Vice President jobs at Astellas Pharma

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** Member of cross-functional teams, the primary purpose of the Associate Director is to act independently as Lead Safety Statistician (LSS) / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for complex/novel work in an established area (safety/clinical/ observational studies, MA tactic, Biomarker & PK/PD Analyses or local project), This position may also act as Global Statistical Lead (GSTATL) for an early or back up asset or as a Methodology expert validating the execution of complex techniques. The position is expected to complete these tasks with minimal supervision from the GSTATL, LPS or the Primary Focus Statistics Lead (PFSL). Under the supervision of an experienced statistician, the position can act as global safety statistical lead for a late phase or novel asset or represent Astellas on statistical matters related to safety data, clinical data, Biomarkers, PK/PD, PROs, or methodology at meetings with regulatory authorities, key opinion leaders and HTAs. The position may also research innovative solutions and train other statisticians. **Essential Job Responsibilities:** Provides best in class safety data science and statistical support to the asset level for Astellas drug development programs. For assigned projects, provides all required safety statistical support and deliverables by supervising another statistician, or as a member of study team. + Ensures quality and consistency of key safety data science deliverables. + Accountable for the Asset Level Safety Assessment Plan (ALSAP). + For early or non complex asset, independently provides strategic safety statistical input to the asset teams (for example, CDP, CMP, go/no go approach, OCs ) including design of studies and analyses requiring advanced statistical methodologies. + Executes biomarker and PK/PD strategies, leads large/complex studies or supports marketed products for a safety purpose. + Contributes to regulatory and payer dossiers and publications - provides statistical interpretation of the results. + Presents summary data and analyses to key stakeholders in a compelling and clear manner + Ensures availability of safety-related data, biomarker, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs. + May participate in due diligence activities, reviews safety data and advises company + Is responsible to implement, explain and validate complex safety statistical methodology **Personal Development / Collaboration** + Recognizes and addresses issues which may impact the statistical integrity of the development program or for which novel statistical methodology may add value + Contributes to cross-functional or indication level improvement initiatives (i.e write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards - selection and qualification/audits of vendors) + Contributes to the recruitment, training, professional development and retention of statistical personnel. + is a member of external industry or professional organizations, developing relations with leading academic institutions, advising internally on innovative Statistical methods or checking their correct implementation. **Qualifications:** **Required** + PhD or M.S in Biostatistics, Statistics or related scientific field + 6+ years (9+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas + Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical and biomarker data + Knowledge and skills in SAS required, knowledge of R preferred. + In-depth familiarity with processes and procedures in data management and programming + Experience working in an international environment + Experience in safety data analysis and risk management activities (e.g., ALSAP, DSUR, RMP, signal detection) at the asset level. + Good knowledge of medical literature, clinical, regulatory and commercial landscape + Ability to understand, implement, and explain complex statistical methodology. **Salary Range:** $141,400 - $222,200 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Quantitative Sciences & Evidence Generation Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

#LI-Remote The Director, US Market Access Therapeutic Area Strategy is responsible for optimizing the market ac-cess strategy for launch and inline brands. This role is responsible for working across the US market access organization to craft a holistic product access strategy and ensure delivery of strategies for their respective product(s) that reflect the expertise across the different specialties within the US market access (i.e., Strategic Pricing & Contracting, Commercial Access Integration, Patient & Support Services, Finance). Additionally, this individual will ensure that these strategies are executed across the broader affected organization (i.e., the Product, Integrated Marketing, and Customer Engagement Organiza-tions). The overarching objective is to ensure that each of our products is positioned for optimal payer coverage, affordability for appropriate patients, and durable value for Novartis over time and as the product matures and/or extends into new indications. This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel. Job Description Key Responsibilities: Functioning as the key point of contact for US and Global product teams, participating in all relevant product meetings and ensuring that other Market Access functions are involved and present as appropriate Ensuring the US Innovative Medicines Leadership Team (IMLT) is well-informed of product opportunities and challenges at any given time Developing an integrated 3- to 5-year Market Access product plan, which includes integration of short- and long-term access strategies in an annual Brand Planning processes Engaging with the Integrating Marketing and Customer Engagement Organizations to ensure that we are working efficiently, and market access strategies are seamlessly executed upon Partnering with Market Access Acct Management and Pricing & Channel Strategy to ensure that annual forecasts are accurate and reflect the latest market events Socializing US market access product strategies as appropriate with US and Global Product Leads and Executive Leadership Partnering with brand and other Market Access teams to secure annual budgets and ensure tactical plans support the Market Access product strategies Working closely and engaging with Legal, Compliance, Brand and Marketing teams to ensure tactics are aligned and implemented in an expeditious and compliant manner Mastering the NVS Material Approval Process, including FUSE platform, compliance with pharma/FDA marketing policies, and vendor payment systems Oversee development of critical market research including development of qualitative and quantitative areas of study, and determining fundamental go-to-market principles to achieve optimal product commercialization Manage vendor RFP process and ensuring contracting compliance. Responsible for managing multiple budgets and deliverables, including organizing interim project read-outs to ensure cross-functional alignment and ensuring deliverables do not exceed allocated budget Managing expectations across the organizations regarding Market Access conditions for individual products Positioning the US Market