generalcontractor jobs in Sioux Falls, SD

The Associate Director, Scientific Communications manages the execution of the core scientific and medical communications strategy for the relevant therapeutic area portfolio. This role is accountable for delivering operational results by overseeing the creation of core content assets and managing the global publications plan. This position provides guidance, coaching, and oversight to the Manager, Medical Core Content, ensuring all materials are developed with scientific accuracy, consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:** **Global Scientific Communication Strategy** + Manage and deliver a comprehensive, globally aligned medical communications strategy and tactical plan for the relevant therapeutic area portfolio, in partnership with the Senior Director, Medical Communications Lead, CNS Lead, and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial). **Content Execution Direction** + Provide guidance, coaching, and oversight over the work of the Manager, Medical Core Content, managing and ensuring the development of core scientific content, including: + 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 Execution** + Drive publication strategy: oversee planning, execution, and dissemination of key data through peer-reviewed journals and congresses. + Manage and oversee the execution of the global publication plan for assigned CNS assets + Coordinate with investigators, medical writers, and the Senior Director to ensure timely and compliant submission of high-quality abstracts, posters, and manuscripts in line with Good Publication Practices (GPP) and the overarching publication strategy + Oversee vendor relationships including selection, contracting, and budget management for medical communication agencies **Medical Information Content Generation:** + 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. + Serve as a champion and lead Medical Review / Promotional review processes for materials + Manage the 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 managers, 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 **Scientific Narrative Ownership** + Manage and provide direction for the core scientific lexicon and messaging, ensuring its consistent application across all Medical Affairs materials through clear guidance to the Manager of Core Content **Cross-Functional Collaboration** + Partner closely with Clinical Development, Global Integrated Evidence & Innovation, and Regulatory teams to gather and accurately interpret new data, ensuring the Manager of Core Content applies this information consistently and accurately into communication materials + Support the US Field Medical Affairs Lead by ensuring the Manager of Core Content develops and maintains a high-quality, scientifically rigorous, and compliant content repository for the field team + Manage the operational execution and day-to-day budget for external medical writing and communications agencies that support content and publication deliverables **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 the relevant therapeutic area. + Minimum of 7 years of experience in Medical Affairs or Scientific Communications within the pharmaceutical or biotechnology industry + Minimum of 3 year of experience providing guidance, coaching, or oversight to a direct report, junior team member, or significant project team + Extensive hands-on experience in medical writing and managing the development of core scientific content (e.g., slide decks, scientific platforms) for global use + Demonstrated experience in publication management, including coordinating authors, overseeing submissions to journals/congresses, and adhering to GPP standards + Previous experience overseeing or leading medical information groups is a plus. **Skills and Competencies** + Demonstrated ability to provide guidance, coaching, and mentorship to a direct report, delegate tasks effectively, and maintain accountability for project quality + Exceptional ability to interpret complex clinical and scientific data and apply it consistently and accurately across communication materials + Strong ability to navigating complex data and evolving treatment paradigms in psychiatry and neurology + Strong organizational skills with the ability to manage multiple simultaneous project workflows (content and publications) and drives improvements to development processes + Excellent interpersonal skills with the ability to communicate scientific strategy clearly to both internal experts and external vendors/authors & tailor communications to address unique challenges in the relevant therapeutic area (e.g., stigma, patient diversity, long-term outcomes). **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.

Job Description Summer 2026 Internship Opportunity - Data Scientist Intern Are you ready to turn data into decisions? CAPITAL Services is excited to offer a Data Scientist Internship for Summer 2026! This is a fantastic opportunity to gain hands-on experience in a dynamic, data-driven environment where your insights can make a real impact. As a Data Scientist Intern, you'll work closely with our talented Decision Intelligence Analysts and Data Scientists on meaningful projects in the following areas: Risk Analysis Model and Strategy Development Model Validation MIS Reporting Throughout the paid 12-week program (beginning May 2026), you'll receive a variety of training opportunities to strengthen your skills in statistical analysis and business intelligence. This internship is onsite in Sioux Falls, SD, offering you the chance to collaborate directly with our team and experience our company culture firsthand. Qualifications: Junior level or higher in Mathematics, Data Science, Statistics, or a related discipline Minimum 3.0 GPA Strong attention to detail and self-motivation Excellent verbal and written communication skills Authorized to work in the United States on a permanent basis Preferred Skills: Familiarity with tools such as R, SQL, or SAS Interest in pursuing graduate studies in statistics or a related field Successful completion of an analytics or data-focused project Why Join CAPITAL Services? Work on real-world challenges with measurable impact Learn from experienced professionals in a supportive environment Build your resume with meaningful experience in data science Explore future career opportunities within our organization At CAPITAL, we are committed to connecting people with convenient purchasing power for life's needs. We value using data to make strategic decisions that drive our business forward. This unique approach is what sets us apart and enables us to better serve our employees, customers and clients each day. Are you looking for a company who strategically uses data in all aspects of their business? We invite you to apply by clicking on the on the apply button above and using the navigational buttons to complete the application process.

