Senior Manager jobs at U.S. Pharmacopeia - 133 jobs

Donations Engagement Manager - Remote Position
The U.S. Pharmacopeial Convention (USP 4.8
Senior manager job at U.S. Pharmacopeia
**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. **Brief Job Overview** This role is a non-supervisory position responsible for working with key customers and stakeholders in the excipients industry on acquisition and complete submission of information for USP documentary standards, primarily in the North America (NORAM) and Europe Regions. This role will be responsible for delivering USP monograph donations for excipients and other raw materials through effective and appropriate stakeholder engagement. The incumbent works directly with companies with raw materials or testing of raw materials that are included in FDA approved products/processes as well as with internal USP staff globally including: Program Units, Strategic Customer Development Managers, Scientific Experts, and Business Leaders. This includes management of day-to-day activities including company meetings, planning, reporting and tracking to ensure delivery of key targets and growth goals. This role requires excellent interpersonal and communication skills, with the ability to influence cross-functional teams and external stakeholders. This role is within the Regions & Program Operations Division and reports to the Donations Director. **How will YOU create impact here at USP?** As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments The **Donations Engagement Manager** has the following responsibilities: + Develops donation focused account strategies, driving ongoing collaboration and alignment across all relevant internal stakeholders/partners. + Lead monograph acquisition (donation) efforts globally, and as needed, with particular focus in NorAm and Europe at assigned companies. + Identify and develop key contacts for acquiring the information required to develop USP's public standards. This includes the development of new monographs, modernization of existing monographs, and compendial requests to address FDA comments on proposed monographs to the USP-NF. + Develops specific plans and performance targets that supports overall donations strategies. + Deliver on monograph donation targets, ensuring quality data/components for further development by Science and USP Expert Committees, in an expeditious and efficient manner + Educate, support, and assist the sponsor of a potential monograph with guidance related to USP and how USP fits into a comprehensive compendial strategy. + Regularly engages in business and relationship development activities with identified donors and other relevant stakeholders. Develops and nurtures relationships with key people and decision-makers within each account. Leverages internal USP resources to effectively position all relevant USP resources to further the mission of USP. + Regularly executes professional presentations to donors to include, but not limited to the C-suite, Regulatory Affairs, Quality and R & D departments (and their respective staff). + Develops an overall understanding of USP's business (Small Molecules, Biologics, Growth Programs) to ensure that conversations with donors can foster broader collaborative dialogue between USP and targeted donors. + Understands the relationship between USP, Regulatory and Commercial markets both domestically and internationally and how those relationships affect USP and external accounts. + Has ability to provide scientific and technical support to assigned donors. Leverage internal USP counterpart resources such as Science, SCD, Scientific Affairs and USP Education, for inquires and/or programs that need greater detail and program content expertise. + Maintains and updates account information for all assigned accounts. Updates contact management system with all relevant donor information. Uses information strategically to be proactive at engaging USP resources. Makes the requisite number of touch points (phone calls, emails, teleconferences, meetings, and customer visits) to assigned donor accounts to the responsible individuals and decision-makers on USP's standards development process, and opportunities for donor contributions, with a primary focus on monographs, and documenting calls, meetings and emails in Salesforce. + Supports donor events and workshops to enhance and promote the importance stakeholder contributions to the standards development process. Identifying contacts at assigned companies to work with USP on new monographs, monograph improvement and bulk material. Develop and report on understanding drivers and barriers for donations. + Keep track of the progress to goals, monthly. Help to increase our understanding of the relationship between USP, Regulatory and Commercial markets both domestically and internationally and how those relationships affect our Mission. + Works as part of a Team leveraging the resources in donations operations and donor recognition to support our donors and elevate the impact our donors provide for global public health. Travel can be up to 50%, both domestic and international. Perform other related duties as assigned. **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: + Bachelor's degree in chemistry, or a related science field, required or a business degree or related field. + Seven (7) years' experience in a life sciences role, preferably in the pharmaceutical, specialty chemical industry or contract laboratory services that does testing for the pharmaceutical industry or other evidence of experience in conducting USP-NF testing in an analytical laboratory. + Three (3) years of experience providing account management to pharmaceutical or chemical/laboratory supply channels. + Experience in life sciences related work with demonstrated customer facing engagement activities including but not limited to face-to-face interactions and digital touchpoints. + Good interpersonal skills, communication skills, and telephone manner required. + Advanced understanding of pharmacopeia and use of compendial standards + Advanced understanding of the pharmaceutical industry + The ability to influence without direct authority. + Results-driven with demonstrated successful outcomes. + Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner. + Ability to handle multiple priorities in a fast-paced environment. + Able to work flexible hours when needed, including travel between 40-60% of the time. **Additional Desired Preferences** + Experience using data analytical platform (e.g. Tableau) and CRM platform (e.g. Sales Force) a plus. + Previous donation/stakeholder engagement (including sales) experience a plus. + Experience with regulatory compliance, quality control, quality assurance or GMP background a plus. + Account management skills required. + Strong problem-solving skills with customer-centric approach. + Excellent relationship-building skills with stakeholders. + Excellent in person & virtual presentation skills. + Self-motivated and able to work in a fast-paced multi-task environment. + Combined education in Pharma science and business is highly preferred. + Proficiency with Microsoft Office, data query, analysis, and reporting. + Superior interpersonal skills: professionalism, collaboration, accountability, delegation, and customer service + Ability to build effective work relationships quickly and work collaboratively in a global setting both internally and externally. + Ability to effectively manage multiple competing priorities with high attention to detail. + Knowledge of USP products and services is highly preferred. + High business acumen abilities - can understand and deliver on business objectives. + High comfort with navigating through ambiguity and frequent change, and course-adjusting in the moment. + Demonstrated initiative and resourcefulness with good judgement. + Strong influence, negotiation, critical thinking, problem-solving and conflict resolution skills. **Supervisory Responsibilities** None, this is an individual contributor role. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Salary Range: USD $98,900.00 - $127,250.00 annually. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Technical Programs **Job Type** Full-Time
$98.9k-127.3k yearly 60d+ ago

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Senior Director, Expert Volunteer Operations
The U.S. Pharmacopeial Convention (USP 4.8
Senior manager job at U.S. Pharmacopeia
**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. **Brief Job Overview** This is a leadership role in Documentary Standards and Compendial Policy (DSCP) reporting to the Senior Vice President, DSCP. The Senior Director, Expert Volunteer Operations manages Expert Volunteer Operations, a set of complex functions related to USP's standards-setting processes, policies, approvals, communications, and improvements. The Senior Director, Expert Volunteer Operations, is responsible for critical functions including Expert Volunteer Engagement, Expert Committee Management, and Standards of Conduct Program. This position plays a leadership role for management of expert committee and volunteer activities, including transformation and continuous improvement of processes and policies. The incumbent also initiates, supports, and leads, as appropriate, related cross-divisional compendial activities related to USP COE Rules and Procedures. The incumbent interfaces with all parts and levels of the organization to fulfill their responsibilities including the Chief Science Office/Chair to the Counsel of Experts, DSCP Leadership Team, GSSD, GEA, and legal. The Senior Director, Expert Volunteer Operations will utilize leadership, influence, operational experience, regulatory knowledge, and communication abilities to identify and drive change related to USP's mission and the science vision. **How will YOU create impact here at USP?