence planning (ICEP) process steps, which includes managing end-to-end project plans and operational activities for developing/maintaining ICEPs in our digital planning solution. The Global Integrated Evidence Operations, Associate Director works closely with Global Integrated Evidence Strategy lead and collaborates with cross-functional teams to manage the creation and refresh cycles of ICEPs for prioritized assets and programs, ensuring comprehensive evidence packages are available to support regulatory, launch, and post-launch strategies. In addition, the role will be critical in facilitating evidence planning and generation governance at both the leadership and team level to ensure plans are aligned with the asset vision and individual studies align with strategic objectives of ICEPs. This position reports to the Senior Director, Global Integrated Evidence & Innovation Operations and can be based in Princeton, New Jersey. Otsuka maintains a hybrid work policy and remote options will be considered for US candidates. Responsibilities: Support the creation and management of individual ICEPs with a focus on operational efficiency by building out and maintaining digital planning platform/repository: Gathering and organizing materials Conducting meetings and workshops with cross-functional teams Developing pre-reads and meeting content Recording notes and integrating feedback into final outputs Post outputs to the digital ICEP planning platform/repository and monitor progress of approved tactics. Track and report updates to the Global Integrated Evidence Strategy lead for timely reviews and refresh cycles. Identify connections between new or existing studies and ICEPs using digital planning platform/repository. Ensure operational excellence through the continued development and implementation of standardized processes, tools, and governance for ICEPs. Contribute to the development of operational KPIs and dashboards to monitor performance and drive continuous improvement for ICEPs. Facilitate evidence planning governance to ensure alignment with asset vision and strategic objectives. Facilitate evidence generation governance to oversee the execution of evidence generation activities. Contribute strategic thinking and thought partnership in planning and discussions for both ICEP and governance. Manage logistics for ICEP and governance processes, including scheduling meetings, preparing content, and synthesizing feedback. Recommend process improvements and efficiencies to Global Integrated Evidence team. Develop and maintain relationships with colleagues involved in the ICEP and governance processes. Requirements: Bachelor's degree in life sciences. At least 5 years of experience in pharmaceutical and/or evidence generation and/or digital health in life sciences / technology sector. Competence in drug development lifecycle and scientific understanding of assets. Demonstrated solid understanding of evidence requirements in US and globally, key concepts and principles related to Ph1-4 clinical studies and non-interventional studies including an understanding of strengths and limitations of a methodological approaches and clinical trial designs. Possess an enterprise mindset and experience establishing strong collaborative internal relationships in a matrixed organization with global and local colleagues. Ability to gain senior leadership alignment on functional area initiatives and programs. Excellence in strategic thinking and problem solving. Demonstrated skills working in complex corporate environments and exercising influence without authority. Ability to create an environment with high energy, enthusiasm, and motivation. Ability to thrive under pressure, meet deadlines, and lead parallel projects. Strong scientific writing skills and interpersonal written/verbal communication skills. Capability to synthesize large amounts of data into meaningful content. Excellent project, time management, and organizational skills. Preferred: Formal training or certification in project management methodologies (PMP, Six Sigma, Agile). Experience in developing IEPs or managing complex processes across cross-functional stakeholders. Experience in leading or working closely with leadership governance. Successful execution and management of multiple projects supporting life sciences research. Technical experience in drug development/commercialization. Knowledge of drug development lifecycle functions such as Discovery, Clinical Trials, and Regulatory. Experience with digital technology to support management of planning and research. 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; https://www.otsuka-us.com/careers-join-otsuka. 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. 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 https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. 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: 800-363-5670. 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: https://www.ic3.gov, or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.

Develop and execute territory-specific business plans, engage healthcare providers and stakeholders, collaborate cross-functionally to increase disease-state awareness and patient acquisition, and meet sales goals in a rare disease space. | Bachelor’s degree, 3+ years sales experience in rare disease or related fields preferred, proven track record meeting sales targets, strong strategic thinking, collaboration, and communication skills, and ability to navigate complex healthcare environments. | Job Summary Otsuka America Pharmaceutical, Inc. believes in a customer engagement approach designed to better deliver on patient, caregiver and HCP expectations in the treatment of rare diseases. This model is built around where patients get their care—locally, with the intent to better serve patients, caregivers, and healthcare providers, delivering a higher quality experience that ultimately is focused on improving patient care. Otsuka’s Rare Disease Selling Model creates a unified focus among account management, medical, patient access, market access and total office education to engage physicians and identify opportunities to improve the patient experience. Through this matrix model, customers will experience coordinated and seamless support to provide the extraordinary care to the patients they serve. The Rare Disease Account Manager will report directly to the Area Business Lead, Rare Disease, coordinating with cross functional colleagues in Medical (MSLs), Market Access (RAMs), and Patient Support (PELs), Though Leader Liaison (TLL) under appropriate guardrails. This individual will serve as the main point of contact/connection to healthcare provider (HCP) customers and accounts and should have a wide breadth of expertise, (e.g. able to address complex on label information based on approved content in a competitive landscape. Purpose The Rare Disease Account Manager will work collaboratively with cross functional peers to develop a dynamic business plan and execution strategy for engaging with key systems of care to create joint value for Otsuka, customers, and patients. Key Responsibilities The Rare Disease Account Manager will work with the Area Business Lead, Rare Disease to develop a territory-specific business/account plan to include strategies and tactics aimed at increasing disease-state awareness, implementing diagnostic approaches, identifying and pursuing business opportunities and meeting sales goals in a rare disease space. Communicates and collaborates within a cross functional team (i.e. other RDAMs, brand marketing, market access, medical affairs and thought leader liaisons) necessary to meet business