Senior Manager jobs at U.S. Pharmacopeia

**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work-an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. **Brief Job Overview** The Case Management Program Manager at the United States Pharmacopeia (USP) is responsible for managing the monograph production planning process, ensuring the efficient tracking, monitoring, and reporting of monograph production progress against established plans. This role involves coordinating cross-functional teams, implementing process improvements, and ensuring timely execution of monograph development in alignment with USP's strategic objectives. The Program Manager will develop robust case management workflows to track issues, mitigate risks, and support continuous improvement efforts. **How will YOU create impact here at USP?** In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments. The Case Management Program Manager has the following responsibilities: - Monograph Production Planning & Execution: o Develop and maintain the monograph production plan, ensuring alignment with USP's priorities, Program Unit Teams' needs, & Publication schedules. o Collaborate with Program Unit Teams, Publication Team, Finance, and Executive stakeholders to establish realistic production plan, production timelines, and resource allocation for monograph development. o Identify and escalate potential bottlenecks or challenges in monograph production to ensure timely resolution. - Tracking, Monitoring & Reporting: o Establish and oversee processes for tracking and monitoring monograph production against the approved plan. o Generate regular reports and dashboards to provide leadership with visibility into monograph development progress, challenges, and trends. o Develop performance metrics and key indicators to assess the efficiency of the monograph development pipeline. - Case Management & Issue Resolution: o Collaborate with Software Development Team to rapidly resolve case issues escalated by Program Unit Teams that impact adhere to production plan. o Support the effective prioritization of enhancement requests for Case Management System o Drive/Support Case Management System enhancement to improve efficiency and quality of monograph production. - Stakeholder Engagement & Process Improvement: o Act as the primary liaison between Program Unit Teams, Publication Team, Finance, and Executive stakeholders to ensure transparency in monograph production. o Identify opportunities for process improvement and recommend strategies to enhance efficiency, quality, and effectiveness in monograph development o Support training efforts and develop resources to enhance stakeholder understanding of monograph planning and case management processes. **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: Education: - Bachelor's degree required, preferably in life sciences, public health, or a related field. Experience: - Minimum of 5-7 years of experience in program management, scientific operations, or manufacturing operations. - Proven experience applying Lean methodologies (e.g., tiered accountability, value stream mapping, problem-solving frameworks) in a scientific / transactional setting. - Strong track record of developing and executing production plans, tracking performance metrics, and driving process improvements. Skills & Competencies: - Strong project management skills, including experience with production planning, issue tracking, and process improvement. - Expertise in Lean tools and principles (e.g., A3 problem-solving, 5 Whys, Kaizen, PDCA cycles). - Excellent analytical and data interpretation skills to track performance and recommend improvements. - Strong interpersonal and communication skills to engage cross-functional teams and external stakeholders. - Proficiency in project tracking software. Proficiency in case management system is preferred. - Ability to manage multiple priorities in a fast-paced, mission-driven environment. **Additional Desired Preferences** Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration. **Supervisory Responsibilities** No, this is an individual contributor role. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Salary Range: USD $83,500.00 - $106,250.00 annually. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Project Management **Job Type** Full-Time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **About BioLife Plasma Services** BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Limited, is an industry leader in the collection of high-quality plasma, which is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can't be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 250+ state-of-the-art plasma donation centers across the United States. Our employees are dedicated to enhancing the quality of life for patients and ensuring that the donation process is safe, straightforward, and rewarding for donors who wish to make a positive impact. When you work at BioLife, you'll feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. This position is currently classified as "virtual/remote" in accordance with Takeda's Hybrid and Remote Work policy. **_OBJECTIVES/PURPOSE_** The BioLife Forecasting, Pricing & Analytics (FPA) team within the Plasma-Derived Therapies (PDT) business unit at Takeda is seeking a Senior Manager of Pricing Strategy & Analytics. This role is critical for the FPA team, as it combines technical expertise with strategic insights to inform pricing decision-making for BioLife's U.S. plasma collection network. This role will lead the data analysis, process automation, implementation, and optimization of pricing strategies to drive volume growth and improve cost efficiency. This individual will partner with cross-functional teams (Operations and IT) to execute large-scale pricing experiments, deliver actionable insights, and ensure alignment with BioLife's long-term growth strategy. This role reports to the Associate Director - Pricing and Business AI Lead at BioLife. **_ACCOUNTABILITIES_** - **Pricing Strategy & Optimization** - Build a robust process to improve efficiency in creating weekly business insights. - Lead automation and execution of pricing experiments (e.g., optimization, cross-center tests). - Translate business objectives into fee strategies that balance KPI performance. - Drive adoption of advanced pricing methodologies (hierarchical models, A/B testing, time-series forecasting). **- Analytics & Forecasting** - Manage end-to-end pricing analytics, including business metrics. - Partner with data science teams to refine models (Supervised Learning, Time Series, Neural Network, etc.). **- Cross-functional Leadership** - Collaborate with senior leaders to shape pricing decisions and weekly fee plans - Translate complex analytical outcomes into clear recommendations for executives. - Support governance with transparent business rules, documentation, and communication to stakeholders. **- Team & Project Management** - Lead and mentor analysts in pricing, forecasting, and business intelligence. - Manage multiple pricing initiatives simultaneously, balancing