** As part of our mission to advance rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, operational excellence, and risk-based decision-making to ensure the development and utilization on globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The Senior Director, Expert Volunteer Operations is a key role in the organization that manages Expert Volunteer Operations, a set of complex functions related to USP's standards-setting processes, policies, approvals, communications, and improvements related to USP's expert volunteers. The Senior Director, Expert Volunteer Operations oversees a couple of critical compendial functions: Expert Volunteer Engagement, Expert Committee Management, and Standards of Conduct Program. USP has over 1,000 expert volunteers that are responsible for the standards scientific decisions and to ensure the integrity of the decisions, the support of volunteers on process and policy is critical. Moreover, the expert volunteers are volunteers so ensuring the experience is rewarding is essential, including the ability to solve scientific issues, network with peers, and contribute clearly to USP's mission. Therefore, this position plays a leadership role for management of expert committees and volunteer activities, including transformation and continuous improvement of processes and policies to ensure the integrity of USP's standard setting process. The incumbent also initiates, supports, and leads, as appropriate, related cross-divisional compendial activities related to USP Council of Expert Rules and Procedures. The incumbent interfaces with all parts and levels of the organization to fulfill their responsibilities including the Chief Science Office/Chair to the Counsel of Experts, DSCP Leadership Team, GSSD, GEA, and legal. The **Senior Director, Expert Volunteer Operations** has the following responsibilities: + Responsible for leading critical areas including the expert volunteer processes, standards of conduct, and expert committee managers. The position is responsible for enhancing the experience of our volunteers while also managing the process to ensure the integrity of the USP standard setting process. It requires a solution-oriented individual that can navigate rules while also being agile to incorporate innovative solutions to ensure quality, efficiency, and transparency. + Provide leadership to functions that support the expert volunteers, global science leadership, the Legal Department, and others to support ongoing standard-setting processes, policies, and associated activities, and to facilitate implementation of new and improved processes related to our exert volunteers. + Represent the Science Division in cross-functional initiatives to provide consultation and insights into USP's expert volunteers and their activities. + Oversees compendial stakeholder activities and their input to USP, managing USP's interactions with compendial stakeholders (industry and others). Works across the organization to ensure consistency and balance across functions with stakeholder interactions and to evolve USP's understanding of stakeholders' contributions and needs relative to USP's mission and strategies. + Responsible for compendial engagement with FDA on behalf of USP and works with GEA and others to manage interactions and ensure a continued strong relationship with FDA. + Performs the responsibilities of executive secretariat to the Council of Experts and manages all activities of the COE. + Maintains and updates applicable SOPs and other process documents and templates. + Performs all other job duties including special projects as requested or assigned. **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: + Minimum of 11-13 years of experience in organizations in government/regulatory, or related field. + Minimum of 3 years people leadership experience. + Demonstrated ability to establish strong working relationships and influence culture with all levels of people in an organization. + Ability to perform and supervise in a matrix environment. + Experience managing conflict of interest or ensuring the integrity of processes and systems. + Understanding of the sciences and/or the regulatory aspects of pharmaceuticals, biologics, food, dietary supplements, or healthcare Ability to build a team through mentoring, training, and supervisory skills. + Possesses extensive knowledge of applicable Federal Food, Drug and Cosmetic laws, regulations, and guidance. **Additional Desired Preferences** + Master's or higher degree in health, science, or law. + Understands USP's impact on compendial stakeholders and how stakeholders may work with USP. + Ability to absorb new complex material quickly and frequently. + Demonstrated ability to successfully manage multiple concurrent projects in a timely manner. + Excellent facilitation, communication, and presentation skills. + Excellent critical thinking and problem-solving skills. + Able to operate independently where appropriate yet understand when to escalate issues and how to establish effective working relationships in a team setting. **Supervisory Responsibilities** Yes, this role manages approximately 14 individuals, including a senior manager and director. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Salary Range: USD $202,000.00 - $262,150.00 annually. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Professional Programs **Job Type** Full-Time
$202k-262.2k yearly 37d ago
Sr. Manager, Governance Risk and Compliance
Fyllo 4.1
Remote
The Sr. Manager, Governance Risk and Compliance (GRC) is responsible for overseeing Included Health's regulatory compliance, risk management, and governance programs, ensuring compliance with healthcare regulations (HIPAA, HITECH, SOC 2), and building a robust GRC framework to protect PHI. This role plays a crucial role within the Governance, Risk & Compliance team, reporting directly to the Chief Information Security Officer. Responsibilities: Third-Party & Vendor Risk Management: Manage the complete third-party risk management (TPRM) program, from initial assessment to ongoing monitoring. Conduct security risk assessments for all vendors, especially those handling protected health information (PHI). Collaborate with Legal to review security language in vendor contracts and Business Associate Agreements (BAAs). Maintain the vendor risk register, track remediation of risks, and report on vendor risk exposure. Demonstrate success developing third-party risk governance programs with Legal, Security, and Procurement to increase efficiency and reduce friction across stakeholders. Experience implementing tiered vendor risk models and reassessment cycles to reduce manual tracking workload. Audit & Compliance (HIPAA, SOC 2) Manage all internal and external audits, including planning, evidence collection, and coordinating with auditors. Serve as the main point of contact for external auditors (e.g., for SOC 2, HIPAA). Oversee security controls (technical and procedural) to ensure continuous compliance with HIPAA, HITECH, and SOC 2 frameworks. Translate complex regulatory requirements into actionable security controls and procedures for technical and business teams. Track and manage the remediation of all audit findings. Experience creating standardized audit playbooks and evidence repositories. Experience owning an organization-wide compliance program to comply with audit framework(s). Strong ability to translate audit outcomes into business-oriented insights that directly impact riskreduction and process improvement. Enterprise Risk & Security Operations Manage the enterprise risk management program, including conducting annual risk assessments and maintaining the risk register. Develop, maintain, and test the company's incident response (IR) plan. Run security awareness programs, such as phishing simulations and tabletop exercises. Track remediation efforts for all identified risks. Produce concise, executive-ready risk reports that inform strategic decisions across departments. Client & Sales Security Support Lead responses to client and prospect security questionnaires, RFPs, and assessments. Develop and maintain a knowledge base of standard security responses and supporting documentation. Act as the security subject matter expert to support the sales and partnership teams. Coordinate and manage client-facing security audits and reviews. Security Policy & Documentation Extensive experience creating, reviewing, and maintaining clear security policies, standards, andprocedures. Create, review, and maintain clear security policies, standards, and procedures. Ensure all policies align with regulatory requirements (HIPAA, SOC 2) and industry best practices. Communicate policies and procedures to all employees and contractors. Experience embedding compliance checkpoints within existing or new operational processes (e.g.,change management, onboarding). Qualifications: Required 7+ years of experience in GRC, compliance, risk management, or information security roles, with at least 4 years in a management or leadership capacity Demonstrated experience managing a full-cycle third-party risk management (TPRM) programs, including conducting vendor risk assessments and reviewing security terms in contracts. Hands-on expertise leading external audits for major compliance frameworks, specifically SOC 2 Type 2 and HIPAA. Proven ability to build and manage an enterprise risk program, including conducting formal risk assessments (e.g., NIST-based) and developing/testing incident response plans. Direct experience serving as a security subject matter expert in a client-facing role, including leading responses to security questionnaires, RFPs, and customer audits. Exceptional technical writing skills with a history of creating, implementing, and maintaining a comprehensive set of security policies, standards, and procedures. Preferred Bachelor's degree in Computer Science, Information Security, Business Administration, or related field (or equivalent experience). Deep expertise in healthcare compliance regulations including: HIPAA Privacy Rule, Security Rule, and Breach Notification Rule HITECH Act and meaningful use requirements SOC 2 Type 2 (preferably with hands-on audit management experience) Professional certifications such as: CISSP, CISM, CRISC, CISA, GRCP, CHPS, CIPP/US Experience with additional compliance frameworks such as:ISO 27001/27002, ISO 27701, HITRUST, CSFFedRAMP, State RAMPPCI-DSS, State privacy laws (CCPA, CPRA, VCDPA, etc.) Experience with GRC platforms such as Vanta, Drata, OneTrust, LogicGate, Archer, ServiceNow GRC, or similar Knowledge of cloud security and compliance (AWS, GCP) Experience managing security awareness platforms (KnowBe4, Proofpoint, NINJIO, etc.) Physical/Cognitive Requirements: Prompt and regular attendance at assigned work location. Capability to remain seated in a stationary position for prolonged periods. Eye-hand coordination and manual dexterity to operate keyboard, computer and other office-related equipment. No heavy lifting is expected, though occasional exertion of about 20 lbs of force (e.g., lifting a computer \/ laptop) may be required. Capability to work with leadership, employees, and members in an appropriate manner The United States new hire base salary target ranges for this full-time position are: Zone A: $138,380 - $195,470 + equity + benefits Zone B: $152,218 - $215,017 + equity + benefits Zone C: $166,056 - $234,564 + equity + benefits Zone D: $179,894 - $254,111 + equity + benefits This range reflects the minimum and maximum target for new hire salaries for candidates based on their respective Zone. Below is additional information on Included Health's commitment to maintaining transparent and equitable compensation practices across our distinct geographic zones. Starting base salary for the successful candidate will depend on several job-related factors, unique to each candidate, which may include, but not limited to, education; training; skill set; years and depth of experience; certifications and licensure; business needs; internal peer equity; organizational considerations; and alignment with geographic and market data. Compensation structures and ranges are tailored to