The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, supports audit and inspection readiness, and collaborates with internal teams and external partners to maintain high-quality standards throughout the clinical development lifecycle. **Key Responsibilities** **Clinical Study Support** + Serve as a GCP quality resource to clinical teams during study planning, conduct, and close-out. + Support the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance. + Assist in identifying and resolving quality issues, protocol deviations, and potential noncompliance. + Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices throughout the study lifecycle. **Inspection Readiness** + Support inspection readiness activities including mock audits, documentation reviews, and training coordination. + Maintain inspection readiness tools, trackers, and communication plans. + Participate in regulatory inspections and assist in preparing response documentation. **Audit Program Execution** + Contribute to the development of the annual audit plan using risk-based approaches. + Coordinate and support investigator site, vendor, and internal process audits. + Track audit findings and ensure timely implementation of corrective and preventive actions (CAPAs). + Monitor audit trends and escalate recurring issues to senior leadership. **Quality Systems & Compliance** + Support the implementation and continuous improvement of clinical quality systems, SOPs, and policies. + Assist with deviation management, root cause analysis, and CAPA tracking related to clinical activities. + Stay current with evolving global GCP regulations and industry best practices. **Collaboration & Team Support** + Partner with internal stakeholders and CROs to ensure consistent quality oversight. + May mentor junior staff or contractors. + Contribute to cross-functional initiatives that promote a culture of quality and compliance. **Qualifications** Required + Bachelor's degree in life sciences or related field; advanced degree a plus. + 6-8 years of experience in clinical quality assurance or clinical research within the pharmaceutical or biotech industry. + Solid understanding of GCP, ICH guidelines, and global regulatory requirements. + Experience supporting inspection readiness and participating in audits or inspections. + Strong communication, organizational, and problem-solving skills. + Ability to travel domestically and internationally as needed. + Proficiency in MS Office (Word, Excel, PowerPoint). **Preferred:** + Experience with TrackWise or similar quality management systems. + Prior collaboration with CROs and external vendors. + Exposure to FDA or other health authority inspections. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Clinical Consultant / Clinical Educator for Critical Care Monitoring Devices and Clinical Applications Full-Time Traveling opportunities for candidates in California metropolitan areas. Are you a Critical Care RN who loves your healthcare career but need a change from the everyday grind of the bedside? Are you a leader who enjoys providing education to your peers? Ever wonder what it would be like to travel, explore new environments, while meeting and training new colleagues? If so, we invite you to partner with us for an opportunity as a traveling Clinical Educator! Our Clinical Solutions division offers a unique and exciting professional growth opportunity in the medical device and clinical information systems arena. We provide clinical application support for the world's top patient monitoring device company. Our full-time Educators travel to healthcare facilities to provide end-user training, configuration, and go-live support. We and our client are committed to your success! The orientation for this role is typically 6 months long and includes classroom and field training. You will learn a lot about yourself, healthcare management and operations, and an assortment of clinical practices and implementations. You can become an expert in the latest healthcare technology and develop or enhance many professional skills. We are not a recruitment agency and these positions are benefit eligible. Our full-time benefits include: paid time off, health, dental, vision, and life insurance; short and long-term disability, 401k and more. A corporate credit card is available for business travel expenses! If you have the qualifications listed below and a commitment to the requirements, all you need to bring is yourself and enthusiasm! Availability and Travel requirements: * Schedule requirements: Maintain availability (48+ weeks per year) of 4-5 days per week between Monday and Friday, plus travel. Must be available for departure travel on Sundays to return on Thursdays or Fridays; OR, departure on Mondays to return on Fridays or Saturdays. And, must be willing to work 5 days per week, 50% of the time, when assignment needs are longer than the 4 days. * Readiness and willingness to work all shifts (Days, Evenings, and Nights) without disinclination or declination. * Ability to travel for several consecutive overnights across the California State territory. * Must live within 1 hour of a major US airport for air travel needs (including willingness to fly regional jets) and have access to reliable transportation for drivable assignments 4-5 hours from home. * Currently live in a California metropolitan area Position Duties and Responsibilities: * Travels to customer sites to educate and support healthcare professionals in operating their critical care monitors proficiently and safely. * Configures or design monitor set-up per client company directed parameters and customer consultation. * Provides post-sales end-user education classes/in-services. * Delivers go-live support with new monitors or upgrades. * Upholds customer focus by proactive assessment and appropriate communication/escalation of customer needs and solutions. * Communicates with client company Clinical Specialists and completes documentation, as required. * Maintains competency on product via company provided training events (classroom training, online learning modules, etc.) * Optimizes travel strategies for cost savings. * Maintains successful completion of corporate and client training modules. * Completes expense and hourly reports as outlined. * Meets and maintains vendor credentialing requirements with immunizations and related medical requirements. * Sustains current driver's license and acceptable driving record

This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.

