Management consultant jobs in Corvallis, OR - 151 jobs

We are from US IT Solutions, an ISO Certified, E-Verify, WMBE Certified organization established in 2005 in CA. Our company is serving various State, Local and County Departments for over 10 years. USITSOL has been helping clients innovate across all phases of the application lifecycle for over a decade. Some of our prestigious clients are State of CA, State of OR, State of FL, State of NC, State of GA, State of CO, State of VA, State of AR, State of MI, State of OH, State of IL, State of MO, State of MS, California State University, Sacramento Area Sanitation Department, SMUD, Sound Transit, LA Superior Courts, District of Columbia, UMAS, University of Central Florida and Hennepin County and many more. Job Description Title: Biz Apps Dockets and Discovery Business Process Mapping Duration 7 Months Location Salem, OR Short Description: Client is replacing a custom developed docketing system, Biz Apps. Before the replacement project can take place, they want to map out our current-state business process and create a functional requirements document. The replacement project is budgeted for the 2017-2019 biennium. This means the replacement project has to be completed by 6/30/2019. In order to allocate as much time as possible for the replacement project, the current-state business process mapping and functional requirements documentation need to be completed right away. Additional Information Able to work with many programming tools such as; People Tools, People Code, Integration Broker, Component Interface, SQR, SQL, PS Query, Application Engine, XML Publisher, BPEL, and other programming tools.

**Who Are We?** Taking care of our customers, our communities and each other. That's the Travelers Promise. By honoring this commitment, we have maintained our reputation as one of the best property casualty insurers in the industry for over 170 years. Join us to discover a culture that is rooted in innovation and thrives on collaboration. Imagine loving what you do and where you do it. **Job Category** Corporate Services/Other, Finance and Accounting, Operations **Compensation Overview** The annual base salary range provided for this position is a nationwide market range and represents a broad range of salaries for this role across the country. The actual salary for this position will be determined by a number of factors, including the scope, complexity and location of the role; the skills, education, training, credentials and experience of the candidate; and other conditions of employment. As part of our comprehensive compensation and benefits program, employees are also eligible for performance-based cash incentive awards. **Salary Range** $70,000.00 - $70,000.00 **Target Openings** 1 **What Is the Opportunity?** The Performance Construction Advisors (PCA) is a wholly-owned subsidiary of Travelers. PCA facilitates executive peer groups which are exclusive gatherings of seven to ten CEOs where, with the assistance of a professional facilitator, non-competing leaders openly review their companies and share information in a focused effort to build breakthrough success for themselves, their families, their employees, and their customers. In addition, PCA offers consulting services that help family-owned and other closely held business owners and leaders make more money in less time with fewer headaches with a higher quality of life. Acting as a Peer Group Facilitator and Senior Consultant, the Business Consultant facilitates meetings of closely held business CEOs and executives and delivers one-on-one consulting services as assigned. The successful candidate will possess considerable business experience broadly applicable to executing PCA's peer group facilitation and one-on-one consulting programs while also having latitude to creatively address client needs. This is a fully-Commissioned role. Employees in this role will be paid a draw of $70,000 and have the opportunity to earn the majority of their pay through commission payments. **What Will You Do?** + Develop relationships and facilitate peer group meetings of commercial construction CEOs and executives. + Collect and analyze financials of peer group members. + Work closely with peer group host companies in preparation for peer group meetings. + Coordinate with other PCA staff for meeting preparation, logistics, and follow-through. + Conduct peer group meetings on time, on task, and with exceptional quality. + Hold peer group members accountable for follow-through on group recommendations. + Deliver limited one-on-one consulting to peer group members to assist in goal attainment. + Actively seek one-on-one consulting opportunities within the assigned peer groups. + Deliver additional one-on-one consulting as assigned. + Follow PCA's established processes and best practices for peer group facilitation and one-on-one consulting - and contribute to the continuous improvement of these processes and practices. + Maintain accurate member/client records. + Coordinate closely with other functions to maximize member experience and lifetime value. + Provide input into developing and maintaining the peer group program operations manual. + Perform other duties as assigned. **What Will Our Ideal Candidate Have?** + 5 years experience consulting with closely held business owners. + Experience owning or operating a commercial construction business. + Proactive, entrepreneurial approach to recognizing needs, solving problems, anticipating issues and developing solutions. + Demonstrable delivery of high quality work/service within agreed upon timeframes. + Able to communicate as a peer to highly successful, strong-willed CEO members. + Equally exceptional team and individual performer. + Helpful and highly responsive. + Strong problem solving ability. + Strong organizational skills. + Strong, articulate communication skills. + Entrepreneurial. + Proficient in Microsoft Office (Word, Excel, PowerPoint, and Outlook). + Capable and comfortable with web-based applications integrated into PCA's established processes and best practices. **What is a Must Have?