Senior Manager jobs at Alexion Pharmaceuticals - 922 jobs

The Director of Access Strategy for Dupixent Rhinology Allergy and Gastroenterology leads the development and execution of market access strategies, focusing on payer engagement, pricing, contracting, and value communication for specialty pharmaceutical products. This role requires collaboration across multiple teams to optimize access and commercial performance while supporting budget management and vendor coordination. The position demands deep expertise in specialty pharmaceuticals, payer dynamics, HEOR, and strategic market execution within the US healthcare landscape. Job Title: Director, Access Strategy - Dupixent Rhinology Allergy and Gastroenterology Location: Cambridge, MA, Morristown, NJ About the Job This role is responsible for supporting market access strategy and execution for Dupixent Rhinology Allergy and Gastroenterology (RGA) franchise, specifically CRSwNP, EoE & pipeline indications. This role is instrumental in executing upon and integrating payer tactics aligned with franchise strategy, life cycle management, the pricing & contracting approach across payer channels and ensuring customer-facing teams are appropriately trained and resourced on current and future strategies for Dupixent franchise. The role will require working collaboratively and autonomously with the Dupixent Access Strategy teams, working cross-functionally to manage the performance of the payer channels, including accountability for tracking and improving targeted account performance, key account prioritization, and development of marketing strategies and tactics that will optimize business. This role requires working closely with all groups within the broader US Market Access organization to ensure the goal of profitable access. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: Oversee strategic and tactical execution for the Dupixent Access Strategy team for CRSwNP, EoE & RGA pipeline indications, and integration of payer marketing tactics into brand business and alliance management Support and oversee relevant Dupixent payer brand budget for therapeutic area project work Support strategic and tactical execution for the Dupixent Value & Access team and integration of payer marketing tactics into brand business and alliance management Collaborate with the brand therapeutic areas and provide input into brand strategy and tactical development for Dupixent indications, serving as expert for the payer, distributor and channel perspective and ensuring economic considerations are incorporated Assess the need to implement an unbranded and branded payer media plan supporting the Dupixent strategic plan, as applicable Partner with HEVA business partners to inform real world evidence generation and ensure health economic activities are in place to meet the needs of payers while demonstrating value across the Dupixent franchise Execute on market access strategies and plans, including the brands' value story, and help to integrate tactics into the overall brand plan Identify gaps in current market access understanding and develop plans to gain direct payer insights through primary research, advisory boards, etc., and work with vendors to implement projects in a timely, impactful manner Develop strong value communication platform and messaging to support access targets and goals Uncover pull through & push-through opportunities and advise on execution of pull & push-through strategies for all channels and geographies based upon formulary position and opportunity Manage vendors/agencies, including the development of RFPs, review, selection and milestones achievement towards contract deliverables About You Qualifications: Professional Skills and Competencies: Experience in payer/brand marketing Experience in working with US payers Strong leadership skills and demonstrated ability to lead cross functionally Deep understanding and experience the specialty space including pricing, distribution and payer dynamics unique to specialty products Demonstrated experience in launching new products Demonstrated experience in working in specialty pharmacy Understanding of Commercial, Medicare Part D and Medicaid Experience identifying trends and insights assimilating into market/channel strategy Understanding of key payer value drivers and ability to develop and implement payer value propositions Understanding of macro-US Healthcare trends and their translation/impact on future Dupixent business Understanding of HEOR drivers and ability to coordinate payer insights to inform the RWE plan Working understanding of strategic pricing and commercial contracting strategy, process and rules Demonstrated ability to identify and develop business opportunities based upon the above Deep understanding of the cross functional interactions between Account Management and Field Sales to ensure successful implementation of pull through plan Strong financial acumen, analytic skills & critical thinking ability Understanding of the legal/regulatory environment and internal Sanofi legal/regulatory guidelines and processes Ability to communicate at the executive level Ability and willingness to embrace technology to accelerate efficiencies Education: • B.A. or B.S. Degree; Advanced Degree preferred Experience: • Minimum 6-10 years of business experience in the pharmaceutical healthcare sector • 5-7years in payer space (account management, payer marketing, contracting, public policy etc...) Travel: Approximately 20% Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. Keywords: market access strategy, payer engagement, specialty pharmaceuticals, pricing and contracting, health economics outcomes research, commercial strategy, pharmaceutical market access, value communication, dupixent, payer marketing