Access Portfolio Strategy team as a destination for high-potential associates across the organization (always be recruiting and fostering top talent) Works within ethical and compliance policies, ensures a diverse and inclusive environment free from all forms of discrimination and harassment, adheres with Company policies, state and federal laws and regulations and ensures those around him/her do the same. Essential Requirements: Education: Bachelor's degree required; MBA, Healthy Policy or equivalent preferred Minimum of 7 years of pharmaceutical experience in Marketing/Sales, Market Access or Managed Care Finance Thorough understanding, knowledge of and experience with US healthcare dynamics and the drivers of pharmaceutical value Success in the areas of commercial pharmaceuticals and a track record of execution and results Ability to recognize complex relationships and market dynamics and to synthesize simplified, direct and effective communications Strong interpersonal, communication, influencing and analytical skills combined with an ability to successfully collaborate across a matrix organization Demonstrated ability to manage multiple projects with potential inter dependent findings and deadlines Engage a diverse group of people across product, marketing and customer experience Ability to implement programs that deliver improved business results in a timely manner combined with ability to adapt to changes within the internal and external environment Demonstrated ability to manage multiple projects with potential inter dependent findings and deadlines Engage a diverse group of people across product, marketing and customer experience Ability to implement programs that deliver improved business results in a timely manner combined with ability to adapt to changes within the internal and external environment Proficient in Microsoft Office, particularly PowerPoint and Excel Travel as required Novartis Compensation Summary: The salary for this position is expected to range between $194,600.00 and $361,400.00 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $194,600.00 - $361,400.00 Skills Desired Access And Reimbursement Strategy, Access And Reimbursement Strategy, Agility, Analytical Skill, Analytical Thinking, Cross-Functional Collaboration, Customer-Centric Mindset, Employee Development, Finance, Go-To-Market Strategy, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Influencing Skills, Innovation, Inspirational Leadership, Lcm Strategy, Market Access Strategy, Negotiation Skills, People Management, Pricing Strategy, Process Management, Product Launches, Public Affairs {+ 7 more}

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. Novartis has operated at the forefront of the managed care industry and is taking further steps to address both the near-term managed care and healthcare systems issues as well as the longer term sustainability of the US pricing and access model. The US pharmaceutical market is large, profitable and still growing. The US healthcare system continues to advance regulatory approaches that favor innovation, including accelerated reviews for break-through therapies. The pharmaceutical pricing and market access environment, however, is under increasing pressure which is causing reductions in ac-cess to medications for appropriate patients. The managed care environment in which Novartis is operating is competitive and getting harder. . Payers are more aggressively managing utilization, and the bargaining power of the Payers has dramatically improved with the aggressive and widespread consolidation of market power into fewer and fewer entities. Today over 80% of lives are managed by the top 4 payers. The price of access has risen substantially even over the last three years for our most important products. That trajectory of that trend is set to continue unless we evolve our operating model and staff it with the best talent we can attract to the company. This role will integrate and drive the broader Novartis organization to gain and sustain access. The Director, Account Management & Pricing Strategy, will serve as the strategic team lead for large National and Contracted Regional Accounts and key inline brands that represent between 10%-20% of the US IM Business or $2B-$4B in Gross Sales. This role will be responsible for account development, integrating deeper and broader with large payers to gather competitive intelligence and customer in-sights to better position NVS brands on payer formularies. The Director will develop account specific contracting strategies and lead the implementation of customer contract/pricing programs for assigned accounts. This position is responsible for creating business solutions that meet both external customer and NVS business needs by working cross-functionally with internal executive management while gain-ing customer insights and payer business knowledge to effectively drive customer satisfaction and maximize Novartis business. Additionally, this position will champion the development and cross-functional interaction for optimal US Novartis Innovative Medicines pricing, contracting portfolio and Franchise strategies for assigned in-line, launch and pipeline products. Job Description Your responsibilities will include, but are not limited to: Strategy Development to achieve US Innovative Medicines business goals Collaborates with other National Account, Pricing, and Portfolio Strategy Develops account specific and portfolio contract strategies in line with Business Unit sales goals and customer needs; aligns Account strategy with other key Sales, Marketing, Medical and Managed Care functions and ensures cross-functional support Drive strategic account development integrating deeper and broader with large payers to gather competitive intelligence and customer insights to better position NVS brands on payer formularies and lead contract negotiations with key assigned Accounts Account Management Builds relationships with significant national and regional customers and stakeholders; interfaces with key customer to understand their needs, perspective, and issues while recruiting customer sources to deliver competitive intelligence and customer insights in order to effectively guide and design effective customer strategies Delivers the Account plans and required financial results for assigned Accounts; works effectively with colleagues in other functions to achieve Account goals. Acts as a product and Account Management expert, providing advice and guidance as required to other business leaders. Pricing & Contracting Strategy Develops pricing, contracting and channel strategies for optimal patient access and profitability for assigned new and in-line products focusing on the full commercialization continuum Responsible for the strategic and financial evaluation of potential contracting efforts, support of customer negotiations and end-to end Brand payer contract execution Support the development of market access strategies for inline and pipeline products by conducting pre-modelling scenarios for market and competitor analyses, stakeholder and pricing and channel research Ethics and Compliance: Work within ethical and compliance policies and ensure those around him/her do the same Ensure