each zone's unique market conditions to ensure that all employees receive fair and competitive compensation based on their roles and locations. Your Recruiter can share details of your geographic alignment upon inquiry. In addition to earning a base salary, this role is eligible for a performance-based bonus. Details of the Annual Bonus Plan, including performance metrics, target incentives, and potential earnings, will be discussed during the interview process. Benefits & Perks:In addition to receiving a competitive pay, the compensation package may include, depending on the role, the following:Remote-first culture 401(k) savings plan through FidelityComprehensive medical, vision, and dental coverage through multiple medical plan options (including disability insurance) Full suite of Included Health telemedicine (e.g. behavioral health, urgent care, etc.) and health care navigation products and services offered at no cost for employees and dependents Generous Paid Time Off ("PTO") and Discretionary Time Off ("DTO")12 weeks of 100% Paid Parental leave Up to $25,000 Fertility and Family Building Benefit Compassionate Leave (paid leave for employees who experience a failed pregnancy, surrogacy, adoption or fertility treatment)11 Holidays Paid with one Floating Paid HolidayWork-From-Home reimbursement to support team collaboration and effective home office work24 hours of Paid Volunteer Time Off ("VTO") Per Year to Volunteer with Charitable Organizations Your recruiter will share more about the benefits package for your role during the hiring process. #LI-CG1 About Included Health Included Health is a new kind of healthcare company, delivering integrated virtual care and navigation. We're on a mission to raise the standard of healthcare for everyone. We break down barriers to provide high-quality care for every person in every community - no matter where they are in their health journey or what type of care they need, from acute to chronic, behavioral to physical. We offer our members care guidance, advocacy, and access to personalized virtual and in-person care for everyday and urgent care, primary care, behavioral health, and specialty care. It's all included. Learn more at includedhealth.com. -----Included Health is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law. Included Health considers all qualified applicants with arrest or conviction records in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, and California law.
$179.9k-254.1k yearly Auto-Apply 43d ago
Vice President, Growth and Strategy - Auto Sector
Kantar 4.3
Remote
We go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. To start a career that is out of the ordinary, please apply...Job Details We're the world's leading data, insights, and consulting company; we shape the brands of tomorrow by better understanding people everywhere. Our Automotive Practice colleagues are masters at using insights to resolve industry challenges. They help automotive brands define what they should stand for, reinvent and renew their offerings, reach audiences more effectively, and win with customers and prospects. We blend human expertise with technology and extensive data assets to deliver innovative insights to automotive brands everywhere. Why this job is important Kantar's Business Development team is comprised of the industry's most connected and influential commercial leaders. As a VP of Growth & Strategy, you'll be part of a positive, collaborative, and high-performing team responsible for generating sales revenue by identifying, cultivating, and closing business that expands our footprint with existing clients and brings new clients into Kantar's Automotive vertical. You are a veteran of the automotive industry, deploying a disciplined and well-adapted sales process to drive short and long-term revenue growth. You have depth knowledge of the challenges of Automotive marketers and strategists today, and you're well-versed in the role market research, data, and analytics can play in addressing those challenges. You're customer-centric, possess executive presence, and excel at active listening, probing to uncover critical problems, and consulting with prospective clients on Kantar's solutions. You bring deep competency in consultative selling and negotiating with buyers, legal, and procurement, to drive both maximum client satisfaction and Kantar revenue. The right candidate is energised by and immersed in the automotive industry, bringing a point of view to clients that opens doors to new business. You'll spend approximately 70% of your time on direct, consultative sales, 20% contributing to smart, industry-relevant study design and delivery, and 10% informing and crafting thought pieces to elevate Kantar's automotive practice. You are a strategist with solid competency in stakeholder management. You're magnetic, passionate about human behaviour, and dedicated to helping clients improve their business strategies to drive sales, brand, and enterprise growth. Detail-oriented yet empowering, you play a role in bringing others along in their career development. You're an empathetic and inclusive leader, contributing positively to Kantar's culture and success through influence and value-add. You balance professionalism with genuine fun, offering ideas and perspectives to improve yourself and those around you. Key Responsibilities Identify new business opportunities by analysing marketplace data, leveraging your established network, and hunting for new buying centers. Develop account strategies and create relationships with key contacts and prospective clients using both the Kantar client network and your personal connections. Lead all aspects of the sales process, from prospecting to qualification to closing. Generate new sales revenue across Kantar's ecosystem of solutions: Brand Strategy, Brand Performance, Creative Testing, and Media Measurement. Log sales activity and maintain your sales pipeline, including revenue forecasts and weekly updates, through our internal CRM. Lead RFP and proposal development, collaborating with internal teams, coordinating client timelines, and developing pitch collateral that resonates with clients and tells a differentiated story. Conduct client meetings to build and maintain high levels of customer satisfaction across all solutions and engagement with Kantar. Immerse yourself in the automotive industry, bringing a point of view that informs client meetings, study design, and reporting. Understand the competitive landscape and report back to the organisation on points of differentiation; contribute to written and recorded automotive thought leadership suitable for external publication. Negotiate deals that adhere to Kantar's financial guidelines, understanding the financial implications of each engagement. Actively contribute to Automotive industry organizations to drive Kantar's salience and build new prospect relationships. What You'll Bring Deep understanding of the US automotive industry, with significant experience working at an automotive manufacturer, media agency with an automotive focus, or in automotive/mobility practices at top consulting firms. Proven success in a commercial senior-level role, with a strong network in the automotive ecosystem. Confidence and credibility engaging with C-suite and senior stakeholders. A natural connector with a proven track record of winning new business and building executive-level relationships. Familiarity with market research, data, or insights solutions, or senior level experience in marketing or brand. Ability to navigate complex organisations and influence cross-functional teams in a matrixed environment. A hunting mentality with experience using your network of client relationships and generating leads. Proven success generating revenue with multi-million-dollar new business/new logo accounts. Demonstrated ability to translate sophisticated concepts into concise, insightful messaging. Highly motivated, self-starter, driver of change and transformation. Shown cross-portfolio collaboration and leadership. What's in it for you We provide a highly competitive benefits package! Medical plans with comprehensive, affordable coverage for a range of health services Health Savings Account/FSA Dental, Vision and benefits to cover unique healthcare needs Wellness Program 401k with matching Tuition Reimbursement, Commuter benefits Unlimited PTO At Kantar, we go beyond the obvious, using intelligence, passion, and creativity to inspire new thinking and shape the world we live in. Apply for a career that's out of the ordinary and join us. We want to create an equality of opportunity in a fair and supportive working environment where people feel included, accepted, and are allowed to flourish. We want to create a more diverse community to expand our talent pool, be locally representative, drive diversity of thinking, and better commercial outcomes. Kantar is committed to inclusion and diversity; therefore, we welcome applications from all sections of society and do not discriminate on the basis of age, race, religion, gender, pregnancy, sexual orientation, gender identity, disability, marital status, or any other legally protected characteristics. PRIVACY DISCLOSURE: By applying to this opportunity, you consent to the personal data you provide to us being processed and retained by The Kantar Group Limited (“Kantar”). Your details will be kept on our Internal ATS for as long as is necessary for recruitment purposes. The salary range for this role in Detroit is $140,000 - $190,000/year. Your final base salary will be determined based on several factors, which may include but are not limited to location, work experience, skills, knowledge, education, and/or certifications. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #LI-ED2 #LI-Hybrid #LI-DNP Location Michigan, Work from HomeUnited States of America Kantar Rewards Statement At Kantar we have an integrated way of rewarding our people based around a simple, clear and consistent set of principles. Our approach helps to ensure we are market competitive and also to support a pay for performance culture, where your reward and career progression opportunities are linked to what you deliver. We go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. Apply for a career that's out of the ordinary and join us. We want to create an equality of opportunity in a fair and supportive working environment where people feel included, accepted and are allowed to flourish in a space where their mental health and well being is taken into consideration. We want to create a more diverse community to expand our talent pool, be locally representative, drive diversity of thinking and better commercial outcomes. Kantar is the world's leading data, insights and consulting company. We understand more about how people think, feel, shop, share, vote and view than anyone else. Combining our expertise in human understanding with advanced technologies, Kantar's 30,000 people help the world's leading organisations succeed and grow.