A pioneering biotechnology firm in Boston, MA, is seeking a Director of Vector Engineering to oversee the discovery strategy for novel lentiviral vectors. The ideal candidate will have over 8 years of experience in gene therapy R&D, strong leadership skills, and a proven track record in optimizing viral vectors. This dynamic role involves collaborating across teams and managing projects that have a tangible impact on patient outcomes, all within a supportive and innovative environment. #J-18808-Ljbffr

Director, Market Access Strategy (Heme) page is loaded## Director, Market Access Strategy (Heme)locations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27384**Job Description**Vertex currently operates at the forefront of rare disease scientific innovation and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF), Sickle Cell Disease, Transfusion-Dependent Beta Thalassemia and Pain. In addition to clinical development programs in these commercialized areas, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases including programs in Type 1 diabetes, IgA Nephropathy (IgAN), APOL-1 Mediated Kidney Disease, and Duchenne Muscular Dystrophy, among others.The **Director,** **Market Access Strategy (Heme)** is accountable for leading, overseeing, and project managing the development of Market Access (MA) strategies, primarily the payer value proposition (PVP) resources and associated materials and trainings, tactical support programs and overall execution of access resources across all channels for the commercialization of CASGEVY. This role requires a significant degree of collaboration, leadership, influencing and driving strategic alignment across multiple functions (Account Management, Trade, Pricing & Contracting, US Public Affairs, HEOR, Global Value & Access Strategy (GVAS), and Marketing). This role will report into the Sr Director, Market Access Strategy, Heme.* Provide **critical leadership** and project management in developing and implementing **brand and market access strategies** by channel, to support patient access and customer reimbursement for CASGEVY via the creation and delivery of impactful market access resources to identified and prioritized accounts. This includes leadership with CRC submissions, reviews and responses.* Strong ability to **wholistically evaluate** Market Access Landscape, continue to generate **insights** to inform **strategy and execution*** Drive payer strategy including understanding of pricing, contracting, payer landscape, access & reimbursement to ensure all strategies and tactics are well thought through and aligned to overarching brand strategy* Refinement and execution of the market access strategy across Payer and Trade* Lead initiatives to understand, analyze and demonstrate clinical, economic, and societal value to payers, decision-makers, and influencers based on FDAMA114 guidelines (aka Pre-approval Information Exchanges) as well as payer value proposition* Develop, train, and implement the necessary promotional resources and reimbursement pull-through that support field account teams' efforts with key customers* Plan and execute payer Advisory Boards* Customize strategies based on Commercial, Medicaid & Medicare demographics, legislation, & trends* Maintain a strong understanding of the CASGEVY patient journey, billing and coding requirements and be a strong partner to the Market Access Strategy lead for the Access and Reimbursement field team.* Maintain a strong understanding of CASGEVY Trade policy and decisions, and work hand in hand with the trade strategy partners and trade account team to support our trade partners for an efficient and effective patient journey* Identify and address key product barriers to payer access and performance by applying advanced payer analytics and market trends* Primary point of contact overseeing agency and external vendors to deliver resources and strategic insights on time and within budget* Developing KPIs and metrics to assess impact of key initiatives* Act as trusted, subject matter expert on US market access landscape to internal colleagues and external customers**Knowledge and Skills:*** Expert knowledge of US healthcare system, including gov't & commercial payers (Medicaid experience preferred), policy, and regulatory environment* Strong experience working with National and Regional payer account teams aligning on **policy language, and operationalization of payer processes*** Strong understanding of the **hospital setting**, billing and coding requirements for therapies as well as the flow of funds coupled with **cell & gene experience*** Previous contract strategy leadership experience in the pharmaceutical/biotech or healthcare industry* Experience in developing and articulating a clear and pragmatic value proposition* Proven track record of meeting or exceeding objectives & goals, both as an individual and as part of a team* **Excellent communication skills** with experience presenting to customers and internal leadership* Demonstrated ability to **successfully lead cross-functional teams,** influencing without direct authority, with the interpersonal skills to foster collaboration and succeed in a highly matrixed environment* Ability to perform in a ***fast-paced environment***, manage multiple priorities simultaneously, and work effectively across cross-functional teams**Education and Experience:*** Bachelor's degree in relevant field. MBA or Advanced degree preferred* Typically requires 10+ years of MA experience or the equivalent combination of education and experience**Location**: HQ on a hybrid schedule (3 days a week)**Pay Range:**$201,200 - $301,800**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com #J-18808-Ljbffr