objectives. Develops in-depth knowledge of current and future competition and executes sales strategies to effectively compete and achieve patient acquisition and revenue goals. The RDAM will build and maintain proficiency in relevant disease states, patient and clinic experience, market landscape and product knowledge. Effectively utilize all available tools, technology and resources to analyze and identify market opportunities trends. Proven ability to navigate and identify opportunities through dynamic healthcare landscape including academic institutions, IDNs, community practices, and local patient advocacy groups Ability to successfully execute upon a rare disease selling model. Sponsor and display at relevant congresses and society meetings. Demonstrated expertise with longer selling cycle and complex patient journey across portfolio of products. Experience & Qualifications Bachelor’s degree required; MBA or other related graduate degree preferred 3 years or more sales experience in rare disease, immunology, renal, oncology, and/or hospital account manager is strongly preferred Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals in a fast-paced dynamic sales environment Candidate must display intellectual curiosity, business acumen, perseverance, relationship mastery, collaboration, passion for the patient Ability to interpret, analyze and leverage data to identify trends, gain insights, drive pull through, and lead live engagements with customers in the local business environment Demonstrates strategic thinking to create a customer/account engagement plan, taking a dynamic and collaborative approach to maximize the business Exhibits intellectual curiosity and maintains ongoing awareness of trends in his/her area of expertise and leverages knowledge and insights to positively impact the business Respectfully collaborates to cultivate partnerships with a variety of internal and external stakeholders and incorporates these diverse views into decision making process within a complex and competitive healthcare environment (e.g., payers, health systems, matrix partners) Apply expert knowledge of the marketplace, applicable competitors, industry, and matrix functional activities/plans to anticipate and optimally manage business opportunities and challenges in an ambiguous environment Demonstrates a commitment to ethical business practices, an understanding of regulatory standards, and the ability to execute business activities in compliance with Company policies and guidance. Facilitates clinical dialogue that compels the customer to act on behalf of their patients and engage the entire account to understand any obstacles that exist to provide appropriate solutions to ensure customer needs are met Develop and position Otsuka as a leader with key Nephrology stakeholders and other specialty customers and targeted accounts (large group practices and community practices) Key Sales Capabilities Territory Analysis / Business Planning Uses competitive data and business reports to track progress and uncover opportunities, including sales data and promotional budget Displays knowledge of territory and business conditions that impact sales results to establish near term priorities for his/her territory business plan Responds compliantly to competitive threats and opportunities Educates office staff on payer guidelines and reimbursement procedures to increase pull through Effectively utilizes promotional materials Selling Skills, Engagement & Account Pull Through Maintains ongoing awareness of internal support team resources available throughout the ecosystem and utilizes appropriately Applies market and industry knowledge to overcome objections and influence prescribing habits during the total office call Identifies territory professional groups to network and ensure access/exposure to potential key opinion leaders Builds strong relationships with all key office/practice personnel and focuses on patient health in conversations with all staff members. Takes personal responsibility for follow-through and providing value to the accounts by providing accurate information in response to their needs Delivers effective and balanced office calls and sales presentations utilizing the appropriate approved marketing materials and technical references (e.g. studies, package inserts, etc.) with clarity and confidence to help HCPs enhance patient outcomes; demonstrates competent product knowledge of own product and competition #LI-Remote 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. Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka. 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. 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 https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. 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: 800-363-5670. 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: https://www.ic3.gov, or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.

The Senior Manager, Global Regulatory Affairs provides critical support in developing global regulatory strategy and manages lifecycle activities for assigned projects. They work collaboratively with the global regulatory team to address regulatory issues and execute submissions to regulatory authorities. | Candidates should have a Bachelor's degree with 5+ years of experience or a Master's degree with 2 years of experience in regulatory affairs or related areas. Experience with FDA or other health authority interactions is desirable. | Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. Job Responsibilities - Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products. - Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines. - Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines. - Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities. - Serves as the sponsor point of contact to the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues. - Effectively manages and directs internal support staff and external consultants for assigned projects. - Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions. - Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output. - Assess and develop innovative ideas to move GRA department to address current and future challenges. Knowledge, Skills, and Competencies Knowledge - Experience working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. Skills - Strong oral and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. - Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed. - Able to establish close communications and working relationship with cross functional teams to meet business objectives. Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow. - Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). Competencies See OPDC Competencies Chart (Level X) Physical Demands and Work Environment Travel (approximately 20%) See document Physical Demands and Work environment for further requirements. Education and Related Experience Bachelor's degree with 5+ years’ experience or Master’s degree with 2 years’ experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. 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 $210,100.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws. 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; https://www.otsuka-us.com/careers-join-otsuka. 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. 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 https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. 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: 800-363-5670. 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: https://www.ic3.gov, or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.