** + Bachelor's degree required. + 10 years of business experience required. + Ability to travel up to 75% of the time required. **What Is in It for You?** + **Health Insurance** : Employees and their eligible family members - including spouses, domestic partners, and children - are eligible for coverage from the first day of employment. + **Retirement:** Travelers matches your 401(k) contributions dollar-for-dollar up to your first 5% of eligible pay, subject to an annual maximum. If you have student loan debt, you can enroll in the Paying it Forward Savings Program. When you make a payment toward your student loan, Travelers will make an annual contribution into your 401(k) account. You are also eligible for a Pension Plan that is 100% funded by Travelers. + **Paid Time Off:** Start your career at Travelers with a minimum of 20 days Paid Time Off annually, plus nine paid company Holidays. + **Wellness Program:** The Travelers wellness program is comprised of tools, discounts and resources that empower you to achieve your wellness goals and caregiving needs. In addition, our mental health program provides access to free professional counseling services, health coaching and other resources to support your daily life needs. + **Volunteer Encouragement:** We have a deep commitment to the communities we serve and encourage our employees to get involved. Travelers has a Matching Gift and Volunteer Rewards program that enables you to give back to the charity of your choice. **Employment Practices** Travelers is an equal opportunity employer. We value the unique abilities and talents each individual brings to our organization and recognize that we benefit in numerous ways from our differences. In accordance with local law, candidates seeking employment in Colorado are not required to disclose dates of attendance at or graduation from educational institutions. If you are a candidate and have specific questions regarding the physical requirements of this role, please send us an email (*******************) so we may assist you. Travelers reserves the right to fill this position at a level above or below the level included in this posting. To learn more about our comprehensive benefit programs please visit ******************************************************** .

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Job Description We are looking to fill a position for PMP certified project manager in Salem OR. · This position will perform risk management, schedule management, and budget management functions. Position requires excellent communication skills, ability to adhere to strict timelines and follow directions. · Responsible for the coordination and completion of projects. · Oversees all aspects of projects. Sets deadlines, assigns responsibilities, and monitors and summarizes progress of project. · Prepares reports for upper management regarding status of project. Qualifications · May require a bachelor's degree and at least four years or equivalent of experience in the field or in a related area. · At least 4 years of experience as a Project manager · Experience with MS Office is required. Additional Information Webcam interview is acceptable.

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.

**Candidates must be local or willing to commute or relocate, Candidate must be within 50 miles. Description Individuals with successful project management experience limited to projects of small scope, limited risk and complexity and/or of short duration. Individuals at this level will typically be assigned to manage projects under the direction of a state supervisor or manager. Individuals with this level of experience are suitable for small Client Agency projects with clear, achievable outcomes, or in assignment as project support on larger projects. Individuals at this level can also be used in the capacity of a Project Controller, provided that they can satisfy the basic requirements of that position. Advanced level: Individuals with a mastery of project management skills, qualifications and experience. This individual shall function effectively with very little supervision, while maintaining a high professional standard. They are assigned to extremely complex and/or high -risk projects that reflect the highest priorities of state government. These individuals are comfortable working with the highest levels of state government and are able to contribute to the furtherance of the states' objectives. These individuals have the necessary skills and experience to assist in statewide project portfolio management and/or IT Investment Management. Apply project management principles and techniques as defined in the Project Management Body of Knowledge (PMBOK). Manage project budgets, schedules, timelines as well as report on progress and status deliverables. Full responsibility for scope management, configuration management, including change control issues logs, testing, verification, and validation of new systems. Coordination and oversight of all project resources, including IS technical staff, customers, and contract personnel. Ensure adherence to project management, development, testing, and documentation standards of the ISD division. Coordinate the implementation of applications with the assigned LSA. Manage resource allocation and project team capacity to ensure project work is accomplished. Project communications, regular “stand up” project meetings, and coordination with the Configuration Management Specialist and Database Administrator. Control and monitor all out -sourced tasks. Requirements BenefitsFor Full time employment on W2, the benefits include 2 weeks' vacation, and 1 week's sick leave and 50% covered the health insurance Premium.