A leading biotechnology company is seeking a Director of Market Access Strategy focused on Heme. This role involves developing market access strategies, collaborating across teams for effective payer solutions, and ensuring reimbursement for CASGEVY. Candidates should have over 10 years of experience in Market Access and a strong understanding of the US healthcare landscape, with excellent project management skills. The position is hybrid, allowing for flexible remote work. #J-18808-Ljbffr

**Job Description**Vertex is growing at a rapid pace with challenging and exciting opportunities for motivated professionals who are keen to contribute to the Vertex mission to invest in scientific innovation to create transformative medicines for people with serious diseases. Our robust and complex R&D pipeline requires a focus on efficiency and prioritization as we scale. The Vertex finance function is integral to achieving our company's strategic goals, providing critical insights and analysis in support of decision-making across the organization. We are investing in our ability to provide data-driven insights by organizing and automating financial data and processes to enable our growing global scale. We are also leveraging best practices to strengthen our business partnering and decision support capabilities. By joining our function, you will become part of a fast-moving, forward-thinking team to support the ongoing growth of a leader in the biotechnology industry.**General Summary:**The Senior Director, Global Development FP&A is a seasoned finance leader who partners directly with our Global Clinical Development (early- and late-stage programs) organizations and cross-functional program teams to run global financial planning, forecasting, and strategic analysis. Reporting to the VP of R&D Finance, this highly visible role serves as a strategic advisor to the Chief Medical Officer's organization and senior leadership, influencing portfolio prioritization and investment decisions through financial insights. The ideal candidate brings deep expertise in clinical trial finance, executive presence, and a proven ability to drive business outcomes in a dynamic, science-driven environment.This role is for you if you possess strong decision support analytical skills, project management expertise, team management skills, and demonstrated ability to collaborate with cross-functional teams to drive innovation and deliver successful product development outcomes.**Key Duties and Responsibilities:**A key leader in financial planning and analysis within our function, your responsibilities entail:Advanced Scenario Planning and Risk Analysis:* Build, maintain, and own clinical program-level budgets (Phase 1 to Phase 3), clinical trial cost models, and forecasts; produce cost-to-complete and cost per patient analysis used in strategic decisions.* Lead advanced scenario modeling for clinical programs, including sensitivity analyses on timelines, enrollment rates, and regulatory milestones to inform go/no-go decisions.* Translate clinical development plans into financial implications and ROI-based recommendations.Strategic Influence and Business Partnership:* Participate in cross-functional program teams and governance committees, providing real-time financial guidance.* Deliver program dashboards, KPIs and trend analyses for executive and portfolio reviews.* Prepare and present executive-level updates.Team Leadership:* Lead and develop a team of 6-8 clinical finance professionals: set team priorities, establish processes, and build scalable operating mechanisms for financial support* Drive automation and digital transformation of clinical finance processes, leveraging tools like Hyperion, Oracle, and emerging analytics platforms to improve accuracy and scalability* Mentor staff on forecast accuracy, stakeholder management and financial modeling best practices* Drive a collaborative, service-oriented culture between finance and Global Clinical Development organizations Governance and Compliance Leadership:* Oversee month-end and quarter-end close activities related to clinical expense (accruals, reconciliations, GL review).* Ensure accurate, timely accruals for CROs, FSPs, sites, labs and other clinical vendors. Maintain audit-ready documentation for clinical program spend* Improve transparency and accountability around clinical opex and resource allocation through clear processes, benchmarks and metrics**Basic Requirements:*** Bachelor's degree in finance, Accounting, or related field; MBA or CPA/CFA strongly preferred.* 12+ years of progressive FP&A experience, with at least 5 years in the pharmaceutical or biotech industry.* Experience supporting R&D or Clinical Development functions at a global scale.* Strong understanding of R&D processes, portfolio management, and project evaluation methodologies.* Proven ability to manage complex budgets, forecasts, and analyses in a dynamic, fast-paced environment.* Excellent communication and presentation skills, with the ability to influence stakeholders at all levels and a proven ability to present complex financial insights to senior stakeholders.**Important Knowledge and Skills:*** Deep understanding of pharmaceutical industry dynamics and executive-level business partnering.* Hands-on exposure to clinical operations and/or CRO/FSP budgeting.* Strong analytical capabilities in portfolio analysis.* Proficiency in Microsoft Office and financial systems, including Hyperion and Oracle.* Proven ability to lead change in complex, cross-cultural matrix environments.* Exceptional communication and influencing skills across senior leadership and cross-functional teams.* Ability to apply broad market knowledge to drive financial performance and strategic outcomes.* Strategic thinker with attention to detail.#LI-DB1#HYBRID**Pay Range:**$212,000 - $318,000**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com #J-18808-Ljbffr