tactical execution with strategic vision. - Drive standardization and automation of reporting across pricing KPIs. **_DIMENSIONS AND ASPECTS_** + **Technical expertise** : Proven hands-on experience with PySpark, Python, SQL, and BI tools (Power BI or Tableau), with advanced Excel skills for rapid analysis. + **Analytical leadership** : Demonstrated ability to proactively identify new opportunities, design models/experiments, and deliver insights that drive measurable business improvements. + **Agile execution** : Thrives in ambiguity and fast-changing environments, with the ability to pivot quickly and still deliver clarity. + **Clear communication** : Ability to distill complex technical findings into clear business narratives. **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_** **Required** + Bachelor's degree in Economics, Statistics, Computer Science, Engineering, Data Science, or a quantitative field required; Master's preferred + 9+ years in analytics, data science, pricing, strategy, consulting, and/or forecasting with demonstrated impact. + Strong foundation in statistics and experimentation - hypothesis testing, regression, causal inference, experimental design, and power calculations. **Preferred** + Extensive expertise in data science, revenue management, and experimental design. + Strong stakeholder management and executive communication skills. + Ability to work across highly matrixed, global organizations. + Familiarity with the plasma/healthcare industry or subscription-based pricing is a plus. + Comfort with ambiguity and ability to translate complex data into actionable strategies. **Who You Are** + A critical thinker who thrives on solving ambiguous problems through rigorous analysis and experimentation. + Data-driven, with a passion for uncovering trends, root causes, and actionable insights. + Business-minded, able to partner effectively with leadership and product owners to shape strategic decisions. + Adaptable and proactive, thriving in a fast-paced, high-visibility environment with competing priorities. **_ADDITIONAL INFORMATION_** + Domestic travel required (up to 10%). **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** USA - IL - Bannockburn - Virtual **U.S. Base Salary Range:** $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - IL - Bannockburn - VirtualMassachusetts - Virtual **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** Yes

Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Senior Manager for the Public Affairs team to support its strategic communications, advocacy, and research efforts related to the cost of prescription drugs, including insurer and PBM practices, the 340B program, and other related issues. This individual will collaborate across functions with internal teams-including federal and state advocacy, policy, legal, and research-as well as external consultants and partners. The Senior Manager will be a vital part of the Public Affairs team and will play a key role in guiding PhRMA's messaging, audience engagement, and campaign execution for the proactive policy agenda. The Sr. Manager will: Develop and support public affairs campaigns focused on 340B and PBM issues, coordinating with internal teams and external stakeholders. Draft and edit various public-facing materials, including talking points, press releases, op-eds, blogs, fact sheets, and presentations. Translate complex policy and research findings into accessible messaging for targeted audiences. Coordinate audience segmentation and engagement strategies, including message testing and paid media efforts. Support the development of communications strategies for federal and state advocacy priorities. Monitor and analyze media coverage, public discourse, and political dynamics to inform proactive and reactive communications. Contribute to producing and tracking campaign deliverables, reports, and dashboards. Work with the Research & Policy departments to identify and leverage data and reports for storytelling. Act as a liaison with external consultants, vendors, and member companies on campaign execution. Track and help analyze public opinion research work that supports PhRMA policy. Perform other duties as assigned. Professional Experience / Requirements 4+ years of experience in public affairs, communications, political campaigns, health policy, or issue advocacy. Experience working in public affairs firms, campaigns, associations, or advocacy organizations. Demonstrated ability to synthesize complex issues into clear, strategic messaging. Experience with research and data analytics as inputs to communication strategy. Proficiency in written and visual communication tools (e.g., Microsoft Office, PowerPoint). A bachelor's degree in public affairs, communications, political science, public health, or a related field is preferred. Preferred Experience / Requirements Understanding of 340B, PBMs, and the U.S. drug pricing and coverage landscape. Experience working on or supporting messaging for healthcare-related litigation, legislative efforts, or political advocacy. Knowledge of political segmentation tools and media monitoring platforms. Familiarity with audience analysis, message testing, and data-driven campaign design. Key Success Factors PhRMA seeks a curious, campaign-minded, mission-driven individual passionate about improving access to innovative medicines and addressing the complex dynamics shaping U.S. health care. The successful candidate will thrive in a fast-paced environment, be eager to learn, and bring both analytical rigor and creative energy to their work. They will have strong writing and messaging skills, comfort with ambiguity, and an ability to collaborate across functions. The ability to distill policy, research, and data analytics into compelling stories for varied audiences is essential. Potential Salary Sr. Manager: $92,100 - $126,600 per annum. Salary is commensurate with experience and other compensable factors. Who we are The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading innovative biopharmaceutical research companies, which are laser focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. Over the last decade, PhRMA member companies have invested more than $850 billion in the search for new treatments and cures over the last decade, supporting nearly five million jobs in the United States. Connect with PhRMA For information on how innovative medicines save lives, please visit: ************* ****************** *********** ********************** ********************* What we offer In addition to a highly competitive salary and bonus program, various opportunities for reward and recognition and a platform of extensive benefits, PhRMA is committed to the development and overall wellbeing of our team members. We offer traditional (medical, dental, vision, flexible spending, life, AD&D, LTD, STD, LTC) and enhanced benefits such as parental leave, a well-being program, an on-site fitness facility, back-up care, health advocate service, an employee assistance program, and commuting benefits. We also offer a robust 401k plan with