$140k-190k yearly Auto-Apply 17d ago
Senior Manager, Reimbursement Access - West
Xeris Pharmaceuticals 4.2
Remote
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.
$130k-220k yearly Auto-Apply 1d ago
Sr. Manager, GxP Compliance Officer
Fenwal 4.3
Remote
Job SummaryThe Sr. Manager, GxP Compliance Officer (GCO) assures that all manufacturing sites and R&D Centers having activities with US-FDA are in compliance with US-FDA regulations, including but not limited to, cGMPs, cGLPs, and electronic records. This includes global facilities within Fresenius Kabi for importation of API or finished products to the US market. This position organizes and promotes company-wide US-FDA quality and compliance improvement and compliance improvement efforts. Salary Range: $140,000-$165,000 • Position is eligible to participate in a bonus plan with a target of 14% of the base salary (include only if applicable to the grade level) • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities Responsible for leading, coordination, verification and tracking of global compliance activities within the pharmaceutical division Evaluation of Investigations and Changes that could have an impact on regulatory commitments Identification and remediation of plant quality and compliance risks through evaluation of tradition and non-tradition metrics, audit results, gap assessments, etc Support plant on strategy and compliance plans for identified gaps Lead/manage working groups to ensure mitigation plans are executed Responsible for specific preparation of manufacturing sites and I&D Centers for upcoming US-FDA inspections, including but not limited to: Training of plant staff for general inspection aspects and behaviors, as well as specific training for subject matter experts Performance of mock inspections to evaluate the plants readiness for FDA inspection Design and deliver need-based training to specific plants in response to identified gaps Direct participation and support during US-FDA inspections (inspection room and back office), including: Immediate guidance and support during inspections Support and guidance in preparing response to FDA-483 observations Independent review of Effectiveness of assigned FDA-483 CAPA May also include inspections by local authorities when related to Mutual Recognition agreements Responsible for identification of new FDA cGMP trends and development of strategies to fulfill new expectations Strategic optimization and harmonization of cGMP and quality related processes to continuously improve pharmaceutical quality and compliance of Fresenius Kabi products Preparation of global quality management documents (e.g. SOPs, guiding documents, working instructions) Contribution, execution and management of global projects Collaborate with other corporate quality functions on the execution of strategic goals Communicate findings and risks to plant management as well as senior quality management All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities Requirements Minimum of Bachelor's degree required. Advanced degree in chemistry, molecular biology, microbiology or engineering field is highly desirable. Accomplished US-FDA compliance expert. Experience: 8+ years including practical experience in pharmaceutical industry and/or US-FDA. A thorough knowledge of drug transfer processes, manufacturing processes for aseptically filled, terminally sterilized and lyophilized pharmaceuticals, cGMPs, ICH guidelines, regulatory compliance. Professional experience in pharmaceutical industry, including technological understanding of manufacturing pharmaceuticals and combination products, aseptic processes, validation and qualification, risk management, root cause analysis and investigation management is required to be successful in this position. Previous experience in executing and/or managing GxP audits or inspections a preferred Ability to effectively interact with and influence plant personal and leadership regulators, global partners or affiliates, industry executives, trade organizations. Established contacts to US-FDA are beneficial Strong analytical problem-solving experience is essential. Demonstrated prior experience in leading and motivating teams to conceptualize and develop innovative and creative solutions that are robust and sustainable. Ability to manage multiple complex situations, where precedent may not have been established. Ambiguity and uncertainty will often be associated within the framework of decision making facing this individual. Ability to travel frequently (both domestically and internationally) is required. Project Management, working in a Quality Management System and strong communication skills are required for this position. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
$140k-165k yearly Auto-Apply 60d+ ago
Director, Risk Evaluation & Mitigation Strategy (REMS)
Agios Pharmaceuticals 4.5
Remote
Director, Risk Evaluation & Mitigation Strategy (REMS) Who we are:At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built. To learn more, visit www. agios. com and follow Agios on LinkedIn and X. The impact you will make:Agios Pharmaceuticals is searching for a dynamic Director, Risk Evaluation & Mitigation Strategy (REMS) to join our growing Medical Safety & Risk Management team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Director, Risk Evaluation & Mitigation Strategy (REMS) will be responsible for serving as the organizational lead for the design, implementation, and oversight of REMS programs. This role combines strategic leadership, operational execution, and cross-functional collaboration. The Director will reside within Medical Safety & Risk Management (MSRM) and work closely with Regulatory Affairs, Medical Affairs, Market Access, Commercial, Supply Chain, and Legal teams, as well as external vendors, to deliver high-quality REMS programs that meet FDA requirements and support product success. What you will do:Strategic LeadershipLead the implementation, oversight, and evaluation of REMS in alignment with the broader Program Strategy. Act as the in-house REMS expert across the organization. Monitor regulatory changes and proactively update strategies, policies, and procedures to align with FDA requirements and best practices. Partner with cross-functional teams to integrate REMS considerations into product development, launch, and lifecycle management strategies. Cross-Functional & Matrix LeadershipResponsible for the cross functional development of implementation and operational plans that support the REMS. Accountable for REMS management and oversight in accordance with time, cost and quality commitments. Coordinate matrix teams across MSRM, Regulatory Affairs, Medical Affairs, Market Access, Marketing, Quality, Supply Chain, Commercial, and Legal. Communicate REMS strategy, progress, and compliance metrics to senior management and governance committees. Operational ExecutionEnsure timely execution of operational aspects of REMS and related activities. Review REMS related documentation, including FDA requests, and approve vendor-authored documents as required. Oversee vendor interactions and management of day-to-day REMS operations, ensuring compliant enrollment, data collection, monitoring, and reporting. Support integration of call centers, technology platforms, and other operational infrastructure as appropriate. Approve and manage program deliverables, budgets, and timelines. Develop and oversee KPIs, dashboards, and compliance metrics to measure program effectiveness. Ensure readiness for regulatory inspections and audits; support noncompliance issue resolution, CAPA development and execution as needed. What you bring:QualificationsBachelor's or Advanced degree in science, pharmacy, nursing, healthcare, or related field. 10+ years of pharmaceutical/biotech industry experience, with expert knowledge and proven track record on REMS operations Proven track record in vendor management, program implementation, and compliance oversight. Demonstrated success leading cross-functional and matrix teams. Strong knowledge of FDA REMS requirements and evolving regulatory landscape. Experience implementing SOPs and compliance frameworks. Excellent communication, project management, and organizational skills. PreferredAdvanced degree (PharmD, PhD, MSN, MPH, MBA, or related). Audit and/or inspection experience in REMS and/or pharmacovigilance Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the , we still encourage you to apply. You may be just the right candidate for this role or another opening! Work Location:Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description. What we will give you:Deliberate Development. Your professional growth as one of our top priorities. Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best. Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website. Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance. The current base salary range for this position is expected to be between $183,549 - $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries. Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce. Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked. Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
$183.5k-275.3k yearly 15h ago
Senior Manager, Pharmacovigilance
American Regent 4.7
Remote
The Senior Manager, Pharmacovigilance (PV) will be responsible for organization and managing of activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational compounds. Managing rapid and accurate data entry of AE reports into the safety database, coordinate follow-up as appropriate, maintain knowledge of SOP's, guidance documents and the safety database under the direction of the Sr. Director, Head of Pharmacovigilance. Essential Duties and Responsibilities • Responsible for receiving and processing AEs reported to American Regent, Inc. from any internal or external source of any product sold or distributed by the company and its divisions. • Responsible for managing all PV operational activities. • Interact with Medical Monitors, Project Managers, CRAs, Project Coordinators, external clinical site investigators, nurses, pharmacists, patients, and outside corporate manufacturing partners/distributors in order to receive, follow-up, and report AEs according to company SOPs. • Work with individuals in each division and across various departments (regulatory affairs, clinical R&D, medical affairs, and quality assurance) interfaced with the Pharmacovigilance process. • Coordinate investigations with Quality Assurance (QA) Department. • Provide input into SOPs, updates, and modifications to initiate appropriate changes. • Provide input on end-user's issue with safety database. • Review of study safety tables and listings. • Supervise intake of AEs, making certain all required elements of a safety report are captured and that FDA guidelines are followed. • Daily distribution of adverse event reports to drug safety associates. • Complies and distributes monthly reports. • Oversees PV agreements (completion, revision, and resolution of partner issues, maintains spreadsheets/PV mailbox distribution list). • Oversees, tracks, and participates in reconciliation process concerning marketed products that are the subject of safety data