a diverse and inclusive environment free from all forms of discrimination and harassment What you'll bring to the role: Minimum Requirements: Bachelor's degree or equivalent education/degree required, MBA or equivalent preferred A minimum of 6 years of pharmaceutical industry, Market Access, or payer experience Thorough understanding and knowledge of US healthcare economics and the drivers of pharmaceutical demand, including pricing and reimbursement Extensive experience in healthcare contracting and critical understanding of PBM, National and Regional Health Plan business, Medicare Part D, Medicare Part B and changing market landscape Proficient in Microsoft Office, particularly PowerPoint and Excel Proven ability to navigate complex customers and build relationships across all key stakeholders, including executive management Demonstrated prioritization, organizational and analytical skills as well as the ability to create solutions for complex processes and procedures Inspirational leadership with significant leadership experience and a high level of self-awareness and curiosity with focus on empowering others Demonstrates high degree of emotional intelligence, adaptability and creativity in solution-oriented ideation - results-oriented, fails fast to learn faster, and embodies an agile, growth mindset In-depth knowledge of patient access, launch excellence, marketing and business processes and ability to analyze complex business issues Deep understanding of US pharmaceutical value chain and its business processes Travel as required The salary for this position is expected to range between $194,600.00 and 361,400.00 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $194,600.00 - $361,400.00 Skills Desired Access And Reimbursement Strategy, Access And Reimbursement Strategy, Agility, Analytical Skill, Analytical Thinking, Cross-Functional Collaboration, Customer-Centric Mindset, Employee Development, Finance, Go-To-Market Strategy, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Influencing Skills, Innovation, Inspirational Leadership, Lcm Strategy, Market Access Strategy, Negotiation Skills, People Management, Pricing Strategy, Process Management, Product Launches, Public Affairs {+ 7 more}

This role will serve as the Associate Head of Experimental Medicine for a given TA/Function and has overall medical strategic responsibility for **Experimental Medicine Oncology / Early Clinical Development Immunotherapy.** As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + In collaboration with the Head of ExpMED TA and fellow Associate Heads, exert medical and scientific strategic leadership for the Therapeutic Area, with a focus on assets within his/her area of responsibility. + Maintain and spread knowledge of scientific developments, (products, mechanisms, methodologies) competitor strategies and external environment developments within his/her area of responsibility. + Ensures alignment regarding scientific platforms, medical communication and publication strategies as well as the Product Maintenance and Optimization strategies for each substance or project under their responsibility as delegated by TA HoEM. + Review and approve final Clinical Trial Reports, Clinical Trial Protocols, scientific publications according to established procedures as delegated by the TA HoEM. + Ensures the review of the Master Plans, related Clinical Development plans and Clinical Trial Protocols and programmes, by the CEG for each substance or project under their responsibility as delegated by TA HoEM. + Key decision maker in internal committee discussions + Serve as a member of the Therapeutic Area Licensing Advisory team, responsible for preliminary, clinical evaluation of in-licensing opportunities and oversight of in-depth in-licensing evaluations as delegated by the TA HoEM. + Manage employees belonging to his/her team and establish and maintain adequate standards of people management e.g. Training and personal development, communication, interface definition and processes. + Advise, coach and develop his/her teams regarding the preparation of key deliverables within his/her area of responsibility. + Support annual international medical budgeting process as delegated by the TA HoEM. + Supports and backs TA HoEM according to individually documented delegation of responsibilities. **Requirements** + MD or PhD from an accredited institution. + Sound clinical and scientific experience in Oncology/Early Clinical Development Targeted Therapy with ten to fifteen (10-15) years (combination of hospital, academic and industry experience),inclusive of senior leadership role/s; Clinical / pharma experience in the US a plus + Strong track record of designing trials that delivered milestones such as PoC (Proof of concept). + Expertise in Oncology translational and clinical research with focus on early clinical development (IND enabling activities through Proof of Concept studies), ideally clinical specialization hematology, oncology or organ specialist. Solid relationships with key stakeholders. + Sound medical and scientific leadership - maintains team's focus on high priority items even under constantly changing circumstances. + Proven success leading global teams preferred. + Pragmatic leader that supports and empowers teams to remove hurdles and resolve issues. + Ability to act with grace and resilience under pressure. + Excellent communication, negotiation and influencing skills. + Excellent cross-functional collaboration skills. + Full command of English Language. + Excellent presentation, training and facilitation skills. + Strong track record of interactions with regulatory affairs authority, international societies and other relevant stakeholders. + Situational Responsiveness. + Deals with Ambiguity. + Constantly learns and improves. + Advanced Management and Sound Management Skills. + Strong leadership skills. + Ability to travel globally required **Compensation:** This position, Executive Director, ExpMed Oncology Targeted Therapy, offers a base salary typically between $250,000.00 and $394,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

This role will serve as the Associate Head of Experimental Medicine for a given TA/Function and has overall medical strategic responsibility for Experimental Medicine Oncology / Early Clinical Development Immunotherapy. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities In collaboration with the Head of ExpMED TA and fellow Associate Heads, exert medical and scientific strategic leadership for the Therapeutic Area, with a focus on assets within his/her area of responsibility. Maintain and spread knowledge of scientific developments, (products, mechanisms, methodologies) competitor strategies and external environment developments within his/her area of responsibility. Ensures alignment regarding scientific platforms, medical communication and publication strategies as well as the Product Maintenance and Optimization strategies for each substance or project under their responsibility as delegated by TA HoEM. Review and approve final Clinical Trial Reports, Clinical Trial Protocols, scientific publications according to established procedures as delegated by the TA HoEM. Ensures the review of the Master Plans, related Clinical Development plans and Clinical Trial Protocols and programmes, by the CEG for each substance or project under their responsibility as delegated by TA HoEM. Key decision maker in internal committee discussions Serve as a member of the Therapeutic Area Licensing Advisory team, responsible for preliminary, clinical evaluation of in-licensing opportunities and oversight of in-depth in-licensing evaluations as delegated by the TA HoEM. Manage employees belonging to his/her team and establish and maintain adequate standards of people management e.g. Training and personal development, communication, interface definition and processes. Advise, coach and develop his/her teams regarding the preparation of key deliverables within his/her area of responsibility. Support annual international medical budgeting process as delegated by the TA HoEM. Supports and backs TA HoEM according to individually documented delegation of responsibilities. Requirements MD or PhD from an accredited institution. Sound clinical and scientific experience in Oncology/ Early Clinical Development Immunotherapy with ten to fifteen (10-15) years (combination of hospital, academic and industry experience),inclusive of senior leadership role/s; Clinical / pharma experience in the US a plus Strong track record of designing trials that delivered milestones such as PoC (Proof of concept). Expertise in Oncology translational and clinical research with focus on early clinical development (IND enabling activities through Proof of Concept studies), ideally clinical specialization hematology, oncology or organ specialist. Solid relationships with key stakeholders. Sound medical and scientific leadership - maintains team's focus on high priority items even under constantly changing circumstances. Proven success leading global teams preferred. Pragmatic leader that supports and empowers teams to remove hurdles and resolve issues. Ability to act with grace and resilience under pressure. Excellent communication, negotiation and influencing skills. Excellent cross-functional collaboration skills. Full command of English Language. Excellent presentation, training and facilitation skills. Strong track record of interactions with regulatory affairs authority, international societies and other relevant stakeholders. Situational Responsiveness. Deals with Ambiguity. Constantly learns and improves. Advanced Management and Sound Management Skills. Strong leadership skills. Ability to travel globally required Compensation: This position, Executive Director, ExpMed Oncology Immunotherapy, offers a base salary typically between $250,000.00 and $394,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities

Strategic Insights Lead Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose: The Strategic Insights Lead is a senior leader reporting to the Head, Customer Engagement Excellence. This leader is both visionary and results driven with a track record of success transforming similar organizations into customer focused teams delivering critical “run the business” insights - e.g. market intelligence, competitive insights, and forecasting - while building leading capabilities for the future. Global Insights function is core to our ability to deliver growth, enable innovation, and drive operational excellence across all regions and therapeutic areas. This role will be accountable for building people capabilities covering a broad range of activities at the global, regional and local levels that include but are not limited to brand team performance, competitive intelligence, customer insights, forecasting, impact analyses, and omnichannel execution. This leader brings a mix of advance technical skills along with an innate ability to coach and influence team members on ways to work with a variety of stakeholders - e.g. marketing, medical affairs, market access, global brand strategy, corporate strategy, new product portfolio, finance, development - while consistently delivering results. This leader will take pride in people development. With a team of ~100 across 26 regions/markets, the Strategic Insights Lead will be expected to continuously enhance the performance through technical skill improvements, stakeholder management, coaching and thought leadership development. Their teams support the insight and analytics of stakeholders in markets and above, requiring this leader to operate at levels of the organization and across the brand life cycle. Essential Job Responsibilities: Strategic Leadership Define and execute the global vision for insights and aligned with corporate strategy and long-term growth objectives. Serve as a strategic advisor to executive leadership, enabling data-informed decision-making across market, market access, medical affairs, new product portfolio, global brand, finance and corporate functions. Identify opportunities to automate reporting, forecasting, and insight generation. Thought leader responsible for defining the standards, processes and future capabilities needed to enhance our use of insights leading to decisions that better informed by data Interfaces closely with other teams across local, regional and global teams including local brand teams, asset maximization teams and hubs to ensure best practices and top skills are applied to key activities Value Delivery Insights Oversee global forecasting, performance metrics, HCP/patient journey analysis, customer insights and competitive intelligence. Build and evolve robust capabilities in primary and secondary market research, behavioural analytics, and predictive modelling. Partner with global brand leaders to support pipeline prioritization, launch excellence, and lifecycle management through insights Local Brand Team / Market Insights Oversee all local brand team insight resources including but not limited to, forecasting, performance metrics, HCP/patient journey analysis, omnichannel execution, customer insights and competitive intelligence. Lead and own (end to end) the development, implementation and continuous improvement of standardized KPIs, dashboards, and performance measurement frameworks to evaluate marketing, sales, and patient engagement initiatives. Collaborate with local operational excellence teams to meet the needs of the affiliate while maintaining consistency and comparability where possible Team & Capability Development Attract, develop, and retain top-tier talent across geographies and disciplines. Lead and mentor a high-performing, global team of insights professionals across geographies. Foster a culture of curiosity, innovation, accountability, and cross-functional collaboration. Scale global platforms, processes, and tools to enable value delivery-wide access to timely and trusted insights. Stakeholder Engagement Collaborate with key partners across marketing, medical affairs, market access, global brand strategy and growth X hub corporate strategy, new product portfolio, finance, development to unify insights strategies. Engage with stakeholders at the global, regional and local level Represent the insights and analytics function with external stakeholders, including partners, agencies, and advisory boards. Ensure global consistency while allowing for regional customization and market-specific dynamics.