GE Aerospace's US Pay & Time Center of Excellence (COE) is a team of dedicated specialists focused on delivering accurate and timely payroll and time & attendance services for exempt and non-exempt employee populations. The team ensures seamless integration and alignment of payroll and time & attendance processes with broader organizational goals, establishing standard work and governance to leverage best practices and support the successful preparation, processing, and documentation of payroll. The US Senior Pay & Time Manager role is a critical leadership position responsible for overseeing a team of payroll and time & attendance specialists supporting exempt and non-exempt US employee populations across multiple sites and business units. This role drives sets direction and drives strategic initiatives to ensure timely, accurate, and compliant payroll processing, enabling employees to focus on delivering excellence in safety, quality, delivery, and cost (SQDC). As a key partner to site leaders and senior stakeholders, the US Senior Pay & Time Manager fosters strong connections across the organization, ensuring alignment with business priorities while using Flight Deck to implement process improvements, standardization, simplification, and operational efficiency. This role leverages best practices from across GE Aerospace and external benchmarks, guiding leaders and the team in creating innovative solutions to enhance payroll systems and practices. This role requires a forward-thinking approach to payroll operations, combining deep technical expertise with strategic leadership to deliver exceptional service and continuous improvement. This role partners closely with HR Managers, Business Leaders, Digital Technology, and other People Operations teams, acting as a liaison across these functions to drive process improvements, enhance system functionality, and ensure compliance with federal, state, and local regulations. You will influence strategy and priorities across sites and programs, ensuring consistent execution and measurable impact on SQDC. As a US Senior Pay & Time Manager, you will be responsible for leading the compliance, productivity and efficiency of the essential service and process delivery of payroll and time & attendance functions. You will provide strategic direction and insight on continuous improvement solutions to evolve and enhance payroll and time & attendance processes and systems, and you will build leadership capability to sustain results. Additionally you will be responsible for serving as a peer mentor to other team leaders in the NAM organization. **Job Description** **Essential Responsibilities:** + Ensuring pay is processed on time, accurately and in compliance with government regulations. + Leading a high-performing team, developing the team's technical proficiency, making training and development opportunities available and achievable. + Partner with others such as site leaders, vendors, HR Partners, Total Rewards, and People Ops teams on compliant and sustainable design, implementation, and governance of pay practices, resolving complex escalations and risk. + Manage the partnership with Digital Technology and time and attendance application support to provide feedback and direction on the time and attendance system road map & strategy, and partner on implementation and maintenance. + Drive process improvements and implement strategic initiatives. + Resolving complex escalations and risk, explaining complex payroll concepts to a range of employee personas from executives to HR to production employees in a clear and approachable manner. + Implement standard work for pay & time processes & procedures. + Building strong cross-functional relationships and executive stakeholder management; aligning objectives and resources across functions; surfacing risks with mitigation plans. + Analyzing payroll data and metrics to identify trends and opportunities for improvement, leading root cause analysis; translating insights into action plans with measurable outcomes. + Managing over/underpayment processes and partnership with HR and Union Relations / Employee Relations teams to ensure appropriate action. + Provide insight on team strategy and continuous improvement solutions. + Identifying opportunities and pain points, offering solution design options to improve payroll and time & attendance processes. + Providing payroll and time & attendance expertise and leadership during M&A activities. + Translating strategies into action plans and align team priorities to the business. + Obtaining certification in either Workday, Time System or Payroll within one year in role to ensure appropriate level of technical leadership for role. + Serve as a peer mentor to other team leaders in NAM organization. **Qualifications/ Requirements:** + Bachelor's degree in Business Administration, Finance, Human Resources, or a related field from an accredited university with minimum of 5 years of experience in HR Function and/or Payroll/Time & Attendance area, or a high school diploma / GED with at least 9 years of experience in HR Function and/or Payroll/Time & Attendance area. + Expertise in Workday Payroll, time & attendance systems and integration with payroll processes. + Strong knowledge of federal, state, and local payroll regulations, including FLSA, tax compliance and reporting. + Willing to travel as needed up to 15%. **Desired Characteristics:** + Certified