exchange agreements. • Answer company queries pertaining to safety database. • Oversees completion of monthly ad-hoc literature searches and yearly contract renewals. • Oversees quarterly process for copying of PV files for forwarding to headquarters liaise with cross functional teams such as: QA/RA/Medical Affairs/Clinical R&D for resolution of any PV-related issues. • Participates in quality initiatives and any associated deviations as needed. • Tracks case processing metrics for monthly reports to senior management/leadership. • Prepare SAE narratives and collaborate with CROs/vendors for SAE reconciliation. • Review and verify AE and concomitant medication coding via MedDRA and WHO Drug coding internally and with CROs/vendors. • Identify safety signal and coordinate with Medical Directors as to their interpretation. • Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. • Healthcare Professional, Pharm.D. or related Science Degree, BSN/RN/MSN required. • Minimum of 8 years of experience in pharmacovigilance within pharmaceutical industry required. • 3+ years of experience in a supervisory or managerial role required. • Knowledge of FDA Regulations for industry governing reporting of adverse drug experiences required. • Knowledge/experiences with handling of adverse drug experiences. • Experience with internal and external audits is preferred. • Excellent written and oral communication skills, strong analytical and problem-solving skills, strategic thinking, prudent decision making, proactive behavior, and the ability to collaborate effectively across multidisciplinary teams are essential. • Strong technical aptitude with safety databases (e.g., Oracle ARGUS Safety Database) is required. • Experience in authoring and reviewing internal documents such as Standard Operating Procedures, maintenance schedules and operating manuals. • 10% travel required for team meetings and potential audits. Expected Salary Range: $165,000-185,000 The salary range, is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a widerange of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.
$165k-185k yearly Auto-Apply 3d ago
Senior Manager, Clinical Applications - U.S. - Remote
Worldwide Clinical Trials 4.4
Durham, NC jobs
Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the Information Technology Department does at Worldwide The IT department is made up of seasoned professionals united in one common goal: to keep Worldwide's technical infrastructure operating at the highest levels for our employees and our customers. We are a global team comprised of numerous professionals including cyber security, artificial intelligence, IT helpdesk, application support, and more. What you will do Develop, implement, and oversee functional Application management plans for the portfolio of systems. Manage and document application, system, and performance controls in line with industry best practices. Manage application operations activities and staff; monitor, review, investigate, and escalate system support events in technical areas relating to application performance. Develop, implement, and maintain functional metrics such as KPIs and QTLs, inclusive of Uptime, System/Capability Utilization. Form partnerships with Business Owners and IT Infrastructure to ensure Enterprise class support is given to these business-critical systems. Partner with Computer Systems Validation and Technical Delivery to ensure that validation and regulatory documentation is completed to ensure compliance with GxP standards. Work with Worldwide business clients to document business requirements for projects and applications interfaced with it. Lead Data Governance across team ensuring appropriate rigor and discipline is present across data integration, mastering, and management for all systems within the clinical portfolio. Perform system configuration and functional testing ensuring it meets requirements and specifications. Partner with Technical Delivery to Write and review validation scripts and user acceptance testing for new workflows and processes. Provides technical expertise and training to teammates and business users. Work with project teams and users to resolve or escalate technical issues. Estimate and plan implementation activities. Work with software vendors to understand and support existing and future functionality. Co-ordinate system Disaster Recovery (DR) testing as required. Write, review, and update Standard Operating Procedures, Work Instructions and Business Guidelines for both IT technicians and end users What you will bring to the role Strong planning and scheduling skills. Excellent written and verbal communication skills. Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment. Ability to exercise sound judgment and make decisions independently. Must be self-motivated and able to work with minimal supervision. Able to succeed and contribute to a team environment. Proficiency in MS-Office and cloud-based systems and applications. General Knowledge in HIPAA, data privacy and security, GxP, and FDA regulations governing validated applications, 21CFR Part 11 and ICH E6 (R2) Good Clinical Practice. A proven track record in setting expectations, providing feedback, and guiding professional growth ensures both organizational goals and individual aspirations are achieved. Your experience Bachelor's degree preferably in a technical discipline. Minimum of 8 years' experience managing application performance, health, and availability or equivalent experience. Demonstrated expertise in people leadership includes inspiring, coaching, and developing diverse teams, while effectively managing team dynamics, resolving conflicts, and recognizing individual strengths for optimal performance. Familiar with databases like Oracle or SQL Server. Knowledge of Quality Assurance functions. Experience in the pharma, CRO, or other health-related industry. We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit ***************** or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
$90k-133k yearly est. Auto-Apply 60d ago
Engagement Manager, Analytical Consulting
Precision Medicine Group 4.1
Remote
Evidence Solutions is an award-winning global healthcare market access consultancy. We excel at understanding the ever-changing and complex healthcare market and helping clients solve issues including distribution, launch pricing and contracting, access improvement, formulary inclusion and product value positioning. Would you consider yourself a highly organized and detail-oriented project leader? Are you a clear and confident communicator among both internal teams and in front of clients? Do you thrive within a smaller team and company that is highly collaborative? If you're a born leader and problem-solver and enjoy when no day is the same - keep reading. Engagement Managers oversee and mentor analysts/consultants, facilitate project teamwork, lead client interaction, develop presentations and are responsible for key facets of the assigned client business. They carry out the client's vision and ensure proper alignment of resources to deliver against it, leading the team to deliver exceptional work and client satisfaction. Essential functions of the job include but are not limited to: Building and leading all aspects of project works streams Providing project teams with clear direction Managing project plans to fully meet all client deliverables Developing relevant pricing and market access strategy, leveraging analytics Developing client relationships Attending and leading client meetings Helping manage client expectations Ensuring work product contains accurate data that is correctly cited in addition Developing expertise in specific areas and demonstrating such expertise by leading development of products, pitches, IP, etc. Contributing to certain areas of practice development (e.g., mentoring, training) Qualifications: Minimum Required: Bachelor's degree, with a record of academic excellence 3-5 years of consulting or related business analytics experience, strategy experience a plus, within the healthcare space (pharmaceutical, biotech, medical device, diagnostics industry) Experience of global pricing & market access, developed via experience in healthcare consulting or within the pharmaceutical industry (don't need global pricing experience) Payer, Provider and Patient analytics utilizing Rx Claims, Mx Claims, Remittance Data and Formulary insights a must, Pricing strategy experience a plus Strong MS Office literacy e.g., Word, PowerPoint, Excel Ability to work across multiple workstreams and create a seamless story across multiple data outputs Ability to work with various data assets: open and closed claims, formulary data, projected TRx plan level data, sell in data, affiliation data, patient services data and other publicly available data. Strong Coding Skills Strong Presentation Skills Preferred: Academic concentration in Science, Engineering, Computer Science, Economics, Business Master's degree or PhD Synthesizing insights and developing recommendations from primary and secondary research Directing primary research with stakeholders (payers, key opinion leaders, physicians) I would Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$105,000-$182,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
$105k-182k yearly Auto-Apply 1d ago
Director, CAR-T - Oncology Strategy
Astrazeneca 4.6
Gaithersburg, MD jobs
AstraZeneca is a global, science-led biopharmaceutical company dedicated to discovering, developing, and commercializing medicines for some of the world's most serious diseases. Oncology Business Unit Driven to eliminate cancer as a cause of death, our Oncology team challenges the ordinary, pushing boundaries to deliver life-changing treatments. We're united by one goal: ensuring no patient is left behind, at any stage of disease. Introduction of the role: As Director, Lifecycle and Pipeline, you will shape and execute strategies for our innovative oncology pipeline alongside top experts in R&D and the Oncology Business Unit. Accountabilities: Lead the collection and analysis of data to inform project strategies and investment decisions across all stages of development. Deliver detailed market assessments, revenue forecasts, and asset valuations using market research and competitor insights. Provide strategic recommendations, leveraging excellent analytical, consultative, and communication skills to influence senior leaders and stakeholders. Build strong relationships, challenge ideas constructively, and drive impactful decision-making based on scientific evidence. Essential skills/experience: BA/BS degree 6+ years in biopharmaceuticals or related fields Experience in oncology Experience in CAR-T Familiar with the oncology drug development process and necessary scientific, commercial and strategic considerations Understanding of clinical data and clinical trial design Proven experience in pharmaceutical industry or consulting in which you have contributed to the global pipeline strategy e.g. market assessment, competitor analysis, forecasting Analysis and fact-based decision-making Working with data and/or a science research/ bio-pharmaceutical environment Understanding of general business and core marketing principles and application to future healthcare market challenges Able to influence without authority and establish and maintain credibility with senior audiences Resourceful, motivated, decisive and proactive; must be able to manage multiple priorities in a fast-growing organization Experience of setting up short- and long-term strategic plans Highly intellectually capable with agility and adaptability Motivated by working in a fast-paced field with clear societal impact Desirable skills/experience: PhD in life sciences The annual base pay for this position ranges from $229,303 to $343,954. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 22-Jan-2026 Closing Date 30-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