As a senior leader within Medical Affairs, the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical Affairs, providing high-level guidance and operational leadership across the organization. Leveraging a deep understanding of industry trends and internal priorities, this individual will shape the development of best-in-class medical excellence capabilities aligned with Otsuka's vision, direction, and growth strategy. The Executive Director, Medical Affairs Strategy, Excellence & Operations will lead five critical teams: Strategic Planning, Business Solutions & Analytics, Vendor & Contracts Management, Governance & Procedures, and Global Medical Evidence Operations ensuring alignment with enterprise goals and medical excellence priorities. This role will champion operational rigor, foster strategic integration, and drive high-quality insights to support decision-making across the organization. Serving as a key liaison across the Global, US, and Commercial ecosystem, the Executive Director will play a pivotal role in advancing scientific and medical initiatives. Through thoughtful leadership and collaboration, this individual will shape and execute the global medical affairs strategy, optimize operational frameworks, and enable data-driven innovation across therapeutic areas. **** **Key Responsibilities Include:** **Strategic Leadership and Execution** + Serve as Chief of Staff to the VP of Medical Affairs, driving strategic alignment and operational integration across the Global Medical Affairs organization. + Sets the overall direction of Medical Excellence & Operations (MEO); make critical decisions that have impact across Global Medical Affairs therapeutic areas (TAs) and functions + Leads the development, refinement, and execution of Medical Affairs strategies and objectives in alignment with corporate goals. + Coordinates cross-functional planning, meeting cadences, budget oversight, and communication on behalf of Medical Affairs leadership. + Collaborates with cross-functional teams to align medical affairs activities with commercial and clinical development strategies + Leads Medical Excellence for Med Affairs Strategy to ensure consistent best practices across programs and drive consistent methods of strategic and tactical planning and execution. **Operational Excellence and Team Management** + Lead and manage core operational pillars within Medical Affairs Excellence & Operations Team, including: + Global Asset Strategic Planning + Business Solutions and Analytics + Vendor and Contracts management + Global Medical Evidence Operations + Governance and Procedures + Establish and implement systems, SOPs, and governance frameworks to ensure excellence, compliance, and efficiency in Medical Affairs processes (e.g., IME, ISTs, EAPs, publications, congresses) + Provide and maintain the technological infrastructure, business tools, and data analytics, including the medical information contact center, to enable Global Medical Affairs teams to operate efficiently + Oversee the department's budget, resource allocation, and vendor contracting processes (including key TA level vendors) + Will ensure assignment of Med Excellence activities/projects to Otsuka priorities + Congress Strategy/prioritization, ensure aggregation of congress plans (including meetings) and awareness cross functionally + Develop and maintain calendar of important TA meetings across programs, including congresses and internal offsite meetings (US and Global) to ensure no conflicts and adequate resourcing; will work with Administrative leads to ensure meetings are added to calendars + Develops and manages large teams driving a high-performance culture; understands the required skillset (s) needed within the medical excellence function to deliver best results + Builds relationships with key internal and external stakeholders, including industry partners **Performance Monitoring and Reporting** + Establish and track key performance indicators (KPIs) to measure Medical Affairs impact and execution + Deliver monthly and quarterly updates to Global Medical Affairs leadership and contribute to board-level reporting, as needed + Keeps abreast external environment-relevant trends and incorporates insights and best practices to inform functional decisions + Responsible for ensuring timelines and process for cross-brand initiatives, such as annual medical strategy planning, 3-year roadmaps, SMART goals **Qualifications** **Education and Experience:** + Doctorate Degree (MD (Medical Doctor), PharmD, PhD) or equivalent preferred + Minimum of 15 years' experience in the pharmaceutical or biotechnology setting within medical affairs strategy + Sr Director level medical affairs strategy experience for a minimum of 5 yrs. and experience in Medical Excellence & operations **Skills and Competencies:** + Demonstrated ability to lead and inspire high-performing teams + Strong strategic, operational, and leadership capabilities within a biotech or pharmaceutical setting + Expertise in navigating regulatory frameworks and ensuring compliance within medical affairs function + Excellent communication and interpersonal skills, with the ability to influence cross-functional teams + Strong analytical and problem-solving skills to address complex challenges within medical affairs + Ability to lead a team and influence organizational level decisions + Experience in collaborating with Medical Affairs vendors that can provide medical excellence related support + Strategic thinking acumen and record of accomplishment for operational excellence + Ability to rapidly pivot based on evolving corporate strategy and direction + Proficiency in pharma code and all guidelines concerning medical affairs activities + Excellent presentation skills and ability to communicate complex scientific information + Motivated, disciplined, pro-active individual capable of effectively managing timelines **Other Requirements:** + Ability to travel globally up to 25% for congresses, advisory board meetings, Governance meetings as business needs require **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.