Join our team as a Processing Coordinator and play a key role in keeping our egg production operations running smoothly. This position offers a fast-paced, hands-on work environment with opportunities for growth and development. Forecast and Coordinate: Plan plant production (Longs and Shorts) and communicate facility needs in advance to ensure smooth operations. Manage processing instructions and raw material inventory to maintain a resilient supply chain. Use forecasting to minimize last-minute changes, reduce complexity, and prevent shortages. Maintain a Safe and Clean Work Area: Keep your workspace organized, promptly pick up any dropped eggs or debris, and dispose of waste properly. Communicate: Share potential issues early and propose solutions to help reduce stress and improve overall team efficiency. Teamwork: Support your team and collaborate to achieve common goals. Pay: $19/HR and up DOE Shift: 1st Hours: 6am-3:30pm M-F Why work for Advance Services, Inc. Advance Services is for and about people; we are your employment specialists. Enjoy our easy application process. You NEVER pay a fee! Weekly pay. Fun Safety and attendance incentives. Health Benefits to keep you and your family healthy. Great Referral Incentives. Advance Services partners with the top companies in the area! Apply for this job by clicking the apply button. You will be directed to our website, *********************** Please select a branch near you or call our office at ************. Stop in and see our experienced, bilingual, and friendly staff today at 1800 Broadway, Yankton SD 57078. Advance Services is an equal opportunity employer #103

The National Director, Rare Disease is a senior leadership position accountable for setting the US strategy, operational oversight, and performance management of the Rare Disease Field Medical Affairs (FMA) team. This role manages the unique challenge of strategically deploying a small MSL team across a disparate rare disease presence (including PKU and ALS), ensuring effective scientific exchange, supporting identification for evidence generation needs, and collaboration with patient advocacy and policy teams to ensure strategy reflects patient perspectives. The Director is responsible for medical customer engagement, including the hiring, development, coaching, and strategic deployment of the Rare Disease MSLs (including the PKU and ALS MSLs). This position reports directly to the Rare Disease Medical Business Unit Lead. **** **Key Responsibilities:** **Leadership and People Management** + Oversee the recruitment, on-boarding, training, and performance management processes, including development of performance metrics, for the Rare Disease FMA team, ensuring all personnel meet high professional and scientific standards + Lead, mentor, coach, and support performance management of the national team of Rare Disease MSLs, fostering a culture of scientific excellence, accountability, and patient focus + Manage the US FMA budget, resource allocation, and key operational metrics to optimize field effectiveness and efficiency + Represent stakeholder needs, insights, and knowledge to other parts of Otsuka including senior leadership and other internal partners **Strategic Deployment and Stakeholder Engagement** + Develop and implement the overarching US FMA strategy and annual operating plan, focusing on strategically deploying MSLs to cover a disparate rare disease presence and small patient populations + Direct the team's efforts to identify centers and/or patients suitable for evidence generation (e.g., registries), recognizing the significant recruitment challenges inherent in rare diseases + Ensure MSLs effectively interact with multidisciplinary care teams of specialists (e.g., metabolic specialists for PKU, neuromuscular specialists for ALS) to foster comprehensive scientific exchange + Lead the strategy for connecting with key external stakeholders, including patient advocacy groups at national and international congresses, ensuring coordinated scientific coverage and efficient resource use + Maintain relationships with key opinion leaders, healthcare professionals, and key accounts to facilitate scientific exchange, and will act as the primary point of contact for these external stakeholders. **Operational Excellence** + Maintain accountability for ensuring all field activities, scientific exchanges, and documentation adhere to relevant company SOPs, regulatory requirements, and industry guidelines + Monitor key performance indicators (KPIs) and operational metrics for the national team, using data to drive continuous improvement in scientific and medical customer engagement, efficiency, and insight collection + Oversee the consistent capture, aggregation, and synthesis of high-quality medical insights from the field to inform internal strategic decision-making within Medical Affairs and across the broader R&D organization + Consider technology and AI to support workflow improvement **Cross-functional Integration** + Serve as the primary field medical affairs representative to the Rare Disease Medical Business Unit Lead and core cross-functional leadership team (e.g., Commercial, Market Access, etc.) + Coordinate with the Clinical Development team to support site identification, feasibility assessments, and operational excellence for clinical trials within the Rare Disease space **Compliance and Training** + Ensure all activities adhere to applicable regulations, compliance, guidelines, and industry standards. + Stay abreast of relevant regulatory and legal developments, providing guidance and training to the team as needed. + Able to fulfill required internal company training requirements in a timely manner **Qualifications** **Education and Experience:** + Advanced scientific or clinical degree is required (PharmD, MD, PhD, or equivalent) + Minimum of 10 years of field experience in the pharmaceutical or biotechnology industry + Minimum of 3-5 years of direct people management experience leading a field-based MSL team (Regional or National responsibility required) + Extensive experience in Rare Disease or a highly specialized therapeutic area with complex patient journeys and limited