$229.3k-344k yearly Auto-Apply 1d ago
P2P Senior Manager
Zoetis 4.9
San Jose, CA jobs
The Senior Manager, Procure-to-Pay (P2P) will play a strategic leadership role, driving transformation and operational excellence within the P2P process. The role will report to the Costa Rica Senior Director of Finance Shared Services and will focus on improving efficiency, managing risk, and aligning processes with the company's overall business goals. As a senior leader, this position will be accountable for shaping the future of P2P, driving high-value projects, and establishing strong partnerships across Finance and other global business units. MAIN RESPONSIBILITIES Strategic Leadership and Transformation * Lead global transformation efforts to enhance the P2P process, aligning it with industry best practices, digital transformation strategies, and business needs. * Drive alignment with senior leadership and cross-functional teams to integrate P2P into broader company goals and strategies. Process Optimization and Standardization * Standardize and streamline end-to-end P2P processes across all regions, ensuring alignment with compliance and corporate governance. * Implement innovative process improvements leveraging automation, AI, and digital tools to increase efficiency and reduce manual tasks. * Govern and maintain P2P process documentation, including policies, procedures, and guidelines. Technology and Automation Leadership * Lead the deployment of P2P solutions (e.g., Ariba, SAP, Concur) and ensure seamless integration with other systems. * Collaborate with IT and external vendors to ensure the continuous improvement and performance of P2P platforms. * Sponsor global automation projects to reduce costs, improve compliance, and enhance user experience. Stakeholder Engagement and Change Management * Act as a trusted partner to senior leaders in Finance, fostering collaboration and alignment on P2P initiatives. * Lead change management efforts to drive adoption of new systems and processes, ensuring all stakeholders are informed and trained. * Serve as a point of escalation for critical issues, ensuring timely resolution and stakeholder satisfaction. Performance Metrics and Continuous Improvement * Define and monitor key performance indicators (KPIs) and benchmarks for P2P processes to assess effectiveness and identify areas for improvement. * Lead data-driven decision-making by analyzing trends, identifying gaps, and proposing solutions. Governance and Risk Management * Manage access controls, approval workflows, and authorization limits in accordance with governance standards. * Ensure a robust compliance environment with applicable policies, procedures and processes incl. SOX requirements, tax and other statutory requirements of the local markets within the P2P area EXPERIENCE, SKILLS, KNOWLEDGE Education/Experience * Bachelor's degree in Business Administration-Finance * Requires min 10 years of experience with Procurement, Accounts Payable, Payments, and Travel and Expense in a global scale * At least 10+ years of experience in P2P processes within a Shared Services model with proven success in multi-national companies Skills/Abilities * 7+ years advancing people leadership, inspiring, and developing teams to achieve their full potential. * Ability to work in culturally diverse teams with many levels of personnel and establish professional relationships. * Demonstrated proficiency in accounting * Experience working with ERP systems (preferably SAP S/4HANA, Ariba, Concur). * Knowledge, insight, and experience in financial administrative and accounting processes. * Experience working in a customer-focused environment. * Proficiency in English. * Excellent oral and written communication skills. * Proven ability to work in a team environment with good analytical and problem-solving skills. * Demonstrated interpersonal skills, customer management skills, analytical, change management, and communication skills. We Offer: * Exposure to a dynamically growing leader of the global animal health-care segment * Competitive salary and benefits package (private healthcare and insurance, Meal allowance, Parking, corporate events for employees) * Professional and supportive working environment * Co-funding of professional qualifications and program Tuition reimbursement * Modern office space with Doctor's office * Possibility to work remotely from home on selected days * Asociación Solidarista Full time
$136k-177k yearly est. Auto-Apply 60d+ ago
Director of Strategy & Business Operations - Healthcare & Clinical Research
Paradigm Health 3.8
Remote
Paradigm is rebuilding the clinical research ecosystem by enabling equitable access to trials for all patients. Our platform enhances trial efficiency and reduces the barriers to participation for healthcare providers. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm's seamless infrastructure implemented at healthcare provider organizations, will bring potentially life-saving therapies to patients faster. Our team hails from a broad range of disciplines and is committed to the company's mission to create equitable access to clinical trials for any patient, anywhere. Join us, and bring your expertise, passion, creativity, and drive as we work together to realize this mission. As the Director of Strategy and Business Operations, a member of the Paradigm Strategy Team reporting to the Head of Strategy, your role will be multifaceted and pivotal to the company's success. You will be responsible for driving effective strategic decision making and ensuring operational excellence across functional areas, including product development, commercial, clinical operations, finance, business development, and corporate development. By facilitating structured, data-driven decision-making, effective cross-functional collaboration and execution, and efficient and measurable business processes, you will help shape the growth of our business in the right directions while enabling efficient and scalable execution. Your ability to cultivate and manage strong working relationships with colleagues across functions will be essential for the successful growth of our company. Lastly, your ability to bring a multi-disciplinary skill set-including strategy, operations, project management, and financial analysis/modeling-to bear on a wide range of challenges will be essential to your success in this exciting and challenging role. Our Ideal candidate is someone with 3+ years experience at a top tier consulting firm, where you worked on Healthtech or life sciences (critically, on the consulting/strategy side (not technology implementation or accounting), Plus 2+ years post-consulting at a early/mid stage startup healthtech, in clinical trials or RWD or biopharma SaaS or another loosely related area. What you'll do: Strategy: Lead and support cross-functional workstreams to drive sound, data-driven, and efficient strategic decision-making and execution Bring structured thinking, clear frameworks, and clear, concise communication to strategy work to drive effective decision-making and execution, with strong alignment across executive leadership and functional leaders and teams Support strategy development with data-driven analysis and modeling, including financial models and forecasts Build a deep, data-driven understanding of the overall market (US and ex-US, oncology and non-oncology), the provider landscape, the trial sponsor landscape, the competitive landscape, the landscape of potential partners and acquisition targets, current policy and policy trends, and other areas Infuse data-driven insights and an analytical mindset into strategic decisions while balancing the urgency required to succeed as a startup company Enhance Paradigm's ability to communicate clearly and concisely internally and externally, including with our Board of Directors Business Operations Excellence: Provide effective leadership, facilitation, and project management to drive efficient and effective cross-functional execution of strategic workstreams Design and help implement efficient, measurable operational processes to enable efficient, scalable execution across functions Establish and maintain best practices for project management, quality assurance, and performance metrics Drive continuous improvement efforts to enhance operational efficiency, productivity, and customer satisfaction long-term vision Who you are: BA/BS degree with equivalent work experience preferred 4+ years of strategy and/or business operations experience in healthcare technology or closely related healthcare sectors (clinical research, drug development, clinical trial operations and/or technology, etc.) Strong understanding of the US healthcare system, with deep experience with life sciences companies, health systems, or both Demonstrated ability to learn quickly and to succeed in highly complex, ambiguous, and dynamic environments Demonstrated ability to lead and facilitate, including cross-functional teams, and to drive impact and results with independence and initiative, including with technical teams Demonstrated experience, presence, and credibility with senior executives sufficient to drive decision-making and alignment on challenging, complex strategic questions Excellent quantitative skills, including market sizing, forecasting, and other modeling and analysis Excellent communication skills, including both written and verbal Mission-driven commitment to improving healthcare Mission-driven commitment to diversity, equity, and inclusion The base compensation range is $180,000 - $225,000 USD per year. Actual salaries will vary based on candidates' qualifications, skills, and location. What You'll Receive: Paradigm Health offers a comprehensive Total Rewards package to support your well-being and success, including: Competitive health, dental, and vision insurance Mental health support for you and your family through Spring Health Equity package Unlimited paid time off (PTO) 16 weeks of paid parental leave Flexible work options - remote and hybrid arrangements Company-paid life insurance Company-paid short-term and long-term disability coverage One Medical membership 401(k) plan with company match At Paradigm, we are committed to providing equal employment opportunities to all qualified individuals. We encourage and welcome candidates from all backgrounds and perspectives to apply for our open positions. We are interested in all qualified individuals and ensure that all employment decisions are based on job-related factors such as skills, experience, and qualifications.