Payroll Professional (CPP), Fundamental Payroll Certification (FPC), Workday, or time system certification. + Strong problem-solving skills to address complex payroll challenges. + Excellent executive communication and stakeholder management skills; ability to engage employees, leaders, and external partners. + Willingness to deep dive into current time and attendance site practices and develop strategy and execute resulting in standardization of work across sites. + Serve as a role model continuous improvement behaviors needed to encourage and embed change. + Strong interpersonal and leadership skills. + Strong problem solving and troubleshooting skills; solutions-oriented approach + Experience in managing internal & external audits. + Ability to manage and prioritize multiple urgent deliverables; experience in a matrixed leadership environment. + Experience with managing people virtually or a geographical dispersed team. **Pay and Benefits:** + The base pay range for this position is $117,000 - 160,000. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on November 7th, 2025. + GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** No \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Norstella is a premier and critical global life sciences data and AI solutions provider dedicated to improving patient access to life-saving therapies. Norstella supports pharmaceutical and biotech companies across the full drug development lifecycle - from pipeline to patient. Our mission is simple: to help our clients bring therapies to market faster and more efficiently, ultimately impacting patient lives. Norstella unites market-leading brands - Citeline, Evaluate, MMIT, Panalgo, Skipta and The Dedham Group and delivers must-have answers and insights, leveraging AI, for critical strategic, clinical, and commercial decision-making. We help our clients: + Accelerate the drug development cycle + Assess competition and bring the right drugs to market + Make data driven commercial and financial decisions + Match and recruit patients for clinical trials + Identify and address barriers to therapies Norstella serves most pharmaceutical and biotech companies around the world, along with regulators like the FDA, and payers. By providing critical proprietary data supporting AI-driven workflows, Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient, innovative, and responsive to patient needs. **The Role: Senior RWD Analytic Consultant** We are currently seeking a high energy, motivated and passionate expert in RWD and the pharmaceutical industry to join our RWD Engagement Team as a RWD Senior Analytic Consultant to support our delivery of RWD engagements across the life sciences industry. The ideal candidate will be passionate about sleuthing through RWD to unpack insights and answers to some of the most challenging business problems our clients face. This role's creation is in reaction to the demand for Norstella's newest service offerings leveraging Norstella's unified Real World Data asset, NorstellaLinQ, a combination of claims, lab, SDOH and EMR data. You will be joining an organization hard wired for innovation and specialization to meet the high demands of our biopharmaceutical and life sciences client base. You will join a high-performing team empowered to work creatively to deliver solutions that enable patients to access therapies they need. This role requires a combination of business acumen, analytical, technical, and commercial expertise to effectively deliver Norstella's RWD solutions. Our RWD offerings include cutting-edge data solutions and expert advisory services alongside advanced technologies such as real-world data, machine learning and predictive analytics. It is critical that an individual in this role has worked in and understands the dynamics of the US healthcare ecosystem. **Responsibilities:** - Lead the delivery of complex RWD engagements across the life sciences industry, leveraging Norstella's unified Real World Data asset. - Design and implement advanced SQL queries to extract, clean, and analyze data from large relational databases, ensuring data accuracy and quality. - Perform in-depth analyses on healthcare data sources, including claims, lab, EMR/EHR, and SDOH data, to uncover actionable insights and drive evidence-based decision-making. - Serve as the strategic advisor to clients, guiding them through nuanced challenges by providing actionable insights derived from RWD. - Take ownership of large-scale analytical projects, ensuring alignment with business goals and client expectations. - Mentor consultants, fostering a high-performance culture. - Actively contribute to the development and enhancement of Norstella's RWD offerings by integrating innovative techniques such as advanced predictive analytics. - Represent Norstella in key client interactions, presenting findings and driving discussions at the executive level. **Qualifications:** - 4+ years of professional experience working hands on with RWD (e.g., open/closed claims, APLD, lab, EMR/EHR, hospital chargemaster, billing codes, etc.) - Advanced understanding of the life sciences industry and the US healthcare ecosystem. - Proven track record of successfully delivering client-facing projects and managing stakeholder expectations. - Expertise in SQL and advanced data analysis, with experience in predictive modeling and machine learning a plus. - Exceptional leadership and team