The Director, Value & Access Strategy leads the strategy and tactical development supporting our market access customers. This encompasses corporate approach recommendations for existing and emerging channels, bridging pipeline market access strategies to inline, Therapeutic Area initiatives and is accountable for all brand payer related initiatives for the portfolio working closely with the brand teams. **** + Develop and lead a cross-portfolio approach to market access customers + Develop an CNS wide portfolio value proposition for market access customers + Lead the team to develop and implement payer pull-through material + Lead the team to develop and refine the payer value proposition for inline brands + Collaborate with Commercial team to ensure payer value drivers are incorporated into all payer marketing initiatives + Continually evaluate Market Access strategies for pipeline products by partnering with Medical Affairs, Value and Evidence and the Market Access team while effectively bridging them to inline marketing support + Direct Brand specific Payer/Advocacy Market research activities with CSI colleagues + Manage Payer Marketing budget resources + Lead market access channel assessments and build recommendations on the best way to approach our existing channels + Lead the assessment and development of new channel enhancement + Manage key Agencies of Record to deliver tools and tactics + Engage, inform and influence key stakeholders + Collaborate closely with brand marketing teams + Engage with Regional Senior Business Directors as the business dictates + Contributes to the development of direct report + Travel expected up to 20% **Qualifications** Required: + Bachelor of Arts (BA) or Bachelor of Science (BS) degree from an accredited four-year college or university (or the equivalent if education obtained outside of the United States) + 10+ years pharmaceutical experience in sales or marketing with at least 6+ years of market access responsibilities and successful track record + Solid track record of driving market access initiatives within an organization + Strong interpersonal skills and ability to work effectively in a matrix team environment + Excellent planning and strategy development while executing against tight timelines + High emotional intelligence in managing multiple business initiatives and cross-functional relationships + Strong communication skills, both verbal and written + Strong organizational and project management skills Preferred: + MBA or master's degree preferred + Knowledge of payer and access stakeholder needs in the US preferred **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 $183,335.00 - Maximum $274,160.00, 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.

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. **J** **ob 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. **K** **nowledge, Skills, and Competencies** **K** **nowledge** - 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) **P** **hysical 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 $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 Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel. **** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products. + Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes. + Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. + Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus. + Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. + Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. + Performs other duties as assigned related to CMC RA function. **Qualifications** **Education** : + BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products. + Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications will be a plus. **Skills:** + Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues. + Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval. + Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. + Comprehensive understanding of the global regulatory environment. + Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. + Strong leadership, communication, and negotiation skills. + Ability to manage complex projects and timelines across multiple regions. + Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + CMC reviewer (assessor) with FDA or EMA will be a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $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.

**Company Background/Culture** Otsuka 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 for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas. **Culture** As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed. Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility. **Pipeline** Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products. You can learn more about Otsuka by clicking here! (******************************************* **** **Position Summary** Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings. **Key Job Responsibilities** + Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation. + Serve as the medical lead and subject matter expert for assigned indications. + Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes. + Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees. + Lead clinical discussions with KOLs and advisory boards. + Develop clinical documents including medical monitoring plans, asset development plans + Contribute to development of publication plans and review scientific manuscripts for publications. + Mentor and provide leadership to junior team members within the organization. + Support business development activities through medical due diligence and evaluation of external opportunities. + Contributes to corporate initiatives by participating in continuous process improvement to meet company **Knowledge, Skills, Competencies, Education, and Experience** Required: + A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician. + Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia). + Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing). + An advanced understanding of clinical medicine and science. + Advanced understanding of drug development principles and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and commercialization. + Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting. + Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies, + Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus. + Ability to work across different therapeutic areas and different stages of clinical development. + Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants). + Strong communication and presentation skills. + Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Knows how/when to apply organizational policy or procedures to a variety of situations. + An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including: + Flexibility in working across different therapeutic areas and experience in different stages of clinical development. + Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage. **Physical Demands and Work Environment** + Travel (~30-35%) + See document Physical Demands and Work Environment for further requirements. **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.

The Senior Director, Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned Central Nervous System (CNS) therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy. The role is a key leadership position within the CNS Business Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. **** **Key Responsibilities:** **Global Scientific Communication Strategy** + Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the CNS portfolio aligned to the overall medical strategy + Collaborate with the CNS Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment + Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements + Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models **Content Development Oversight** + Provide executive oversight for and ensure the strategic alignment of all CNS medical affairs communication materials, including but not limited to + Scientific Communications Platform (SCP) + Global Publications Strategy + Global Medical Publications Plan + Core Disease State Deck + Core Field Materials + Medical Publications + Integrated Medical Communications Planning + New Data Reporting + Medical Information Content Generation **Publications Strategy** + Direct strategic vision and ensure execution of the global publication plan for CNS assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals + Direct agency and vendor relationships to deliver high quality publication deliverables **Congress Planning** + Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs) + Ensure coordinated scientific messaging and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles **Medical Information Content Generation:** + Oversee the creation, review, and approval of high-quality medical information content, including standard response letters, FAQs, global core content, and scientific response documents. + Ensure all content is