$180k-225k yearly Auto-Apply 7d ago
Senior Manager, Global Regulatory Affairs
Otsuka America Pharmaceutical Inc. 4.9
Annapolis, MD jobs
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.
$150k yearly 60d+ ago
Senior Manager, Clinical Management (Early Phase)
Otsuka America Pharmaceutical Inc. 4.9
Annapolis, MD jobs
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.
$150k yearly 14d ago
Director, External Expert Strategy & Engagement
Otsuka America Pharmaceutical Inc. 4.9
Annapolis, MD jobs
The Director, External Expert Strategy & Engagement is a critical role responsible for defining, standardizing, and overseeing the company's global strategy for engaging a broad spectrum of external stakeholders. This includes Key Opinion Leaders (KOLs), Digital Opinion Leaders (DOLs), Payers/Access Stakeholders, Academic/Integrated Health Systems, Patients/Caregivers, and Patient Advocacy Groups. The role is accountable for establishing the governance, process clarity, and technological infrastructure necessary to ensure coordinated, high-value, and non-transactional interactions across all functional areas, distinguishing tactics based on the asset lifecycle stage (Early vs. In-line). This position reports directly to the Executive Director of External Engagement and Field Excellence. **** **Key Responsibilities:** **Strategic Governance and Accountability** + Establish clear accountability and process ownership for all external expert engagement activities, defining roles and responsibilities across the Medical Affairs (GMA) function to address the current pain point of limited clarity on accountabilities and responsibilities. + Develop and implement a standardized global strategy for external engagement that distinctly tailors objectives based on asset lifecycle (e.g., Early Asset engagement must focus on obtaining input from KOLs and Payers on trial design and clinical/economic value). **System and Data Management** + Coordinate with stakeholder engagement liaisons (from GMA, Commercial, Clinical Development, Market Access, Patient Advocacy and Stakeholder Management, Corporate Communications, and Government Affairs) and IT to migrate multiple, overlapping stakeholder lists. + Drive process adherence for the consistent upkeep and governance of the centralized external stakeholder list, ensuring the database accurately tracks engagement across all categories of stakeholders (e.g., Patients/Caregivers, Academic Systems, Digital Opinion Leaders). + Champion the use of the centralized system to track all medical expert interactions, contact attempts, and strategic insights captured. **Coordination and Best Practices** + Facilitate connections between the designated primary stakeholder lead contact and any internal team member seeking subsequent outreach to prevent multiple concurrent communications and requests. + Encourage and mandate best practices for GMA preparation before any stakeholder outreach, ensuring all engagement is high-quality and strategically aligned. + Partner with the Training team to develop standardized training and resources for internal teams on proper engagement protocols, compliance guidelines, and use of the centralized Veeva system, highlighting the specific goals for engaging each stakeholder group. + Collaborate with Global Training Lead to coordinate any needed training on external engagement processes and/or capabilities. + Consider technology and AI to support workflow improvement. **Qualifications:** **Education and Experience:** + Advanced scientific or clinical degree is required (PharmD, MD, PhD, or equivalent). + Minimum of 8 - 10 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 5 years in Global Medical Affairs, Strategic Operations, or an equivalent function focused on External Expert/KOL Engagement. + Proven experience in designing, implementing, and managing global engagement processes across multiple therapeutic areas and across different asset lifecycle stages. + Demonstrated success in leading a complex cross-functional project (e.g., system migration, process standardization) involving IT and multiple business units. **Skills and Competencies:** + Exceptional ability to drive process governance and change management across a global matrix organization. + Superior Stakeholder Management and influencing skills, capable of gaining consensus and driving compliance among diverse functional leaders (Commercial, Clinical, Global Medical Affairs). + Strong technological acumen with proven experience working with Veeva or similar management platforms for centralized data management. + Excellent communication and presentation skills, with the ability to articulate the strategic value of coordinated external engagement to senior executive leadership. + Motivated and solution-oriented, with a clear focus on simplifying complex processes for end-users. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$183.3k yearly 38d ago
Global Clinical Program Lead, CVRM
Astrazeneca 4.6
Gaithersburg, MD jobs
At the cutting-edge of science, AstraZeneca is a place to rethink the future of medicine. For the industry, ourselves, and patients. Work on ground-breaking medicine development and be at the forefront of answering some of the most complex unmet patient needs. As a Global Clinical Program Lead, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. The successful GCPL in Late Phase CVRM will be responsible for the design, conduct, monitoring, data interpretation and reporting of clinical trials ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as allow for the intended label indication in markets globally. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements. What you will do: Medical expert accountabilities Provide strategic medical and scientific knowledge and support the design, initiation, execution, completion, and interpretation of a clinical study Be accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites Trial conduct and hands-on delivery accountabilities Accountable to the Global Clinical Head or delegate for the medical aspects and designs of studies Responsible for driving decisions within Study Team remits together with members and for solving medical issues in the study team Accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP Accountable for delivery of the clinical components of all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans) Accountable for ensuring that safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting, the querying of missing/unclear data, the review of blinded safety data, and the escalation to the GCH/Global Safety Physician when needed. Medically accountable for international investigator meetings, and supports Marketing Companies in national activities Approve (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion). Messaging and external impact accountabilities Maintain a high degree of understanding and awareness on new and emerging medical development, globally. Work with international colleagues and with external Alliance partners on development initiatives and regulatory issues Apply strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products Provide guidance for investigator-initiated trials in cooperation with regional marketing companies Basic Qualifications Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree, and/or a graduate of a scientific doctorate (e.g. PhD or PharmD) in a scientific discipline or Pharmaceutical Medicine 3+ years clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results Good knowledge of biostatistics, global regulatory environment and pharmacovigilance Demonstrated partnership and collaboration skills, including acting as the leader and clearly communicating across countries and cultures Strong presentation skills and effective communication Desired Experience: Good general medical knowledge preferably in cardiology or metabolic disease. Preferably 3-5 years in the pharmaceutical industry, with an understanding of R&D, particularly of major clinical milestones and of the factors which influence drug development The annual base salary for this position ranges from $280,895 - $421,342. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Date Posted 14-Jan-2026 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
$106k-134k yearly est. Auto-Apply 9d ago
Senior Manager, External Engagement Strategic Planning
Otsuka America Pharmaceutical Inc. 4.9
Annapolis, MD jobs