physician specialists + Proven success in developing and executing national medical strategies, budget management, and clinical trial support **Skills and Competencies:** + Exceptional ability to lead, motivate, and manage a remote, high-performing scientific team + Strong ability to lead, influence, and collaborate in a matrixed environment regardless of reporting structure and operating under ambiguity without a set playbook. + Superior strategic planning and organizational management skills, capable of translating broad strategy into tactical execution plans under constraints of a small team size + Deep understanding of the Rare Disease patient and provider ecosystem, including multidisciplinary care models, patient advocacy, and diagnostic pathways + Excellent communication, presentation, and cross-functional leadership skills, with proven ability to influence + Ability to travel at least 60% - attend regional and international conferences / workshops to obtain new competitive information, keep abreast of clinical trends and support, and maintain relationships with key investigators and scientific research **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $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 Executive Director, Global Value Evidence Lead, is a strategic leader responsible for driving the global value evidence strategy across the company's portfolio. This senior leader will provide strategic vision and leadership for value evidence activities at Otsuka, ensuring robust, innovative, and fit-for-purpose evidence is generated to support product differentiation, market access, and reimbursement across geographies. The incumbent will lead a team of value evidence asset leads and collaborate with internal and external stakeholders to shape the value narrative and evidence plans from early development through post-launch. **Key Responsibilities:** + Oversee the Global Value Evidence (GVE) strategic planning and execution processes to ensure alignment with asset and company business priorities + Lead team of value evidence TA and assets leads who design and implement HEOR, RWE, and other evidence generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate the differentiated value of our products + Utilize advanced scientific knowledge and emerging trends to drive innovation in value evidence + Provide mentorship, support in career development and performance management for direct reports + Enhance the department's capabilities by developing skills, nurturing a culture of scientific excellence, and ensuring strategic impact + Support in proactively identifying and solving complex problems that impact the management and direction of the GVE department + Cultivate strong, collaborative relationships with key internal stakeholders and communicate matters of significant importance to the department, broader function and organization + Represent the company in external engagements with HTA bodies, payers, academic institutions, and industry consortia. + Ensure compliance with global regulatory and ethical standards in evidence generation and data use. **Qualifications:** + Advanced degree (PhD, PharmD, MD, MPH, or equivalent) in a relevant scientific or health-related field. + 10+ years of experience in pharmaceutical, biotech, or healthcare consulting, with a strong focus on HEOR, RWE, and market access strategy. + Demonstrated leadership in developing and executing global evidence strategies for successful product launches and access. + Recognized within the outside scientific community as a thought leader in value evidence through publication in peer reviewed journals, presentations, involvement in scientific/professional associations etc. + Deep understanding of global HTA and payer requirements, regulatory frameworks, and healthcare systems. + Deep understanding of industry best practices + Exceptional strategic thinking, communication, and stakeholder engagement skills. + Proven ability to lead cross-functional teams and influence senior leadership. **Preferred Qualifications:** + Experience in multiple therapeutic areas, including specialty or rare diseases. + Familiarity with innovative evidence platforms, digital health technologies, and advanced analytics. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Director, Strategy & Analysis; Contract Operations works cross-functionally to develop and execute pricing strategies for pipeline and in-market products and manages contract operations to optimize revenue, market share, and support patient access. Leads and conducts pricing analysis of current and proposed governmental policies with respect to impact on pipeline and in-market portfolio products. In addition, this role is responsible for implementing and evolving contract operations to support the company's market access strategy. Leads an operations team and third-party vendor in executing rebate invoice validation and payment, Gross to Net (GTN) forecasting, and government price reporting. Leads team to accomplish business objectives while ensuring compliance with all relevant policies and procedures. **Strategy & Analysis:** Supports development of market access strategies for in-market and pipeline products. Works cross-functionally to develop pricing and associated contracting strategies for pipeline and in-market products. Partners with Insights & Analytics team to assess impact of payer access controls and price on in-market and pipeline products. Works closely with Government Affairs to model/assess policy scenarios and evaluate the financial impact to Otsuka for both in-market and pipeline products. **Contract Operations:** Implements and evolves contract operations to support the company's market access strategy. Oversees rebate invoice processing including validation to prevent revenue leakage and payment processes. Includes oversight of third-party vendor supporting the process. Oversees Government Pricing operations including the third-party vendor to ensure all calculations and processes are performed according to approved policy and procedures. This includes ensuring accurate reporting and timely internal communications to ensure alignment. Ensures all deadlines