management skills, with a strong ability to mentor and inspire. - Entrepreneurial mindset with demonstrated creativity in problem-solving and strategic thinking. **Our Guiding Principles for success at Norstella:** 01: Bold, Passionate, and Mission-First 02: Integrity, Truth, and Reality 03: Kindness, Empathy, and Grace 04: Resilience, Mettle, and Perseverance 05: Humility, Gratitude, and Learning **Benefits:** - Medical and Prescription Drug Benefits - Health Savings Accounts (HSA) or Flexible Spending Accounts (FSA) - Dental & Vision Benefits - Basic Life and AD&D Benefits - 401k Retirement Plan with Company Match - Company Paid Short & Long-Term Disability - Paid Parental Leave - Paid Time Off & Company Holidays **Please Note - All candidates must be authorized to work in the United States. We do not provide visa sponsorship or transfers. We are not currently accepting candidates who are on an OPT visa.** _The expected base salary for this position ranges from $130,000 to $140,000. It is not typical for offers to be made at or near the top of the range. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, licensure or certifications obtained. Market and organizational factors are also considered. In addition to base salary and a competitive benefits package, successful candidates are eligible to receive a discretionary bonus._ _Norstella is an equal opportunity employer. All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law._ _Sometimes the best opportunities are hidden by self-doubt. We disqualify ourselves before we have the opportunity to be considered. Regardless of where you came from, how you identify, or the path that led you here- you are welcome. If you read this job description and feel passion and excitement, we're just as excited about you._ _All legitimate roles with Norstella will be posted on Norstella's job board which is located at norstella.com/careers. If a role is not posted on this job board, a candidate should assume the role is not a legitimate role with Norstella. Norstella is not responsible for an application that may be submitted by or through a third-party and candidates should proceed with extreme caution if a third-party approaches them about an open role with Norstella. Norstella will never ask for anything of value or any type of payment during or as part of any recruitment, interview, or pre-hire onboarding process. If you are aware of or have reason to believe a job posting purportedly for a role with Norstella is fraudulent or otherwise not authorized by Norstella, please contact the Company using the following email address:_ _[email protected]_ Norstella is an equal opportunity employer. All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law.

Site: North Shore Medical Center, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary The Senior Manager in this role will oversee the execution of MGB strategy, processes, and infrastructure for the domains of safety, risk and PFR. This role oversees a team of safety, risk, and PFR specialists to support the implementation of standardization of best practices and a system strategy. This role will collaborate with site leadership to execute long and short-term goals for Risk Management, Patient Safety programs, and Patient and Family Relations. Does this position require Patient Care? No Essential Functions Support the build out of safety/risk/PFR infrastructure, ensuring standardization in training, processes, and safety responses that are in line with MGB. * Executes the MGB safety plans including those around event analysis, safety event reporting/management/mitigation. * Implement the standardized risk management strategy, policies, and procedures, ensuring that risk management activities both align to and augment our approach to patient safety. * Implement the system-wide safety event reporting system. * Support as needed for system wide safety events such as recalls, shortages, and other events that impact safety. * Understand data provided by the system team and use knowledge of local practices to identify areas of opportunity for improvement of patient safety as well as communicate to the system areas that are at risk. Qualifications Education Bachelor's Degree Related Field of Study required or Bachelor's Degree Patient Safety Leadership required and Master's Degree Nursing preferred Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience * Must have clinical background or medical malpractice or legal background Safety, Risk Management, and patient family relations. 3-5 years required and Leading process improvement and initiatives * Leadership and Managing teams. 