scientifically accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to ensure consistency and alignment of messaging across channels. + Drive the development and implementation of content governance frameworks, version control processes, and global-to-local adaptation strategies. + Manage external vendors and medical writing agencies to ensure timely and high-quality content delivery. + Provide leadership and mentorship to a team of medical writers, content strategists, and reviewers, fostering a culture of excellence and continuous improvement. + Monitor and analyze content performance and stakeholder feedback to inform future content strategy and optimization. + Consider technology and AI to support workflow improvement **Cross-Functional Leadership** + Act as a thought leader and senior advisor on core CNS team meetings, aligning communication plans with CNS BU Medical Strategy and influencing enterprise-wide decisions + Partner closely with the US Field Medical Affairs Lead to ensure the field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy + Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education + Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Neuroscience or a related CNS field + Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry + Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function + Demonstrated track record of defining and directing enterprise-level global and/or US communication strategies for a marketed or late-stage development product, preferably in CNS therapeutic areas + Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale + Previous experience overseeing or leading medical information groups is a plus. **Skills and Competencies:** + Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level + Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making + Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress) + Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners **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 $225,490.00 - Maximum $337,180.00, 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 Senior Director, Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific communication strategy for the assigned Nephrology & Immunology therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy. The role is a key leadership position within the Nephrology & Immunology Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. The role reports directly into the Executive Director, Nephrology & Immunology Business Unit Lead. **** **Key Responsibilities:** **Global Scientific Communication Strategy** + Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the Nephrology & Immunology portfolio aligned to the overall medical strategy (developed by the medical strategy team) + Collaborate with the Nephrology & Immunology BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment + Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements + Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models **Content Development Oversight** + Provide executive oversight for and ensure the strategic alignment of all Nephrology & Immunology medical affairs communication materials, including but not limited to + Scientific Communications Platform (SCP) + Global Publications Strategy + Global Medical Publications Plan + Core Disease State Deck + Core Field Materials + Medical Publications + Integrated Medical Communications Planning + New Data Reporting + Medical Information Content Generation **Publications Strategy** + Direct strategic vision and ensure execution of the global publication plan for Nephrology & Immunology assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals + Direct agency and vendor relationships to deliver publication deliverables **Congress Planning** + Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs) + Ensure coordinated scientific communication objectives and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles **Cross-Functional Leadership** + Act as a thought leader and senior advisor on core Nephrology & Immunology team meetings, aligning communication plans with Nephrology & Immunology BU Medical Strategy and influencing enterprise-wide decisions + Partner closely with the Global Field Medical Affairs Lead to ensure the global field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy + Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education + Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function + Consider technology and AI to support workflow improvement + Manage and mentor a team of medical writers and communication professionals, fostering excellence, innovation, and continuous development. **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in a Nephrology & Immunology related field + Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry + Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function + Demonstrated track record of defining and directing enterprise-level global communication strategies for late-stage assets and an emerging portfolio, preferably in Nephrology & Immunology therapeutic areas + Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale + Previous experience overseeing or leading medical information groups is a plus **Skills and Competencies:** + Strong ability to present to executive leadership team + Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level + Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making + Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress) + Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners + Knowledge of digital platforms and tools for medical content delivery and engagement **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 $225,490.00 - Maximum $337,180.00, 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.

- Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and driving efficiency across Global Quality's processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ systems, future processes and teams. - The Sr. Director position will facilitate continuous improvement activities within GQ leading special pilots, prototypes, collaborations and projects to digitalize the Knowledge and Document management processes. - The Sr. Director of GQS liaises with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance the digital transformation of the entire GQ workspace (across GXP) via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state-of-the-art data insights. - The Sr. Director brings industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to deliver a strategic roadmap that will bring and maintain Otsuka's Quality Knowledge and Document Management practices to a best in class - digitalized landscape. Key job responsibilities - Develop a roadmap to drive Knowledge Management to an automated, digitized and ever-green environment - digitalizing the processes and practices of Document Management (i.e. Iron Mountain) and eliminating (or significantly minimizing) any paper archive. - Applying technology intelligence and understanding of the process enhancement requirements, determine opportunities for optimization of existing systems and identifying the need for new solutions - Addressing digitization of paper documents across the ecosystem of GQ to enable e-archiving and e- access and retrievability. - Design and employ a digital and automated GQ work flow across the enterprise of the GQ business function. - Drive a culture of Quality Innovation awareness - Benchmarking external opportunities and innovation advancements and ensuring Otsuka GQ is at the cutting edge of the use of innovative processes, practices, solutions and technology to drive optimal operational efficiency and effectiveness. - Collaborate with external parties to understand the current industry landscape and endorse/apply best in class practices and solutions to Otsuka GQ system portfolio and business operations. - Lead the design and execution of complex GQ optimization initiatives; including - detailed program planning, well-defined business cases, clear value proposition, the management of applicable collaborators and identification/leveraging of applicable external expertise. - Evaluate, measure and document time, resource and cost optimizations of continuous improvement and transformational activities to ensure improved efficiency and effectiveness over time. - Identify and pursue opportunities through internal and external collaborations to optimize Knowledge and Document Management, GQ processes, the timeliness and quality of GQ deliverables, and GQ resource requirements using transformational technologies such as, Robotics Process Automation, Machine Learning, Artificial Intelligence and Blockchain capabilities. - Travel (approximately 10-25%) Qualifications - Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with a minimum of 5 years of applicable health care, technology or industry is experience strongly preferred. - Advanced analytic skills, and general understanding of the drug development and regulatory process. - Successful track record of leadership