employer contributions upon the first day of hire and immediate vesting, a generous paid time off plan, ten paid holidays (plus inauguration day), half day Fridays preceding holidays, half day Fridays in the summer months, and a paid winter break. As an organization, we work together in the office on Mondays through Thursdays and remotely on Fridays. We also work remotely in August. We are committed to the growth and development of our team members and offer many learning opportunities, including an integrated onboarding program, best-in-class leadership programming, tuition reimbursement, industry on-site and off-site training, and other management/professional development programs. Corporate social responsibility is also important to us at PhRMA. Our team members participate in community service activities, fundraising drives and charitable athletic events. We are committed to supporting our family of professionals at PhRMA and strive to create programs that help our team members manage the challenges of balancing a fast-paced career with their personal goals. Equal Opportunity Employer PhRMA provides equal employment opportunities to all applicants without regard to race, color, religion, national origin, sex, age, marital status, personal appearance, sexual orientation, gender identity or expression, family responsibilities, genetic information, disability, matriculation, political affiliation or veteran status in accordance with applicable federal, state and local laws governing nondiscrimination in employment. The job description contains an overview of the activities and duties for this role. Responsibilities may change, and new ones may be assigned at any time.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Senior Manager, Clinical Data Management, will be responsible for all clinical data management activities and deliverables for the assigned study/studies in accordance with ICH/Good Clinical Practices (GCP), GDCMP and other relevant regulations, procedures and guidelines. The responsibilities of this position include but are not limited to vendor service oversight, vendor invoice verification, budget contract negotiations and management, being the subject matter of expert of data management to provide guidance and suggestions to vendor and the study team for all data management deliverables and timelines from study start-up through study close-out, final reporting, and data archiving. The Senior Manager will be involved in development of SOP(s), data standards and standardization, managing and leading the ongoing practices in DM processes with internal study resources and/or vendors for the responsible study/studies and driving for DM operation excellence. The Senior Manager will also partner with other functional groups and external vendors to ensure timelines and the quality of data deliverables of the responsible study/studies. Essential Job Functions and Responsibilities: These may include but are not limited to: Manages the assigned study/studies and makes expert recommendations and/or decisions that assure timelines, deliverables and data quality. Collaborates cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process. Resolves and/or escalates issues encountered at the study level and ensures the performance of the data management function. Provides effective CRO/vendor oversight to ensure requirements are met and the project plans are executed to meet the development needs. Leverages data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders. Contributes to team building and best practice to achieve the defined data quality with cost efficiency. Participates in regulatory audit and/or company initiatives. Education and Experience: Required: MS/BS in life sciences or related field 7 + years of direct data management experience and at least 3 years of CRO oversight experiences In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry. Strong project management skills and experiences working with CROs/vendors Demonstrated organizational and interpersonal skills. Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting. Highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance Knowledge of GCP, ICH and other regional regulations and compliance Experiences with clinical data lifecycle from database set-up and maintenance to database lock and archiving Working knowledge of current technologies in clinical trial data collection systems. Preferred: Knowledge in current data collection technologies and integration (EDC, eCOA, CTMS, Drug Safety Database Systems, IRT). Competence in Excel and/or SAS programming is a big plus Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $149,000 - $185,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The Senior Manager, Reimbursement Access will play a critical role in ensuring appropriate patient access to Xeris products by leading the Reimbursement Access team, shaping national access strategies, and supporting operational excellence across the function. The incumbent must have deep experience in reimbursement, patient access, and healthcare provider support services, and leadership experience that includes driving the execution of complex operations while developing a high performing team of Reimbursement Access Managers. Responsibilities Team Leadership & Talent Development Identify, recruit, onboard, and develop a high-performing team of Reimbursement Access Managers (RAMs) across key geographies. Provide coaching, mentorship, and performance management to drive effectiveness and professional growth. Lead field-based access teams to execute patient support strategies that improve access and affordability for patients. Reimbursement Strategy & Execution Collaborate with Patient Access leadership to design and implement innovative reimbursement access strategies that align with product and company goals. Analyze access barriers and develop field-based solutions to improve access to therapies for rare disease patients. Partner with internal teams (Commercial, Medical Affairs, Legal, Compliance) to ensure alignment and seamless execution of access initiatives. Operational Excellence Assist in developing standard operating procedures (SOPs), metrics, and reporting tools to evaluate and optimize the effectiveness of the Reimbursement Access function. Drive continuous improvement initiatives to ensure the highest standards of patient access and compliance. Monitor and assess reimbursement trends, payer coverage, and changes in access environment; provide recommendations to senior leadership. Stakeholder Engagement Serve as a strategic liaison between internal stakeholders and field reimbursement teams to ensure market and patient needs are addressed. Provide insights from the field to inform leadership decisions on payer strategy, patient affordability programs, and other access-related initiatives. Represent the company at relevant industry meetings, conferences, and with key external stakeholders as needed. Qualifications Bachelor's degree in business, healthcare, or related field (advanced degree preferred). Minimum of 7 years