3-5 years required Knowledge, Skills and Abilities * Support the build out of safety/risk/PFR infrastructure, ensuring standardization in training, processes, and safety responses that are in line with MGB. * Executes the MGB safety plans including those around event analysis, safety event reporting/management/mitigation. * Implement the standardized risk management strategy, policies, and procedures, ensuring that risk management activities both align to and augment our approach to patient safety. * Implement the system-wide safety event reporting system. * Support as needed for system wide safety events such as recalls, shortages, and other events that impact safety. * Understand data provided by the system team and use knowledge of local practices to identify areas of opportunity for improvement of patient safety as well as communicate to the system areas that are at risk. Additional Job Details (if applicable) Physical RequirementsStanding Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Hybrid Work Location 81 Highland Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $97,510.40 - $141,804.00/Annual Grade 8 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: North Shore Medical Center, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Title of Role: Senior Manager Regulatory Affairs Department: Quality East West Tea is seeking a talented, passionate, and experienced Senior Manager Regulatory Affairs to join our Quality team! The Senior Manager Regulatory Affairs will review product formulations, labels, claims substantiations, develop Yogi's regulatory framework, and support cross-functional teams with expert regulatory guidance. Working with external legal counsel to ensure compliance and maximize commercial effectiveness. Utilizing knowledge of the Regulatory and Legal environment in USA and Canada (21 CFR part 101, 111, 7 CFR Part 205 and Natural Health Products Regulations) to ensure our products are compliant within a changing market as we maintain our portfolio and innovate in hot tea, concentrates and other new categories. Your ability to think strategically, create solutions and communicate effectively to diverse teams will be key to success in this role. WHO WE ARE: We are the well-being company that exists to inspire and enhance everyday life through trust and good will. Our guiding principles, beliefs, and philosophies shape our identity. They are the essence of our culture and define how we do what we do. We are Intentional - we chose to lead with positive intent. Mindful - we are present and aware of how we show up in the world. People - we value and respect all people and communities. Authentic - we are real and transparent with everything we do. Committed - we are committed to quality products while sustaining our planet. Trust - we consistently align our words with our actions. OUR INVESTMENT IN YOU: We have exceptional wellbeing-focused benefits including health, dental, vision and alternative care, life and disability insurance, retirement, paid time off, company picnics, social activities, and a surprise every so often! Who doesn't love a surprise? This position has a preference to be located in Eugene, Oregon, will consider remote. As a certified B Corp, we're a company that lives our values every day. We work in a LEED certified facility which prioritizes the planet in our daily operations and optimizes our employee experience while at work. We prioritize sustainability as a business by embedding it into our values, our strategic priorities, our decision-making, and our resource allocations. Our Nourish Market provides employees subsidized healthy lunch and snack options. We commit to our purpose in every aspect of our culture. We have employees that are committed to “Doing Good” in our community and around the world. We are a growing company with products that customers love. We believe in investing in you and your growth and development. WHAT YOU'LL OWN: Content Review and Compliance 50% of time Review and approve product formulations, labels, and claims for compliance with 21 CFR 101, 21 CFR 111, USP 561, 7 CFR Part 205, US FDA/DSHEA and other applicable regulations and have a working knowledge of international regulations (e.g., NHP SOR/2003-196) Create, lead and collaborate on claims substantiation process to ensure ingredient usage, nutritional limits and health claims are aligned with country-specific regulatory requirements Lead cross functional teams through optimization of label/content review processes to assess potential impact on the company's product portfolio and advise on risk mitigation strategies Oversee regulatory monitoring and horizon activities- review and analyze the new and emerging regulations and trends from government agencies that affect the company Ensure that information concerning such regulations and requirements, especially new or modified, is distributed to appropriate decision makers Strategic Responsibilities 20% of time Support to Brand, R&D for innovation and Renovation Product Development including ingredient status, permissible limits, and labeling requirements to ensure product concepts are regulatory-compliant from the early stages of development Track and analyze draft regulations, standards, and global regulatory trends Lead relationship management on behalf of the company with appropriate regulatory agencies (FDA, QAI, Health Canada) and customers (for regulatory matters) ensuring strong collaborative partnerships Operational Responsibilities 30% of time Key relationship manager for external certifying partners Develop, monitor, and report on Key Deliverables in regulatory affairs (e.g., adverse events and significant adverse events) Provide leadership as an engaged business partner between key stakeholders (QA, R&D, Sales, Marketing, Consumer Affairs, Operations) to ensure questions and questionnaires and other communications are completed to ensure speed to market WHAT YOU KNOW AND HAVE EXPERIENCED: Bachelor's or Masters in Science, Food Science, Nutrition, or related field 10+ years of experience in regulatory affairs within food and supplements (experience in both required) in FMCG/CPG Strong understanding of applicable US regulations (not limited to 21 CFR 111, USP 561, 7 CFR Part 205, US FDA/DSHEA, Prop 65 and AB 347 in California) Professional experience with claims substantiations in supplements and food Experience in handling product registrations and compliance for Health Canada preferred YOU'LL BE A GREAT FIT: Strong critical thinking ability to navigate and solve complex problems Solid work ethic, self-starter, and result-oriented Natural ability to develop strong, trusting relationships Enjoys collaborating with cross-functional partners Responsible and a high degree of ownership Thrives in an ever-changing work environment Effectively managing a multitude of work responsibilities Balances attention to detail and swift execution