and timely delivery of innovative business deliverables. - Strong communication, interpersonal and alliance management skills; possessing the ability to credibly, knowledgeably and effectively represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka's partners and clinical trial personnel. - Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka's competitive edge. - Ability to work effectively in a matrixed, multi-cultural, collaborative and self-directed environment. - Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Training COE will lead the creation and execution of a Center of Excellence (CoE) for GxP & non-GXP learning and development. The role will oversee a global team dedicated to designing and delivering best-in-class training programs in GxP compliance, Ethics & Compliance, and Pharmacovigilance, ensuring alignment with regulatory requirements and business objectives. This strategic leader will be responsible for transforming the employee training experience by driving innovation, standardization, and operational efficiency across the organization. **Key Responsibilities** + Establish and lead a Global Learning & Development Center of Excellence, setting the vision, strategy, and governance for enterprise training programs. + Design and implement a modern, scalable, and engaging training ecosystem that enhances employee learning experiences and supports regulatory compliance. + Oversee the development and global deployment of training programs in: + GxP (Good Manufacturing/Clinical/Laboratory Practice) compliance + Ethics and Compliance + Pharmacovigilance + Partner with Quality, Regulatory, R&D, Manufacturing, Supply Chain, and IT to ensure training programs are aligned with business needs and evolving regulatory expectations. + Drive process optimization and digital transformation in training delivery, leveraging learning technologies (e.g., LMS, LXP, AI-based learning tools). + Ensure global training programs meet regulatory inspection readiness and support audit preparedness. + Develop and monitor key performance indicators (KPIs) to measure training effectiveness, compliance, and continuous improvement. + Lead and develop a high-performing global L&D team, fostering a culture of innovation, accountability, and excellence. + Stay current with industry trends, adult learning methodologies, and regulatory changes to inform strategy and maintain a competitive edge. **Qualifications** Required + Bachelor's degree in Life Sciences, Education, Organizational Development, or related field + Minimum 15+ years of progressive experience in Learning & Development, with at least 5 years in a senior leadership role in a regulated industry (pharmaceutical, biotech, or healthcare). + Deep understanding of GxP, Ethics & Compliance, and Pharmacovigilance training requirements in a global pharmaceutical environment. + Proven experience establishing and scaling a global L&D function or Center of Excellence. + Strong knowledge of learning technologies, including Learning Management Systems (LMS), content authoring tools, and digital learning platforms. + Demonstrated success in leading global teams, managing complex projects, and driving cultural and operational change. + Excellent communication, stakeholder engagement, and strategic planning skills. Preferred + Experience with regulatory inspections and training documentation for agencies such as FDA, EMA, MHRA, and PMDA. + Certification in Instructional Design, Adult Learning, or Organizational Development. + Familiarity with AI-driven learning platforms and data analytics in training. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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.

**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, Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role will direct Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **** + Responsible for directing quality oversight of GMP contract manufacturers of Otsuka clinical and commercial products. + Develops comprehensive quality strategies for complex biologic development programs that address unique manufacturing challenges. + Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product). + Transforms biologic manufacturing quality challenges through innovative approaches that maintain product integrity while optimizing operational efficiency. + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance. + Manages reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests. + Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above. + Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. + Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc. + Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP. + Assists in conducing audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable regulatory requirements. + Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met. + Serves as a Global Quality Product Champion with a focus on ensuring the quality of our biologics products, monitoring, and escalation of any situations with potential negative impacts on clinical study supplies, supply chain for commercial products, or patient safety. **Qualifications** Required + Bachelor's degree in Chemistry, Biology or other Physical Sciences. + Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial product and development project activities. + Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects. + Proven experience with biologics GMP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes. + Expertise in conducting root cause investigations and driving CAPA implementation. + Ability to supervise multiple direct reports and projects in a fast-paced environment. + Demonstrated success in working on and leading cross functional teams. + Experience with Pre Approval Inspections for NDAs and BLAs. + Experience in driving continuous improvement projects. + TrackWise Experience. + Excellent interpersonal and communication skills. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Advanced degree in Biology or other Physical Sciences. + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Associate Director, Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP quality practices across the global organization. This role defines, maintains continuously improves critical quality system elements including **Product Quality Complaints (PQC), Corrective and Preventive Actions (CAPA), Deviations, and Change Control** , ensuring compliance with global regulatory requirements and internal standards. The successful candidate will lead cross-functional initiatives to enhance quality performance, reduce risk, and foster a culture of continuous improvement. **Key Responsibilities** + Process Ownership & Governance:Lead the global strategy and governance for Product Quality Complaints, CAPA, Deviations, and Change Control processes. Develop and implement global standards, procedures, and best practices to ensure consistency and compliance across all global affiliates. Partner with regional and site quality leaders to drive process improvements, enhance efficiency, and ensure alignment with corporate quality objectives + Cross-functional Leadership:Collaborate with Regulatory Affairs, Technical Operations, Manufacturing, and Supply Chain to ensure alignment and integration of quality into product lifecycle activities. + Quality Strategy Development:Lead or support global projects related to digital transformation, system upgrades, and process optimization. + Inspection Readiness & Compliance:Support regulatory inspections and internal audits, ensuring readiness and robust documentation of quality system performance. + Metrics and Reporting: Monitor and report on key performance indicators (KPIs) to senior leadership, identifying opportunities for improvement and risk mitigation. + Training & Change Management:Provide leadership, coaching, and subject matter expertise to global teams on GMP compliance and quality system execution. **Qualifications** Required + Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or related field (Master's or PhD preferred). + 8+ years of experience in pharmaceutical quality, regulatory affairs, or technical operations. + Proven expertise in managing and optimizing PQC, CAPA, deviation, and change control systems. + Experience leading cross-functional teams and global projects. + Skills & Competencies: + Strong knowledge of GMP, ICH guidelines, and global regulatory requirements. + Strong analytical skills with experience in quality metrics, risk management, and root cause analysis. + Excellent project management, communication, and stakeholder engagement skills. + Strategic thinker with a continuous improvement mindset. + Proficiency in quality systems and digital tools (e.g., TrackWise, Veeva). Preferred Experience: + Certification in Lean, Six Sigma, or Quality Auditing. + Experience in global matrix organizations and cross-cultural collaboration. + Knowledge of digital transformation in quality processes **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.