of experience in market access, reimbursement, patient services, or related pharmaceutical roles. Prior leadership experience managing field reimbursement teams strongly preferred. In-depth understanding of the reimbursement landscape including buy-and-bill, specialty pharmacy, payer dynamics, copay assistance, and HUB services. Experience in rare diseases or specialty biologics/therapies. Demonstrated ability to lead cross-functional initiatives in a fast-paced, entrepreneurial environment. Willingness to travel (up to 30%) to support field teams and stakeholders. Competencies: Leadership, Presentation skills, Written and Verbal Communications, Analytical skills, Problem Solving, Teamwork & Collaboration, Customer Service focus, Adaptability, Professionalism A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Ability to Travel up to 30%. Travel may include air and ground travel to HCP locations, and company meetings The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-REMOTE As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $130,000 to $220,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Senior Manager, Patient Access is responsible for managing the operational plans for all patient services tactics to support the Xeris product portfolio. This leadership role is responsible for assigned Xeris patient support responsibilities inclusive of reimbursement, financial, patient assistance, patient advocacy management and adherence support. The incumbent will manage daily operations of a team of field-based Patient Access Managers across geographically aligned regions. Responsibilities Manage patient services programs for Xeris products. Collaborate cross functionally to ensure successful implementation and long-term success of Patient Services' strategy and operations by understanding patient journey and best in class services required for excellence across reimbursement, financial support, patient advocacy and adherence. Embrace continuous improvement initiatives and innovative program enhancements throughout the program lifecycle. Proactively cultivate collaborative and productive relationships with a wide range of teams, including Marketing, Sales, Market Access, Legal, and Compliance to discuss service design and develop action plans for execution, in a constantly changing environment. Drive project management and execution for cross-functional Patient Services Projects. Act as a consistent liaison, point of contact and facilitator to enable appropriate discussions and projects between Patient Services, Brands, Training, IT, Commercial Operations, and other business partners and departments related to Patient Services' operational activities. Develop Patient Services CRM expertise; coordinate with IT and train internal and external end users. Serve as the Patient Services Lead in working with IT on the development of patient services systems, system upgrades, and reporting platform. Collaborate with Operations to monitor operational metrics and routinely monitor to identify changes in patterns. Coordinate with all applicable stakeholders, implement improvements and share best practices within patient services and across business units. Oversight and management of team performance to meet defined objectives. Provide strong people management to attract, coach and retain team of impactful and engaged Patient Access Managers. Create an environment of continuous learning where team members feel challenged and engaged. Foster team effectiveness within matrix team by sharing knowledge, experience, and information. Establish and/or further develop and continuously strengthen advocacy relationships with national and community organizations through compliant and thoughtful engagement in alignment with company business priorities and objectives. Identify opportunities for patients and patient advocates to participate in development of educational materials, review clinical study protocols and other documents and programs (e.g., informed consent, patient, and product services, etc.) Establish and help operationalize best practices for communicating with patients who reach out to Xeris proactively via phone, email, etc. in collaboration with personnel responsible for medical information. Communicate key learnings from the patient community to inform cross-functional (i.e. medical, clinical, and commercial) team strategies. Qualifications Bachelor's Degree in business administration, management, marketing, or equivalent experience preferred. A minimum of 7 years of experience in the pharmaceutical/healthcare environment, in roles involving patient advocacy, reimbursement, and marketing/sales, including previous patient access management experience. Ability to exhibit agility in an evolving environment. Decision support experience. Demonstrated knowledge of and ability to comply with HIPAA guidelines. Strong track record of driving results in a complex internal and external environment A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position. Competencies: Project Management, Relationship Management, Collaborative Team Leadership, Change Agility, Authentic Leadership, Talent Developer, Attention to Details, Presentation skills, Written and Verbal Communication skills Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a remote position and requires travel up to 25%. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-REMOTE As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $180,000 to $200,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Job Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit ******************* or follow MMS on LinkedIn. Responsibilities: Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client. Demonstrated ability to lead/ manage multiple individuals and/or groups. Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target. Strategically assesses resource utilization and forecasting to ensure companywide goals are met Effectively communicates complex strategic concepts with ability to tailor message to targeted audience. Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose. Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment. Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance. Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans. Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input. Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams. Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration. Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals. Requirements: Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred. Minimum of 6 years' experience in clinical trial transparency, disclosure, or medical writing role At least 5 years of experience in a CRO environment. Demonstrated managerial skills and experience preferred. High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines. Excellent scientific writing skills. Excellent analytical, organizational, and problem-solving skills. Proficiency with MS Office applications. Strong communication and presentation skills. Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements Understanding of CROs and scientific & clinical data/ terminology, & the drug development process. Powered by JazzHR HVP5j87vGf