Greater Philadelphia or Boston (on-site 3 days a week) A rapidly growing, Specialty Pharmaceutical company with a recent successful launch is seeking a Patient Services Analytics leader as a crucial addition to their Commercial Operations team. This individual will own the analytics strategy and execution for Patient Services, partnering closely with Trade, Reimbursement managers, Market Access, and Sales teams. This high visibility position will drive the creation of standardized KPIs and dashboards, integrate specialty pharmacy data, and deliver insights that enhance speed ‑ to ‑ approval, conversion, adherence, and the overall patient experience. Responsibilities: Set the analytics strategy and roadmap for Patient Services, aligning standardized KPIs and definitions to business priorities and streamlining how insights are shared with stakeholders. Oversee KPI and dashboard governance from intake and design through validation, deployment, change control, and access-ensuring consistency across field teams, hubs, vendors, and digital partners. Lead patient‑journey and program performance analytics to measure throughput, cycle times, conversion, adherence, and abandonment; identify bottlenecks and recommend targeted interventions. Drive advanced analytics, data integration, and cross‑functional leadership by developing predictive models, defining BI/data requirements. Managing vendor/offshore resources, and translating insights into clear executive‑level narratives while maintaining compliance with Legal/Privacy. Qualifications: Bachelor's degree required, advanced degrees are preferred. 8+ Years in within the pharmaceutical industry, focusing on Patient Services/HUB Analytics. Expertise in HUB & Specialty Pharmacy Data, case manager/reimbursement workflows, and exposure to specialty distribution data. Fluency in Python, SQL, and hands-on experience with PowerBI/Tableau (demonstrating dashboard ownership and training). Proven ability to lead teams, communicate technical data with stakeholders and cross functional departments, and manage external vendors. Note: Applicants who do not meet the above requirements will not be considered for this role.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Purpose: Lead, coordinate and facilitate strategic development, tactical implementation and financial planning components of all Sales and Marketing related topics of the Brand Strategy and manage customer and other commercial activities including leading and coaching Sales Force to maximize brand sales and margin placing the patient at the center of any efforts and operating within AbbVie business code of conduct, policies and all applicable laws and regulations. Qualifications Effectively manage and execute all marketing and sales related (Eye Care - Dry Eye Disease portfolio) activities as per franchise Plan, such as development and implementation of commercial Brand strategy, tactical Brand activities execution and deliver sales performance to maximize or exceed brand sales targets. Liaise with relevant countries leads functions to integrate local insights into brand strategy planning, strategy execution and to facilitate the development and alignment of franchise vision and strategic objectives. Lead product launches, plan and roll out promotional activities, and coordinate the placement of POS materials and merchandising displays. Support product market expansion through innovative commercial programs. Develops view on Brand issues and competitive positioning, customer segments and their needs, and market development Build and maintain strong relationships with key accounts (wholesalers, retail chains, non-traditional medicine vendors, optometry traders), understanding their business drivers and aligning solutions to their needs. Develop and execute innovative market expansion programs and digital marketing initiatives-including multi‑channel strategies, strategic partnerships (both traditional and non-traditional), and targeted campaigns to drive franchise brand objectives and maximize reach. This includes designing and implementing digital marketing tactics and multi‑stakeholder collaborations tailored to support brand growth and engagement. Coordinate cross‑functional activities (with sales, supply chain, finance, regulatory) for seamless execution and brand alignment. Develop tailored engagement plans, negotiate commercial terms, and secure new product listings to ensure optimal market access and in‑store excellence. Support preparation of franchise financial planning (Financial Plan, Focus/Update, Long Range Plan). Professionally manage and build cross functional cooperation between key stakeholders. Ensure timely and qualitative market intelligence information for brand strategy/tactical communication from Brand Teams to In‑Field Teams to optimize brand strategy and its execution. Effectively Execute Distributor Governance Process. Ensuring engaging and managing sub‑distributors onboarding selection consistent with the Distributor Governance Framework, processes and compliance controls. As Brand Team Leader Through a combination of data and real‑world insights, lead strategic discussions with the cross‑functional task force Team to identify opportunities for the brand. Lead the task force Team around a brand vision and objectives that are shared by all members. Ensure task force Team Members contribute to the development of the Brand strategy through the Brand Planning process in line with strategy defined by Global Brand Team (where applicable) and ensure adequate involvement of multiple functions as relevant for the Brand objectives. Continuously encourage task force Team members' collaboration and foster team spirit. Take accountability and responsibility for Task force Team activities and processes. Additional Information Qualifications Bachelor's degree or equivalent. Relevant experience with proven track record of success in marketing and sales management within FMCG /pharmaceutical/Eyecare industry in Sub‑Sahara Africa on multiple brands and within multiple team constellations. Result‑oriented, pay attention to detail, accurate, agile and able to meet deadlines. Ability to translate strategies into actionable and realistic marketing actions. Solid knowledge of strategic and tactical marketing principles and techniques including digital knowledge and proven track record of strategic and operational execution. Must possess the ability to be a fast learner, be creative, flexible with good negotiation skills and ability to effectively work in a team. Experience in leading, motivating and co‑ordinating cross‑functional teams. Experience in business development case formulation and product launches. Solid working knowledge of healthcare, FMCG environment and evolving landscape with a proven sales track record of success. Excellent written and verbal communication skills, including effective presentation skills. Ability to communicate objectives and results to a variety of audience. Solid knowledge of finance principles and processes, analytical and decision‑making skills. Experience in FMCG (Fast Moving Consumer Goods) and pharmacy. Experience in Digital Marketing. Personal Qualities Ability to set Brand vision and strategy while maintaining balance between opportunities, resources and investments to maximize growth for a whole portfolio. Ability to effectively translate the vision and broad strategies into concrete/actionable strategic plans and goals, followed by execution of plans. Ability to drive for results and translate strategy into flawless execution. Ability to negotiate with people from other functions and Affiliate Management Team to secure required resources and budget for Brand activities. Ability to prioritize decisions and activities, and make difficult decisions to ensure efficient use of resources and address critical issues impacting the brands. Ability to anticipate, adopt, execute and adjust where relevant. Ability to establish clear expectations, provide timely, accurate feedback - both positive and negative - and take appropriate follow‑up action to build capability and ensure effective functioning. Ability to encourage open exchange of ideas and knowledge. Ability to build organization and inspire people by continuously putting things in perspective and communicating the bigger picture. Ability to recognize, reward and promote team accomplishments. Ability to promote collaboration and remove obstacles to teamwork across the organization. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* #J-18808-Ljbffr