The Senior Manager, External Engagement Strategic Planning will play a critical role in shaping and executing strategic initiatives that enhance the impact of Medical Affairs external stakeholder engagement activities (including those of the managed market liaison (MML) team). This role will lead cross-functional planning efforts, develop frameworks for scientific exchange and stakeholder engagement, while ensuring alignment with global and US medical strategies and business objectives. **** **Key Responsibilities Include:** **Strategic Planning & Execution** + Lead the development and implementation of strategic plans for external engagement across therapeutic areas + Collaborate with global and US Medical Affairs teams to ensure alignment with scientific and commercial priorities + Offer strategic planning support, analytics tools, and guidance on process excellence techniques for External Engagement & Field Excellence, as well as MML teams + Drive the development of annual and long-range strategic plans for the MML team, including goal setting, performance metrics, and resource planning with Strategic Planning Lead oversight + Drive the integration of insights from field medical teams into strategic planning processes **External Engagement Strategy** + Design and optimize engagement models for key external stakeholders including healthcare professionals (HCPs), scientific experts, and advocacy groups + Develop metrics and KPIs to assess the effectiveness of external engagement activities. + Partner with Compliance and Legal to ensure all engagement strategies meet regulatory and ethical standards. **Cross-Functional Collaboration** + Work close with Medical Excellence and Operations team to facilitate cross-functional workshops and planning sessions to align on stakeholder engagement priorities **Operational Excellence** + Oversee the development of tools, resources, and training programs to support MML effectiveness and strategic engagement + Contribute to the development of governance models and operational processes that support compliant and coordinated external engagement + Lead initiatives to improve data capture, insight generation, and reporting from field medical teams and MML team + Manage budgets and timelines for strategic planning initiatives + Prepare executive-level presentations, dashboards, and reports to communicate progress, insights, and recommendations to senior leadership **Qualifications** **Education and Experience:** + Bachelors degree required, advanced degree in life sciences (PharmD, PhD, MD, or equivalent) preferred + 7+ years of experience in Medical Affairs, Field Medical, Market Access, or related functions within the pharmaceutical or biotech industry **Skills and Competencies:** + Ability to work effectively within cross-functional teams and in an environment of rapid change + Proven experience in strategic planning, field medical operations, or external stakeholder engagement + Strong understanding of compliance and regulatory requirements in medical engagement + Strong understanding of the U.S. & Global healthcare landscape, including payer and policy environments + Excellent communication, leadership, and project management skills + Strong understanding of pharmaceutical compliance and regulatory frameworks + Excellent communication and interpersonal skills, with the ability to influence cross-functional teams + Strong analytical and problem-solving skills to address complex challenges within medical affairs + Experience with digital engagement platforms and data analytics tools + Familiarity with global medical affairs operations and regional nuances + Strategic mindset with a passion for innovation and continuous improvement **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$147k yearly 60d+ ago
Senior Manager National Systems Training
Otsuka America Pharmaceutical Inc. 4.9
Annapolis, MD jobs
The Field Force Effectiveness team at Otsuka America Pharmaceutical, Inc. plays a highly visible role in optimizing the performance of the sales and marketing efforts, for the field sales teams. As a result, Systems Training plays a key role in ensuring that the sales force understands how to effectively utilize our technology to enhance customer interactions, optimize selling opportunities and provide insight on our business processes that support our business. The Senior Manager of National Systems Training work with the field sales teams to design, develop and deliver new hire systems tech training on our InGenius (CRM System), ORION (Field Reporting) and Business Planning system across all brands. The role is also responsible or continual training on system enhancements and capabilities for the organization. In addition, the role will require system training content updates and cross collaboration between systems owners and multiple departments such as compliance, operations, IT, sales leadership, and marketing partners. The Senior Manager of National Systems Training will report to the Director, of Marketing and Sales Technologies and partner closely Training & Development & Home Office functions. In addition, the role will work with our internal Field Force Effectiveness points to identify user experience improvements and capabilities that better support a seamless customer interaction in the field. **Core Responsibilities:** + New Hire system training CRM, Field Reporting and Business Planning across all commercial sales teams + Responsible for developing and updating training materials and curriculum to reflect system enhancements + Provide ongoing training on system enhancements to support the field sales teams + Coordinate with Field Training and Development teams on New Hire Training content and agenda + Identify key user experience insights and ongoing system training opportunities collected from field ride observations + Incorporate business processes education in training sessions to support Otsuka's ways of working + Work closely with the Field Force Effectiveness team to identify user experience improvements + Partner with system owners to design training content to support enhancements and new capabilities + Develop pull through strategies to support ongoing system and business process learnings for the field. Such as Specialty Attestation, Customer Affiliations, Precall and Post Call Planning, Field Reporting Insights etc. + Work closely with cross-functional teams and stakeholders to define training needs and requirements **Qualifications:** Required + Bachelor's degree: MBA or other related graduate degree preferred + Ability to communicate technical information in a way that is easy to understand for the field and effectively identify key selling opportunities + Strong command of CRM, Field Reporting and Business Planning systems and the ability to train on them + Previous experience in a Region or Ecosystem point role that supports training and coaching field team members + Ability to work in an ambiguous environment undergoing transformation + Excellent communication, collaboration, facilitation, and presentation skills + Possess a growth mindset that is open to development & coaching and willing to challenge the statue quo + Proven track record for consistently meeting or exceeding performance goals + Understands and articulates healthcare compliance, legal and regulatory landscape + Technical acumen and understanding the backend systems + Experience selecting and managing training vendors + Abilify to create content in PowerPoint or other tools Preferred + Previous experience in a field leadership or coaching role that supports business acumen development of the sales team members + Experience as a training in the pharmaceutical industry + Understanding of principles of instructional design and adult learning theory + Experience with putting material through the Promotional, Regulatory and Compliance Review Process **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.
$150k yearly 14d ago
Engager
Lucid Hearing 3.8
Annapolis, MD jobs
Our Mission: "Helping People Hear Better" Lucid Hearing is a leading innovator in the field of assistive listening and hearing solutions, and it has established itself as a premier manufacturer and retailer of hearing solutions with its state-of-the-art hearing aids, testing equipment, and a vast network of locations within large retail chains. As a fast-growing business in an expanding industry, Lucid Hearing is constantly searching for passionate people to work within our amazing organization. Club: Sam's Club in Annapolis, MD Hours: Full time/ Tuesday-Saturday 9am-6pm Pay: $18-$19/hr What you will be doing: • Share our passion of giving the gift of hearing by locating people who need hearing help • Directing members to our hearing aid center inside the store • Interacting with Patients to set them up for hearing tests and hearing aid purchases • Secure a minimum of 4 immediate or scheduled full hearing tests daily for the hearing aid specialist or audiologist that works in the center • 30-50 outbound calls daily. • Promote all Lucid Hearing products to members with whom they engage. • Educate members on all of products (non hearing aid and hearing aid) when interacting with them • Assist Providers when necessary, calling past tested Members, medical referrals to schedule return, etc. What are the perks and benefits of working with Lucid Hearing: Medical, Dental, Vision, & Supplemental Insurance Benefits Company Paid Life Insurance Paid Time Off and Company Paid Holidays 401(k) Plan and Employer Matching Continual Professional Development Career Growth Opportunities to Become a LEADER Associate Product Discounts Qualifications Who you are: Willingness to learn and grow within our organization Sales experience preferred Stellar Communication skills Business Development savvy Appointment scheduling experience preferred A passion for educating patients with hearing loss Must be highly energetic and outgoing (a real people person) Be comfortable standing multiple hours Additional Information We are an Equal Employment Opportunity Employer.
$18-19 hourly 3d ago

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Updated January 22, 2026

Senior Manager jobs at U.S. Pharmacopeia - 133 jobs

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Engager

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