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **About BioLife Plasma Services** BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Limited, is an industry leader in the collection of high-quality plasma, which is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can't be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 250+ state-of-the-art plasma donation centers across the United States. Our employees are dedicated to enhancing the quality of life for patients and ensuring that the donation process is safe, straightforward, and rewarding for donors who wish to make a positive impact. When you work at BioLife, you'll feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. This position is currently classified as "virtual/remote" in accordance with Takeda's Hybrid and Remote Work policy. **_OBJECTIVES/PURPOSE_** The BioLife Forecasting, Pricing & Analytics (FPA) team within the Plasma-Derived Therapies (PDT) business unit at Takeda is seeking a Senior Manager of Pricing Strategy & Analytics. This role is critical for the FPA team, as it combines technical expertise with strategic insights to inform pricing decision-making for BioLife's U.S. plasma collection network. This role will lead the data analysis, process automation, implementation, and optimization of pricing strategies to drive volume growth and improve cost efficiency. This individual will partner with cross-functional teams (Operations and IT) to execute large-scale pricing experiments, deliver actionable insights, and ensure alignment with BioLife's long-term growth strategy. This role reports to the Associate Director - Pricing and Business AI Lead at BioLife. **_ACCOUNTABILITIES_** - **Pricing Strategy & Optimization** - Build a robust process to improve efficiency in creating weekly business insights. - Lead automation and execution of pricing experiments (e.g., optimization, cross-center tests). - Translate business objectives into fee strategies that balance KPI performance. - Drive adoption of advanced pricing methodologies (hierarchical models, A/B testing, time-series forecasting). **- Analytics & Forecasting** - Manage end-to-end pricing analytics, including business metrics. - Partner with data science teams to refine models (Supervised Learning, Time Series, Neural Network, etc.). **- Cross-functional Leadership** - Collaborate with senior leaders to shape pricing decisions and weekly fee plans - Translate complex analytical outcomes into clear recommendations for executives. - Support governance with transparent business rules, documentation, and communication to stakeholders. **- Team & Project Management** - Lead and mentor analysts in pricing, forecasting, and business intelligence. - Manage multiple pricing initiatives simultaneously, balancing tactical execution with strategic vision. - Drive standardization and automation of reporting across pricing KPIs. **_DIMENSIONS AND ASPECTS_** + **Technical expertise** : Proven hands-on experience with PySpark, Python, SQL, and BI tools (Power BI or Tableau), with advanced Excel skills for rapid analysis. + **Analytical leadership** : Demonstrated ability to proactively identify new opportunities, design models/experiments, and deliver insights that drive measurable business improvements. + **Agile execution** : Thrives in ambiguity and fast-changing environments, with the ability to pivot quickly and still deliver clarity. + **Clear communication** : Ability to distill complex technical findings into clear business narratives. **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_** **Required** + Bachelor's degree in Economics, Statistics, Computer Science, Engineering, Data Science, or a quantitative field required; Master's preferred + 9+ years in analytics, data science, pricing, strategy, consulting, and/or forecasting with demonstrated impact. + Strong foundation in statistics and experimentation - hypothesis testing, regression, causal inference, experimental design, and power calculations. **Preferred** + Extensive expertise in data science, revenue management, and experimental design. + Strong stakeholder management and executive communication skills. + Ability to work across highly matrixed, global organizations. + Familiarity with the plasma/healthcare industry or subscription-based pricing is a plus. + Comfort with ambiguity and ability to translate complex data into actionable strategies. **Who You Are** + A critical thinker who thrives on solving ambiguous problems through rigorous analysis and experimentation. + Data-driven, with a passion for uncovering trends, root causes, and actionable insights. + Business-minded, able to partner effectively with leadership and product owners to shape strategic decisions. + Adaptable and proactive, thriving in a fast-paced, high-visibility environment with competing priorities. **_ADDITIONAL INFORMATION_** + Domestic travel required (up to 10%). **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** USA - IL - Bannockburn - Virtual **U.S. Base Salary Range:** $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - IL - Bannockburn - VirtualMassachusetts - Virtual **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** Yes

Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Information Technology Department does at Worldwide The IT department is made up of seasoned professionals united in one common goal: to keep Worldwide's technical infrastructure operating at the highest levels for our employees and our customers. We are a global team comprised of numerous professionals including cyber security, artificial intelligence, IT helpdesk, application support, and more. What you will do Develop, implement, and oversee functional Application management plans for the portfolio of systems. Manage and document application, system, and performance controls in line with industry best practices. Manage application operations activities and staff; monitor, review, investigate, and escalate system support events in technical areas relating to application performance. Develop, implement, and maintain functional metrics such as KPIs and QTLs, inclusive of Uptime, System/Capability Utilization. Form partnerships with Business Owners and IT Infrastructure to ensure Enterprise class support is given to these business-critical systems. Partner with Computer Systems Validation and Technical Delivery to ensure that validation and regulatory documentation is completed to ensure compliance with GxP standards. Work with Worldwide business clients to document business requirements for projects and applications interfaced with it. Lead Data Governance across team ensuring appropriate rigor and discipline is present across data integration, mastering, and management for all systems within the clinical portfolio. Perform system configuration and functional testing ensuring it meets requirements and specifications. Partner with Technical Delivery to Write and review validation scripts and user acceptance testing for new workflows and processes. Provides technical expertise and training to teammates and business users. Work with project teams and users to resolve or escalate technical issues. Estimate and plan implementation activities. Work with software vendors to understand and support existing and future functionality. Co-ordinate system Disaster Recovery (DR) testing as required. Write, review, and update Standard Operating Procedures, Work Instructions and Business Guidelines for both IT technicians and end users What you will bring to the role Strong planning and scheduling skills. Excellent written and verbal communication skills. Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment. Ability to exercise sound judgment and make decisions independently. Must be self-motivated and able to work with minimal supervision. Able to succeed and contribute to a team environment. Proficiency in MS-Office and cloud-based systems and applications. General Knowledge in HIPAA, data privacy and security, GxP, and FDA regulations governing validated applications, 21CFR Part 11 and ICH E6 (R2) Good Clinical Practice. A proven track record in setting expectations, providing feedback, and guiding professional growth ensures both organizational goals and individual aspirations are achieved. Your experience Bachelor's degree preferably in a technical discipline. Minimum of 8 years' experience managing application performance, health, and availability or equivalent experience. Demonstrated expertise in people leadership includes inspiring, coaching, and developing diverse teams, while effectively managing team dynamics, resolving conflicts, and recognizing individual strengths for optimal performance. Familiar with databases like Oracle or SQL Server. Knowledge of Quality Assurance functions. Experience in the pharma, CRO, or other health-related industry. We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit ***************** or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

Paradigm is rebuilding the clinical research ecosystem by enabling equitable access to trials for all patients. Our platform enhances trial efficiency and reduces the barriers to participation for healthcare providers. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm's seamless infrastructure implemented at healthcare provider organizations, will bring potentially life-saving therapies to patients faster. Our team hails from a broad range of disciplines and is committed to the company's mission to create equitable access to clinical trials for any patient, anywhere. Join us, and bring your expertise, passion, creativity, and drive as we work together to realize this mission. The Senior Manager of Clinical Data Management (CDM) is a senior leader within Paradigm's data organization, responsible for overseeing the execution, quality, and operational excellence of data management activities across Phase IV, post-marketing, and real-world evidence (RWE) studies. Reporting to the Head of Clinical Data Management, this leader plays a key role in shaping data delivery strategy, driving cross-functional collaboration, and ensuring consistent, high-quality outcomes across a growing portfolio. This position requires strong technical expertise, exceptional leadership capability, and the ability to operate strategically while maintaining hands-on oversight of complex data workflows. What You'll Do: Leadership & Team Development: Lead, mentor, and develop a high-performing team of Clinical Data Managers and CDM operations staff. Oversee workload allocation, staffing plans, competency development, and performance management. Foster a culture of excellence, continuous improvement, and accountability within the CDM function. Portfolio Oversight & Data Delivery Excellence: Provide senior oversight of end-to-end CDM activities across multiple studies, including database development, CRF design, edit check specification, cleaning and reconciliation workflows, and database lock. Ensure predictable delivery of data management milestones through proactive oversight of timelines, metrics, and quality indicators. Anticipate operational risks and lead resolution efforts in collaboration with cross-functional partners. Cross-Functional Partnership: Collaborate closely with Clinical Operations, Biostatistics, Safety, Regulatory, Quality, Product, and Engineering to ensure integrated and efficient data delivery. Serve as a senior CDM representative in cross-functional study meetings, troubleshooting sessions, and strategic planning discussions. Align CDM workflows with broader study goals and portfolio-level priorities. Process Improvement & Operational Innovation: Lead the development, refinement, and adoption of CDM SOPs, templates, libraries, and operational playbooks. Drive initiatives to streamline workflows, strengthen data quality controls, and enhance scalability across the CDM organization. Support digital transformation initiatives, including automation, modern EDC capabilities, and advanced data review tools. Sponsor Engagement & Delivery Management: Serve as a senior CDM point of contact for sponsors, ensuring transparent communication, timely delivery, and trusted partnership. Provide proactive updates, risk assessments, and strategic recommendations to internal and sponsor stakeholders. Contribute to proposal development, data strategy discussions, and operational feasibility assessments for new and ongoing programs. Who You Are: 8-12 years of clinical data management experience, with substantial experience leading complex studies or multi-study portfolios. Proven leadership experience managing data teams and driving high-quality delivery in fast-paced environments. Deep expertise in EDC systems, CDISC standards, data cleaning and reconciliation processes, and regulatory requirements (ICH-GCP, 21 CFR Part 11, GDPR). Strong communication skills with the ability to influence, collaborate, and lead across diverse technical and operational teams. Highly organized, analytical, and committed to data integrity, operational excellence, and continuous improvement. Able to operate strategically while remaining hands-on with complex problem-solving when needed. What You'll Receive: Paradigm Health offers a comprehensive Total Rewards package to support your well-being and success, including: Competitive health, dental, and vision insurance Mental health support for you and your family through Spring Health Equity package Unlimited paid time off (PTO) 16 weeks of paid parental leave Flexible work options - remote and hybrid arrangements Company-paid life insurance Company-paid short-term and long-term disability coverage One Medical membership 401(k) plan with company match At Paradigm, we are committed to providing equal employment opportunities to all qualified individuals. We encourage and welcome candidates from all backgrounds and perspectives to apply for our open positions. We are interested in all qualified individuals and ensure that all employment decisions are based on job-related factors such as skills, experience, and qualifications.