are met and delivers effective overall operations. Oversees the process and third-party vendor for State Price Transparency Reporting. This includes establishing a process for monitoring state requirements, proactively identifying Otsuka's requirements, and leading the development of reports through the approval and submission process, informing leadership of relevant changes with recommendations regarding Otsuka's actions. Ensures accurate and timely report submissions and maintenance of historical records. Leads review of Government Pricing policy, SOP's and SOX compliance documents on an on-going basis and updates as necessary. Oversees GTN forecasting in support of budget and forecast processes as well as assessments of strategic scenarios to determine impact on GTN; recommends optimal GTN approach. Establishes KPIs to assess efficiency and impact of operations. **People Management:** Leads a team to achieve agreed to goals, while ensuring compliance with regulations and policies. Develops and improves team skill sets through formalized training as well as through formal and informal feedback; ensures team is receiving continuing education in customer and market knowledge. Supports team members in career development and establishes a succession plan. **Ethics and Compliance:** · Ensures compliance with all applicable policies and ensures those around him/her do the same. **Qualifications** **Skills and Experience:** + A minimum of 10+ 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 + Deep understanding of US pharmaceutical value chain and its business processes + Extensive experience in healthcare contracting and in-depth understanding of GPO/PBM/National and Regional Health Plan business models, Medicare Part D, Medicare Part B, 340B, and the changing market landscape + In-depth knowledge of patient access, launch excellence, marketing and business processes + Strong government pricing knowledge and experience + Strong financial acumen, forecasting, and modeling abilities + Proven ability to navigate complex customer contract negotiations + Ability to drive cross-functional collaboration and strategic alignment across multiple teams + Excellent communication and executive presentation skills + Demonstrated ability to create solutions for complex processes and procedures + Inspirational leadership ability including a high level of self-awareness and curiosity as well as a 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 + Proficient in Microsoft Office, particularly Excel and PowerPoint **Education:** Bachelor's degree or equivalent education/degree required, MBA or equivalent 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 $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 of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the impact of regulatory changes to the pharmaceutical environment. **** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated regulations and guidance that may impact pharmaceutical practices, procedures and controlled documents. + Lead weekly regulatory intelligence team meetings to include review and discussion of ad hoc query requests, regulatory background package requests, health authority guidance, Federal Register notices, public commenting opportunities, and newsletter content. + Manage development and distribution of weekly regulatory intelligence newsletters and regulatory watch notifications. + Ensure regulatory intelligence specialists have continued access to regulatory, clinical trial, and public domain information resources to identify relevant regulatory-related news and information, and competitor product regulatory developments and report the most critical findings. + Discuss and triage any technical issues with the reg intel platform, access requests, and distribution issues. + Demonstrate comprehensive understanding of AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize regulatory intelligence information. + Monitor organizational strategic priorities and participate in cross-departmental discussions to consistently capture relevant and targeted regulatory intelligence. + Regularly review and update AI taxonomy terms relevant to Otsuka approved and investigational products, clinical, and business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen and support Otsuka as a learning organization. + Maintain close communication with Informational Technology, Regulatory Technology, and the software vendor to maintain optimal functioning of the regulatory intelligence technology platform. + Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated guidance and regulations. + Lead regulatory public commenting process and posting of Otsuka comments to health authority websites. + Review and update Regulatory Intelligence homepage on GRA Collaboration Portal. + Manage onboarding and offboarding of regulatory intelligence team members, provide input on team member performance, establish annual budget, and manage spend. + Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices. + Review overall quality of ad hoc query research for requested regulatory topics and confirm acceptability of responses. + Demonstrate understanding of the major regional and global industry association priorities (e.g., PhRMA, EFPIA, JPMA, etc.). + Demonstrate solid working knowledge of the drug, biologic, and device development process, laws, regulations, and guidelines from FDA, EMA, PMDA, ICH, etc. + General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products. + Confirm list of upcoming regulatory meetings/workshops/conferences remains current. **Qualifications** + Master's degree in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and Competencies:** + Demonstrates the ability to plan, direct, organize, and coordinate projects. + Demonstrates experience interacting with and supporting senior leadership. + Previous experience with people management and team leadership. + Excellent interpersonal and communication skills, both written and verbal. + Previous experience developing newsletters is desirable. + Results driven and team-oriented collaborative approach required. + Critical thinking and problem-solving