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. Job Description Purpose Provide leadership for the capital planning and strategy development aspects of the Global Engineering function. This includes leading the development of ongoing capital investment strategy for the global manufacturing network (IME) and oversight of the capital planning processes for all AbbVie operations. Lead engineering Front End Planning (FEP) activities in support of network strategy development including asset utilization modeling, capital cost estimation, business development deal input, pipeline technology assessment and network scenario development. Provides leadership for and ownership of all capital planning processes within Operations supporting the major financial cycles (Long Range Planning, Annual Plan, Update) to ensure optimal use of Operations capital. Provide recommendations to IME senior leadership on investments to optimize the manufacturing network footprint while maintaining assurance of supply and geographic balance. Remain abreast of emerging technologies and the state of the industry to inform network LRP strategy. Establish and maintain appropriate relationships with external engineering, architectural and peer organizations to facilitate benchmarking and incorporation of best practices into Global Engineering business processes. Provide project management, direction and oversight to the Global Engineering Programs department. Coordinate facility and utility projects to ensure adherence to AbbVie standards and specifications. Develop resource plans for approved projects and make recommendations regarding use of internal or external resources for project/facility planning, design and execution. Manage and leverage common engineering systems. Responsibilities Lead experienced team of project engineers in scenario development and capital cost estimation for projects ranging from $1MM - $200MM. Accountable for all processes, policies and procedures related to capital planning. Responsible for Operations-wide capital planning processes for all financial cycles (LRP, Plan, Update) with an annual investment spend of >$400MM. Responsible for asset utilization modeling and development of multi‑year investment strategies for a global network of 27 manufacturing sites. Conduct and record benchmarking of capital cost estimation best practices within AbbVie and professional associations, A&E firms and other peer companies. Lead and coordinate objective criticality scoring of site‑level projects to deliver network‑wide investment prioritization. Establish and maintain relationships with senior Operations functional leaders (QA, Central Services, S&T, BTS, etc.) to support development of functional capital plans and provide engineering support. Interface with sites (leadership and engineering) to assemble and maintain a library of capability and capacity information to inform investment decisions and strategy. Build partnership with S&T/R&D to ensure network technology preparedness to support the pipeline and influence key decisions early in the product development lifecycle. Qualifications Bachelor's Degree in Engineering. Master's Degree in Management or an MBA preferred. 10‑15 years of experience in Engineering and/or Manufacturing Management. Key Stakeholders SVP, Internal Manufacturing and Engineering; Regional VPs Manufacturing; VP, Global Engineering Additional Information The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short‑term incentive programs. AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. Equal Employment Opportunity US & Puerto Rico only - to learn more, visit ************************************************************************* Reasonable Accommodation US & Puerto Rico applicants seeking a reasonable accommodation can learn more at ************************************************************* #J-18808-Ljbffr