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit ******************* or follow MMS on LinkedIn. Responsibilities: Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client. Demonstrated ability to lead/ manage multiple individuals and/or groups. Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target. Strategically assesses resource utilization and forecasting to ensure companywide goals are met Effectively communicates complex strategic concepts with ability to tailor message to targeted audience. Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose. Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment. Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance. Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans. Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input. Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams. Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration. Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals. Requirements: Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred. Minimum of 6 years' experience in clinical trial transparency, disclosure, or medical writing role At least 5 years of experience in a CRO environment. Demonstrated managerial skills and experience preferred. High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines. Excellent scientific writing skills. Excellent analytical, organizational, and problem-solving skills. Proficiency with MS Office applications. Strong communication and presentation skills. Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements Understanding of CROs and scientific & clinical data/ terminology, & the drug development process.

Job Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit ******************* or follow MMS on LinkedIn. Responsibilities: Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client. Demonstrated ability to lead/ manage multiple individuals and/or groups. Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target. Strategically assesses resource utilization and forecasting to ensure companywide goals are met Effectively communicates complex strategic concepts with ability to tailor message to targeted audience. Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose. Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment. Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance. Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans. Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input. Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams. Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration. Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals. Requirements: Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred. Minimum of 6 years' experience in clinical trial transparency, disclosure, or medical writing role At least 5 years of experience in a CRO environment. Demonstrated managerial skills and experience preferred. High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines. Excellent scientific writing skills. Excellent analytical, organizational, and problem-solving skills. Proficiency with MS Office applications. Strong communication and presentation skills. Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements Understanding of CROs and scientific & clinical data/ terminology, & the drug development process. Powered by JazzHR cTExMoQFX9

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit ******************* or follow MMS on LinkedIn. Responsibilities: * Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client. * Demonstrated ability to lead/ manage multiple individuals and/or groups. * Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target. * Strategically assesses resource utilization and forecasting to ensure companywide goals are met * Effectively communicates complex strategic concepts with ability to tailor message to targeted audience. * Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose. * Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment. * Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance. * Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans. * Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input. * Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams. * Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration. * Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals. Requirements: * Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred. * Minimum of 6 years' experience in clinical trial transparency, disclosure, or medical writing role * At least 5 years of experience in a CRO environment. * Demonstrated managerial skills and experience preferred. * High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines. * Excellent scientific writing skills. * Excellent analytical, organizational, and problem-solving skills. * Proficiency with MS Office applications. * Strong communication and presentation skills. * Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements * Understanding of CROs and scientific & clinical data/ terminology, & the drug development process.

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.

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products. - Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines. - Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines. - Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities. - Serves as the sponsor point of contact to the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues. - Effectively manages and directs internal support staff and external consultants for assigned projects. - Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions. - Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output. - Assess and develop innovative ideas to move GRA department to address current and future challenges. **K** **nowledge, Skills, and Competencies** **K** **nowledge** - Experience working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong oral and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. - Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed. - Able to establish close communications and working relationship with cross functional teams to meet business objectives. Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow. - Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies Chart (Level X) **P** **hysical Demands and Work Environment** Travel (approximately 20%) See document Physical Demands and Work environment for further requirements. **Education and Related Experience** Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products. - Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines. - Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines. - Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities. - Serves as the sponsor point of contact to the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues. - Effectively manages and directs internal support staff and external consultants for assigned projects. - Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions. - Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output. - Assess and develop innovative ideas to move GRA department to address current and future challenges. **K** **nowledge, Skills, and Competencies** **K** **nowledge** - Experience working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong oral and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. - Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed. - Able to establish close communications and working relationship with cross functional teams to meet business objectives. Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow. - Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies Chart (Level X) **P** **hysical Demands and Work Environment** Travel (approximately 20%) See document Physical Demands and Work environment for further requirements. **Education and Related Experience** Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel. **** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products. + Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes. + Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. + Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus. + Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. + Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. + Performs other duties as assigned related to CMC RA function. **Qualifications** **Education** : + BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products. + Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications will be a plus. **Skills:** + Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues. + Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval. + Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. + Comprehensive understanding of the global regulatory environment. + Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. + Strong leadership, communication, and negotiation skills. + Ability to manage complex projects and timelines across multiple