skills. + Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook). **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Director, HCP Marketing Lead guides the healthcare provider (HCP) engagement strategy for Centanafadine, a novel launch product for ADHD. This role ensures effective brand positioning, promotional execution, and omnichannel engagement to drive awareness, adoption, and utilization among HCPs. The Director will work cross-functionally with sales, market access, medical affairs, and commercial operations to align on strategic priorities and ensure that HCP marketing initiatives support both short-term brand objectives and long-term market success. This individual will be responsible for developing and implementing innovative programs that generate awareness for a new product in a mature category and must balance both setting the vision and driving to successful execution, along with leading and mentoring commercial team members responsible for HCP personal promotions and PME marketing. **Key Responsibilities** + **HCP Marketing Strategy & Execution:** Develop and execute a comprehensive HCP engagement strategy, ensuring alignment with brandobjectivesand competitive positioning. + **Omnichannel & Non-Personal Promotion (NPP):** Lead the HCP omnichannel strategy, integrating digital, non-personal promotion (NPP), and personal engagement to maximize reach and impact. + **HCP Engagement & Field Enablement:** Develop promotional tools, messaging, and training resources to empower the field sales team andoptimize HCP engagement. + **KOL Engagement & Speaker Programs:** Partner with medical and sales teams toidentifyand engage key opinion leaders (KOLs), oversee speaker programs, and manage congress presence. Develop and execute a comprehensive commercial KOL engagement plan + **Market Insights & Competitive Intelligence:** Utilizemarket research, HCP insights, and competitive analysis to refine strategies and ensure agility in response to market dynamics. + **Brand Positioning & Messaging:** Ensure brand messaging is differentiated, evidence-based, and compelling for target HCP audiences. + **Market Access Pull Through:** Create market access pull through strategies, including but not limited to reimbursement support, patient access programs, and/or formulary positioning, into brand promotional efforts + **Cross-Functional Leadership:** Collaborate closely with medical, regulatory, and commercial operations teams to ensure compliance and seamless execution of promotional initiatives. + **Performance Measurement & Optimization:** Establishand track key performance indicators (KPIs) to assess HCP marketing effectiveness andoptimizepromotional investments. + **Budget & Resource Management:** Oversee marketing budgets, ensuring efficient allocation of resources and maximizing return on investment. **Qualifications & Key Competencies** + Bachelor's degree in Business, Marketing, or a related field; MBA preferred + 10+ years of pharmaceutical marketing experience, with a focus on HCP engagement, omnichannel marketing, or field sales enablement + Experience in CNS, psychiatry, neurology, or related therapeutic areas preferred + Launch experience preferred + Proven ability to develop and execute HCP engagement strategies, including non-personal promotion (NPP), field support, and speaker programs + Omnichannel marketingexpertise, including digital and traditional HCP engagement tactics + Strong analytical skills, with the ability toleveragedata and insights to refine marketing execution + Demonstrated ability to plan and manage large investments and marketing budgets tooptimizeoverall ROI + Excellent collaboration and communication skills, with experience working in cross-functional teams + Experience managing vendors and agency partners, ensuring effective execution of marketing initiatives + Ability to work in a matrixed environment, balancing multiple priorities and aligning stakeholders **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.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

THIS IS A PART-TIME/CASUAL OPPORTUNITY. THE NUMBER OF HOURS PER WEEK WILL VARY. This position is responsible for performing audits of client inventories, storage site inspections and inventory closeouts. J. Knipper and Company and KnippeRx are Equal Opportunity Employers Responsibilities KEY RESPONSIBILITIES: Conduct audits of client inventories at client specified storage site. Follow client business rules, finalize necessary reconciliation(s), and complete required documentation. Complete all assignments in a professional and timely manner in accordance with Company and Client business rules. Submit all assignment status changes using the on-line Audit Inventory Management System (AIMS). Review all instructions and forms required to complete assignments prior to audit to ensure quality service levels. Ensure that assignments are scheduled in accordance within Client expectations and timelines Communicate with client representatives and AIMS management team via email, US mail, and/or phone. *The above duties are meant to be representative of the position and not all-inclusive. Other Responsibilities: Ability to utilize smartphone to update AIMS and complete assignments. Follow all department and company policies and procedures. Strive to exceed client needs. Communicate clearly and professionally in email and phone calls. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Diploma or GED Required College Degree Preferred Must have mobile electronic device. Must have transportation to audit sites. If driving a motor vehicle, must have valid driver's license with records that satisfy Company standards as well as current motor vehicle insurance. Related Experience: Pharmaceutical industry and/ or Pharmaceutical Sales experience preferred. Knowledge, Skills, and Abilities: Strong communication skills, intermediate math skills, attention to detail, and computer skills Physical Requirements: May be required to bend, squat, kneel, or stand for long periods. May be required to lift up to 25 lbs. periodically Reasonable accommodations may be made to enable individuals with disabilities to perform the essential responsibilities of this job.