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. Covers CA, WA, OR, NV, and ID including: Los Angeles, CA: San Diego, CA; San Jose, CA; San Francisco, CA; Seattle, WA; Spokane, WA; Portland, OR; Las Vegas, NV; Coeur d'Alene, ID. 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. Direct Employers Posting: Los Angeles, CA: Seattle, WA; Portland, OR; Las Vegas, NV; Coeur d'Alene, ID.

Job Title: Director of Leadership Excellence and Customer-Facing Skills About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. Sanofi has currently the best and most robust pipeline of R&D and consequent new launches of our history. As new phase of Play-To-Win strategy, funding this pipeline and new launches is key to materialize the miracles of the science to improve people lives. Thus, as we enter the next phase, modernization of Sanofi is required as per the recent announcements on DRIVE, and in this respect, we are in the beginning stages of organizing the Go-to-Market Capabilities (GTMC) team at global level. The GTMC organization will help us to drive best-in-class capabilities across the board and bring value and excellence in our commercial operations. This move is a key part of the aimed modernization of Sanofi and will allow us to focus on our priorities across our products, market and pipeline through the reallocation of resources and realizing the efficiencies of removing silos that exist between our business units, avoiding the duplication and overlapping of resources, standardizing our processes and tools, operating with a One Sanofi approach to accelerate our key capabilities development, and fostering the entrepreneurial spirit by speeding up the decision making. Our Team: The Director of Leadership Excellence & Customer-Facing Skills reports to the Head of Field Learning and Development and manages a team that develops, and implements leadership development, customer-facing skills, and strategic account management solutions across General Medicines, Vaccines and Specialty Care. This position will work closely with Senior Field leadership, People & Culture, Field Learning and Development peers, and Global Commercial Training colleagues to understand the needs and gaps to be addressed to ensure that the customer-facing organization, both leaders and individual contributors, are equipped with the skills and competencies to drive the success of our business. Critical to this role is providing harmonized solutions, while considering necessary customization at the therapeutic and functional level; all in a compliant manner. This position requires a strong background in leadership, customer facing skills, strategic account management, project management, adult learning, training, and strategic thinking. The selected candidate will be responsible for delivering solutions to address known behavioral and skill-based issues to drive performance and business results for both the leaders and members of customer-facing teams. The ideal candidate should also possess a strong bias towards enterprise leadership, needs-based design and development, proactivity, clear communication and tendency towards optimizing solutions, both in quality and efficiency. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: As a leadership team member of the Customer Facing Capabilities/Commercial Training organization, the Director of Leadership Excellence & Customer-Facing Skills will be accountable to: Leading the Leadership Excellence & Customer-Facing Skills team with a focus on developing the skills, behaviors, and mindset of customer-facing personnel, both leaders and individual contributors. Partnering with senior leadership to identify, prioritize and execute skill development for their respective customer-facing teams, aligned to the business's strategic imperatives Prioritizing training needs in order to build, revise and implement curriculum to meet changing market demands for customer-facing leadership and individual contributors. Building alliances and partnerships with Senior Leaders and global/local business partners to increase consistency and capability to align strategy and manage change effectively. Partnering with the Field Learning and Development Leadership team to align skills to business needs. Partnering with TA leadership team to measure and monitor the impact of training on the business and make recommendations for improvement. Collaborating with the broader Customer Facing Capabilities/Commercial Training team for support in execution of the overall customer-facing leadership and individual contributors' curriculum. Collaborating with other Global partners and functions to identify and leverage existing resources and best practices in developing customer-facing leadership and individual contributors within the organization. Assessing external environment to establish benchmarks and to understand and leverage innovative techniques and best practices in developing customer-facing leadership and individual contributors within and outside of Pharma/Biotech industries. Performing other duties as assigned. About You Work Experience: 10+ years of relevant experience in Biotechnology or Pharmaceuticals; Undergraduate degree, MBA preferred, including at least 3 years as a people leader. Demonstrated success in leading national, home-office based training for a minimum of 3 years. Experience leading with & without authority in a matrix environment including global partnerships. Project management with proven delivery of outstanding results. Experience in having deployed innovative learning solutions for large-scale audiences. Experience leading and developing diverse teams across multiple functions; Demonstrated leadership ability to drive change within an organization, cultivating support and maximizing contribution from team members. Knowledge: Strategic analysis and planning Strategic Account Management Project management Impactful Communication (written and oral) Supporting IT platforms for delivery and reinforcement Leadership development topics Customer-facing transversal skills Adult-learning principles. Learning strategy and instructional design, including training methodologies. Performance-based development for key stakeholders and team. Skills and Competencies: Demonstrated ability to think strategically Ability to work in a team environment with collaboration across multiple functional areas. Strong project management skills Ability to develop rapport and credibility with key stakeholders. Strong facilitation skills and executive presence; ability to communicate to all levels of the organization. Ability to leverage networks, to develop people, coach and give feedback, empower people. Ability