regions. + Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + CMC reviewer (assessor) with FDA or EMA will be a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Director, Congress and Medical Education Strategy & Execution is responsible for developing and leading the global medical strategy and tactical execution for congresses and medical education, spearheading Otsuka's non-promotional scientific communication initiatives across the diverse Nephrology and Immunology portfolio. This role drives scientific engagement through impactful congress strategies & execution educational programs, and evidence-based content that support Otsuka's mission to improve patient outcomes through deep scientific understanding and collaborative partnerships. The Director partners closely with global and regional cross-functional stakeholders - including Global Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I) and Commercial, to ensure scientific alignment, operational excellence and consistency in Otsuka's external scientific exchange. **** **Key Responsibilities Include:** **Congress Strategy and Execution** + Lead development and execution of comprehensive multi-year medical congress strategy for Nephrology and Immunology aligned with Otsuka's pipeline and product lifecycle stages , including prioritization of key international and regional congresses, scientific communication objectives, symposia, booth presence, and internal/external engagement activities + Collaborate with Medical Strategy, Medical Communications, Field Medical and Medical Information to develop high-quality, scientifically rigorous presentation and materials; ensuring data dissemination plans are timely, consistent, and strategically aligned + Drive scientific communication planning across global and regional teams to ensure consistent, data-driven communication objectives across congress activities + Partner with Medical Communications to orchestrate Otsuka's scientific presence at congresses, including: + Abstract submissions and poster presentations + Oral presentations and late-breaking sessions + Sponsored symposia and educational sessions + Medical booth design and operations + Press activities and medica engagement + Develop and execute strategies for engaging external experts and stakeholders (e.g. (e.g. KOLs, Patient Advocacy Groups) before during and after congresses + Organize and facilitate investigator meetings and advisory boards in conjunction with congress + Coordinate opportunities for scientific exchange between Otsuka Medical Affairs personnel and external experts and stakeholders + Lead all aspects of congress planning activities and post-congress insight generation to maximize impact and inform future strategies + Implement innovative digital strategies to extend congress reach and engagement, including virtual and hybrid congress solutions + Establish KPIs for congress activities and implement systems to track and analyze performance + Conduct post-congress analysis toa assess impact and identify areas for improvement **Independent Medical Education (IME)** + Develop and implement the global medical education strategy for the relevant therapeutic area in alignment with medical and objectives and strategy + Oversee the development of scientific exchange platforms, independent medical education (IME) initiatives to elevate disease and product knowledge globally + Partner with regional and local teams to ensure educational programs address unmet needs and comply with regional regulations and global standards + Identify, evaluate, and partner with external experts, medical societies and educational providers to ensure high-quality, unbiased scientific content delivery + Monitor educational impact through KPIs, metrics and insights **Cross-Functional Collaboration** + Serve as the strategic lead and subject matter expert for the relevant therapeutical area medical education and congress activities + Collaborate with Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Regulatory, and Commercial teams to ensure scientific alignment and appropriate integration of new evidence into educational content + Provide leadership and mentorship to team members and vendors to ensure high standards of scientific integrity, external experts and stakeholder (e.g., KOL) experience and operational excellence + Create and manage congress budgets, ensuring cost-effectiveness and ROI and ensure compliant use of medical education and congress funding + Represent Global Medical Affairs in governance forums and cross-functional planning meetings + Ensure all congress and medical education activities comply with global and local regulatory requirements, Otsuka policies, data publication embargos and industry codes + Proactively identify and mitigate risks related to scientific exchange and external engagements based on Global Medical Affairs policies and SOPs + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) preferred + Additional business or communications training (MBA, MPH, etc.) preferred + 12+ years of experience in Medical Affairs and ~5 years focused on experience leading global congress strategy, IME programs, or scientific engagement; experience in Nephrology, Immunology, or related therapeutic areas is preferred + Proven track record of successful congress planning and implementation on a global scale including implementation of digital and virtual congress solutions + Proven success managing matrixed & cross-functional global teams and external vendors + In-depth understanding of industry compliance, regulatory frameworks, and ethical considerations for scientific engagement **Skills and Competencies:** + Strategic and analytical thinker with the ability to translate complex science for a variety of audiences and anticipate trends and shape proactive congress and educational strategies + Excellent project management, communication (written and verbal), and stakeholder engagement skills + Collaborative and communicative, with ability excel at building and maintaining relationships with external stakeholders and experts (e.g. KOLs, scientific) + Financial acumen and experience managing large program budget + Ability to influence across matrixed teams and drive strategic initiatives **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 Director, Value & Access Strategy leads the strategy and tactical development supporting our market access customers. This encompasses corporate approach recommendations for existing and emerging channels, bridging pipeline market access strategies to inline, Therapeutic Area initiatives and is accountable for all brand payer related initiatives for the portfolio working closely with the brand teams. **** + Develop and lead a cross-portfolio approach to market access customers + Develop an CNS wide portfolio value proposition for market access customers + Lead the team to develop and implement payer pull-through material + Lead the team to develop and refine the payer value proposition for inline brands + Collaborate with Commercial team to ensure payer value drivers are incorporated into all payer marketing initiatives + Continually evaluate Market Access strategies for pipeline products by partnering with Medical Affairs, Value and Evidence and the Market Access team while effectively bridging them to inline marketing support + Direct Brand specific Payer/Advocacy Market research activities with CSI colleagues + Manage Payer Marketing budget resources + Lead market access channel assessments and build recommendations on the best way to approach our existing channels + Lead the assessment and development of new channel enhancement + Manage key Agencies of Record to deliver tools and tactics + Engage, inform and influence key stakeholders + Collaborate closely with brand marketing teams + Engage with Regional Senior Business Directors as the business dictates + Contributes to the development of direct report + Travel expected up to 20% **Qualifications** Required: + Bachelor of Arts (BA) or Bachelor of Science (BS) degree from an accredited four-year college or university (or the equivalent if education obtained outside of the United States) + 10+ years pharmaceutical experience in sales or marketing with at least 6+ years of market access responsibilities and successful track record + Solid track record of driving market access initiatives within an organization + Strong interpersonal skills and ability to work effectively in a matrix team environment + Excellent planning and strategy development while executing against tight timelines + High emotional intelligence in managing multiple business initiatives and cross-functional relationships + Strong communication skills, both verbal and written + Strong organizational and project management skills Preferred: + MBA or master's degree preferred + Knowledge of payer and access stakeholder needs in the US preferred **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.