The Director, Customer Engagement Platforms (CEP) will be responsible for overseeing the development, implementation, and optimization of customer engagement platforms, starting with, but not limited to, Otsuka's Medical Affairs Disease State Engagement platforms (PsychU, PsychUsim, ADPKDsim, and NephU). Reporting to the Sr. Director for Engagement and insights Excellence, the Director will manage the Customer Engagement Platform Team, collaborate with cross-functional groups, drive innovation, and ensure our communities' success. Additionally, this role will keep up to date and provide recommendations on engagement tactics and tools to drive future activities. This position requires a deep understanding of customer engagement strategies and tactics, knowledge on engagement platforms and tools, and the ability align our platform initiatives to corporate, above brand and medical strategies. This successful candidate will need strong project management skills, proficiency in team management and team building, and the ability to effectively collaborate cross-functionally to provide high-quality educational resources paired with the best-in-class delivery mechanism needed for today's healthcare professionals, caregivers, and patients. Key Responsibilities Include: + **Strategy Execution** : Execute the overarching customer engagement strategy on current and future engagement platforms, aligning medical/business objectives. + **Platform Management** : Lead the management and optimization of customer engagement platforms, including marketing automation and analytics tools. + **Team Management** : Lead a high-performing team of operational specialists, including webinar production, medical writing, and customer service engagement specialists. + **Data-Driven Insights** : Utilize data analytics and insights to continuously improve engagement strategies and measure performance against KPIs. + **Technology Integration** : Stay updated on the latest customer engagement technologies and trends, identifying opportunities for implementation. + **Budget Management:** Manage the budget for customer engagement initiatives, ensuring cost-effective solutions. + **Continuous Improvement:** Stay informed about the latest developments in disease research and medical education. Seek feedback from users and stakeholders to identify areas for improvement. Implement enhancements and updates to meet evolving educational needs and align with future Omnichannel initiatives. **Qualifications:** + BS or BA in Marketing, Communication, Information Technology, or a related field required. + Advanced degree or equivalent experience (at least 8 years' experience in pharmaceutical or related industry consulting experience) preferred. + Preferred experience managing website communities or pharmaceutical educational programs. + Experience with social media and web analytics (e.g., Google analytics) preferred. + Proven track record of at least 7-10 years in customer engagement, corporate communications, or related roles, using various engagement platforms. + Strong leadership and team management skills. + Proficiency in customer engagement platforms and tools. + Exceptional analytical and problem-solving abilities. + Excellent communication and interpersonal skills. + Strategic thinker with a results-oriented mindset. + Experience working in remote or hybrid teams is a plus **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $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.

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.

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

The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global quality processes** across the organization. This role ensures that product quality systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize and enhance processes related to **product quality complaints, deviations, CAPA, and management reporting** , ensuring timely and effective resolution and robust compliance. **Key Responsibilities** + Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for: + Product Quality Complaints + Corrective and Preventive Actions (CAPA) + Deviations + Management Reporting and Trending + Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards. + Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates. + Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation. + Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies. + Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making. + Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence. **Qualifications** Required **Required Qualifications:** + Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred. + Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role. + Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820). + Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes. + Strong analytical and problem-solving skills with a data-driven mindset. + Excellent communication, leadership, and stakeholder management skills. + Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools. + Ability to travel internationally as needed. Preferred + Basic understanding of artificial intelligence and advanced analytics + Experience supporting risk management programs or frameworks. + Familiarity with quality management systems and digital tools. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $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.