to lead change while achieving business goals and objectives, act for change, challenging continuously the status quo. Proven track record of strong execution and results. High persistency and resilience. Training experience strongly preferred including needs analysis, training design and development, understanding of adult learning principles and measuring training effectiveness Demonstrated ability to motivate teams, foster collaborative environment, negotiate and influence in a matrix environment, exercise tact and diplomacy in stressful situations Experience of leading a team, working with field sales force and driving talent development of a team Ability to demonstrate appropriate interpersonal styles and techniques and is able to modify one's behavior to gain acceptance of ideas or plans Strong quantitative abilities and experience managing a budget High persistency and resilience. Additional Considerations: Leadership: Leads by example and walks the talk; Role models the principles and behaviors of Play-To-Win and Thoughtful Risk Taking. Engages others through active and impactful communication; Demonstrates a high-level drive, passion and ambition for high performance; Challenges continuously the status quo; Develops fresh approaches in order to deliver results; Has well-developed time management skills, mastering in prioritizing tasks and planning own workloads to ensure deadlines and desired results are met. Networking: Is a strong relationship builder; Seeks out new opportunities; Demonstrates teamworking and shares best practices always; Has experience of successfully leading projects in multicultural environments and in a matrix organization. Personal Characteristics: Hands-on, accountability, creativity, initiative, high persistence and resilience, stress management, learning agility, result orientation, ability to work on one's own, continuous improvement, listening skills, empathy to understand the needs of the different businesses within distinct geographies. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $148,125.00 - $246,875.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

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

Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget. **** - Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs. - Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents. - Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites. - Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs. - Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments. - Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. - Participate in forecasting study expenditures and resourcing needs. - Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. - Provide timely communication of any variances in budget forecast to the Director/Associate Director. - Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. - Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned. - Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency. - Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF. - Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned. - Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities. - Represent Clinical Management in departmental and cross-functional initiatives, as assigned. - Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts. - May have supervisory responsibilities including: + Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes. + Assuring compliance with departmental, SOP, compliance, and corporate training + Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities. + Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance. - Performs other duties, as assigned. **Qualifications/ Required** Knowledge/ Experience and Skills: - Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations. - Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW). - Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management. - Strong understanding of global regulatory requirements. - Strong communication, organization, planning, analytical, problem solving, and people management skills. - Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.) - Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.). - Ability to travel up to 25%. **Educational Qualifications** Required: - Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience. Preferred: - Previous supervisory experience. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget. **** - Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs. - Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents. - Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites. - Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs. - Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments. - Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. - Participate in forecasting study expenditures and resourcing needs. - Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. - Provide timely communication of any variances in budget forecast to the Director/Associate Director. - Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. - Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned. - Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency. - Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF. - Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned. - Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities. - Represent Clinical Management in departmental and cross-functional initiatives, as assigned. - Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts. - May have supervisory responsibilities including: + Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes. + Assuring compliance with departmental, SOP, compliance, and corporate training + Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities. + Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance. - Performs other duties, as assigned. **Qualifications/ Required** Knowledge/ Experience and Skills: - Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations. - Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW). - Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management. - Strong understanding of global regulatory requirements. - Strong communication, organization, planning, analytical, problem solving, and people management skills. - Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.) - Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.). - Ability to travel up to 25%. **Educational Qualifications** Required: - Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience. Preferred: - Previous supervisory experience. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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