The Director, External Expert Strategy & Engagement is a critical role responsible for defining, standardizing, and overseeing the company's global strategy for engaging a broad spectrum of external stakeholders. This includes Key Opinion Leaders (KOLs), Digital Opinion Leaders (DOLs), Payers/Access Stakeholders, Academic/Integrated Health Systems, Patients/Caregivers, and Patient Advocacy Groups. The role is accountable for establishing the governance, process clarity, and technological infrastructure necessary to ensure coordinated, high-value, and non-transactional interactions across all functional areas, distinguishing tactics based on the asset lifecycle stage (Early vs. In-line). This position reports directly to the Executive Director of External Engagement and Field Excellence. **** **Key Responsibilities:** **Strategic Governance and Accountability** + Establish clear accountability and process ownership for all external expert engagement activities, defining roles and responsibilities across the Medical Affairs (GMA) function to address the current pain point of limited clarity on accountabilities and responsibilities. + Develop and implement a standardized global strategy for external engagement that distinctly tailors objectives based on asset lifecycle (e.g., Early Asset engagement must focus on obtaining input from KOLs and Payers on trial design and clinical/economic value). **System and Data Management** + Coordinate with stakeholder engagement liaisons (from GMA, Commercial, Clinical Development, Market Access, Patient Advocacy and Stakeholder Management, Corporate Communications, and Government Affairs) and IT to migrate multiple, overlapping stakeholder lists. + Drive process adherence for the consistent upkeep and governance of the centralized external stakeholder list, ensuring the database accurately tracks engagement across all categories of stakeholders (e.g., Patients/Caregivers, Academic Systems, Digital Opinion Leaders). + Champion the use of the centralized system to track all medical expert interactions, contact attempts, and strategic insights captured. **Coordination and Best Practices** + Facilitate connections between the designated primary stakeholder lead contact and any internal team member seeking subsequent outreach to prevent multiple concurrent communications and requests. + Encourage and mandate best practices for GMA preparation before any stakeholder outreach, ensuring all engagement is high-quality and strategically aligned. + Partner with the Training team to develop standardized training and resources for internal teams on proper engagement protocols, compliance guidelines, and use of the centralized Veeva system, highlighting the specific goals for engaging each stakeholder group. + Collaborate with Global Training Lead to coordinate any needed training on external engagement processes and/or capabilities. + Consider technology and AI to support workflow improvement. **Qualifications:** **Education and Experience:** + Advanced scientific or clinical degree is required (PharmD, MD, PhD, or equivalent). + Minimum of 8 - 10 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 5 years in Global Medical Affairs, Strategic Operations, or an equivalent function focused on External Expert/KOL Engagement. + Proven experience in designing, implementing, and managing global engagement processes across multiple therapeutic areas and across different asset lifecycle stages. + Demonstrated success in leading a complex cross-functional project (e.g., system migration, process standardization) involving IT and multiple business units. **Skills and Competencies:** + Exceptional ability to drive process governance and change management across a global matrix organization. + Superior Stakeholder Management and influencing skills, capable of gaining consensus and driving compliance among diverse functional leaders (Commercial, Clinical, Global Medical Affairs). + Strong technological acumen with proven experience working with Veeva or similar management platforms for centralized data management. + Excellent communication and presentation skills, with the ability to articulate the strategic value of coordinated external engagement to senior executive leadership. + Motivated and solution-oriented, with a clear focus on simplifying complex processes for end-users. **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.

The Senior Manager, External Engagement Strategic Planning will play a critical role in shaping and executing strategic initiatives that enhance the impact of Medical Affairs external stakeholder engagement activities (including those of the managed market liaison (MML) team). This role will lead cross-functional planning efforts, develop frameworks for scientific exchange and stakeholder engagement, while ensuring alignment with global and US medical strategies and business objectives. **** **Key Responsibilities Include:** **Strategic Planning & Execution** + Lead the development and implementation of strategic plans for external engagement across therapeutic areas + Collaborate with global and US Medical Affairs teams to ensure alignment with scientific and commercial priorities + Offer strategic planning support, analytics tools, and guidance on process excellence techniques for External Engagement & Field Excellence, as well as MML teams + Drive the development of annual and long-range strategic plans for the MML team, including goal setting, performance metrics, and resource planning with Strategic Planning Lead oversight + Drive the integration of insights from field medical teams into strategic planning processes **External Engagement Strategy** + Design and optimize engagement models for key external stakeholders including healthcare professionals (HCPs), scientific experts, and advocacy groups + Develop metrics and KPIs to assess the effectiveness of external engagement activities. + Partner with Compliance and Legal to ensure all engagement strategies meet regulatory and ethical standards. **Cross-Functional Collaboration** + Work close with Medical Excellence and Operations team to facilitate cross-functional workshops and planning sessions to align on stakeholder engagement priorities **Operational Excellence** + Oversee the development of tools, resources, and training programs to support MML effectiveness and strategic engagement + Contribute to the development of governance models and operational processes that support compliant and coordinated external engagement + Lead initiatives to improve data capture, insight generation, and reporting from field medical teams and MML team + Manage budgets and timelines for strategic planning initiatives + Prepare executive-level presentations, dashboards, and reports to communicate progress, insights, and recommendations to senior leadership **Qualifications** **Education and Experience:** + Bachelors degree required, advanced degree in life sciences (PharmD, PhD, MD, or equivalent) preferred + 7+ years of experience in Medical Affairs, Field Medical, Market Access, or related functions within the pharmaceutical or biotech industry **Skills and Competencies:** + Ability to work effectively within cross-functional teams and in an environment of rapid change + Proven experience in strategic planning, field medical operations, or external stakeholder engagement + Strong understanding of compliance and regulatory requirements in medical engagement + Strong understanding of the U.S. & Global healthcare landscape, including payer and policy environments + Excellent communication, leadership, and project management skills + Strong understanding of pharmaceutical compliance and regulatory frameworks + 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 + Experience with digital engagement platforms and data analytics tools + Familiarity with global medical affairs operations and regional nuances + Strategic mindset with a passion for innovation and continuous improvement **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.