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

Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget. **** - Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs. - Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents. - Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites. - Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs. - Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments. - Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. - Participate in forecasting study expenditures and resourcing needs. - Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. - Provide timely communication of any variances in budget forecast to the Director/Associate Director. - Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. - Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned. - Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency. - Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF. - Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned. - Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities. - Represent Clinical Management in departmental and cross-functional initiatives, as assigned. - Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts. - May have supervisory responsibilities including: + Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes. + Assuring compliance with departmental, SOP, compliance, and corporate training + Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities. + Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance. - Performs other duties, as assigned. **Qualifications/ Required** Knowledge/ Experience and Skills: - Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations. - Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW). - Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management. - Strong understanding of global regulatory requirements. - Strong communication, organization, planning, analytical, problem solving, and people management skills. - Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.) - Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.). - Ability to travel up to 25%. **Educational Qualifications** Required: - Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience. Preferred: - Previous supervisory experience. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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

Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget. **** - Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs. - Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents. - Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites. - Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs. - Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments. - Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. - Participate in forecasting study expenditures and resourcing needs. - Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. - Provide timely communication of any variances in budget forecast to the Director/Associate Director. - Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. - Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned. - Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency. - Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF. - Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned. - Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities. - Represent Clinical Management in departmental and cross-functional initiatives, as assigned. - Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts. - May have supervisory responsibilities including: + Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes. + Assuring compliance with departmental, SOP, compliance, and corporate training + Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities. + Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance. - Performs other duties, as assigned. **Qualifications/ Required** Knowledge/ Experience and Skills: - Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations. - Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW). - Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management. - Strong understanding of global regulatory requirements. - Strong communication, organization, planning, analytical, problem solving, and people management skills. - Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.) - Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.). - Ability to travel up to 25%. **Educational Qualifications** Required: - Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience. Preferred: - Previous supervisory experience. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

About the Job Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As a Dupixent Global Market Access & Pricing Dermatology Co-op in our Team, you'll support the global market access plan and operational excellence work streams including the coordination of key internal and external launch excellence events in collaboration with market access business partners (HEOR and pricing) and cross-functional brand team. This position provides an excellent opportunity for students with an interest in developing market access foundational knowledge, access strategy development, tactical implementation and launch excellence execution capabilities by working with a team of market access experts on one of the most exciting products at Sanofi. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Coordinate project management activities related to payer interactions such as payer advisory boards, negotiation readiness workshops, and market access affiliate training events Support market access launch excellence workstreams including project planning, dashboards, trackers, and reports Assist Dermatology TA leads in the development of global market access strategy/plan and deliverables (e.g., payer value story, payer objection handler) for assigned Dupilumab indications based on business needs Support Dupixent MAx launch execution and operations Collaborate with cross-functional teams to ensure alignment on market access strategies and tactics About You Basic Qualifications: Currently pursuing a bachelor's or advanced degree in Science, Engineering, Pharmacy, Business, Health Economics, Public Health, Policy/Government Affairs, or Marketing, or a related field at an accredited college or university with the expectation that you will complete your current degree by the Spring of 2028 Must be able to relocate to the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship Must be enrolled in an accredited college or university throughout the duration of the co-op/internship Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship Preferred Qualifications: Previous internship or coursework in pharmaceutical industry, healthcare, or related field Experience with project management tools and methodologies Knowledge of market access, health economics, or health technology assessment concepts Interest in dermatology therapeutic area Excellent written, verbal, and interpersonal communication skills Strong organizational skills with attention to detail Proficiency with Microsoft Office suite, particularly PowerPoint and Excel Self-motivated with the ability to work both independently and as part of a team Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Exposure to cutting-edge technologies and research methodologies. Networking opportunities within Sanofi and the broader biotech community. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.