At American Express, our culture is built on a 175-year history of innovation, shared values and Leadership Behaviors, and an unwavering commitment to back our customers, communities, and colleagues. As part of Team Amex, you'll experience this powerful backing with comprehensive support for your holistic well-being and many opportunities to learn new skills, develop as a leader, and grow your career. Here, your voice and ideas matter, your work makes an impact, and together, you will help us define the future of American Express. **How will you make an impact in this role?** + Advance adoption of Amex debit capabilities + Manage processing partner relationships, integrations, and compliance; regularly engage with external partners on debit + Develop thorough documentation and operationally sustainable processes to ensure consistent results + Negotiate complex contracts with partners and customers + Create and expand relationships with key external debit partners + Develop technical proficiency and requisite fluency with network capabilities, including connectivity, specifications, and processes + Collaborate broadly, sharing roadmap and interoperability considerations, and thought-leadership regarding U.S. debit norms + Build strong positive relationships within Amex, including network, issuing, legal, pricing, policy, technology, and relationship management teams + Maintain deep and current knowledge about the payment services industry, debit and U.S. market trends, new and existing technologies, products, and services **Minimum Qualifications:** + Minimum 3 years' experience in the processing and acquiring of U.S. debit cards with processor, debit network, or acquirer + Sound technical aptitude, analytical, and problem-solving skills + Demonstrated ability to guide, contribute to, and execute on strategies to deliver outcomes aligned to business goals in matrixed organizations + Experience negotiating complex contracts with partners and/or customers + Proven ability to build, maintain, and leverage strong relationships with internal and external stakeholders, including industry partners + Track record of leading through change, challenging the status quo, and leading and producing results with or without authority + Excellent communication and interpersonal skills with the ability to articulate and illustrate complex issues in a simple, non-technical manner + Strong work ethic and organizational skills, with high level of intellectual curiosity, initiative, drive, and attention to detail + Potential travel required within U.S. (~10%) + Bachelor's degree or equivalent industry experience required. **Preferred Qualifications:** + Expansive and active network across payments industry. **Qualifications** Salary Range: $103,750.00 to $174,750.00 annually bonus benefits The above represents the expected salary range for this job requisition. Ultimately, in determining your pay, we'll consider your location, experience, and other job-related factors. We back you with benefits that support your holistic well-being so you can be and deliver your best. This means caring for you and your loved ones' physical, financial, and mental health, as well as providing the flexibility you need to thrive personally and professionally: + Competitive base salaries + Bonus incentives + 6% Company Match on retirement savings plan + Free financial coaching and financial well-being support + Comprehensive medical, dental, vision, life insurance, and disability benefits + Flexible working model with hybrid, onsite or virtual arrangements depending on role and business need + 20 weeks paid parental leave for all parents, regardless of gender, offered for pregnancy, adoption or surrogacy + Free access to global on-site wellness centers staffed with nurses and doctors (depending on location) + Free and confidential counseling support through our Healthy Minds program + Career development and training opportunities For a full list of Team Amex benefits, visit our Colleague Benefits Site . American Express is an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other status protected by law. American Express will consider for employment all qualified applicants, including those with arrest or conviction records, in accordance with the requirements of applicable state and local laws, including, but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For positions covered by federal and/or state banking regulations, American Express will comply with such regulations as it relates to the consideration of applicants with criminal convictions. We back our colleagues with the support they need to thrive, professionally and personally. That's why we have Amex Flex, our enterprise working model that provides greater flexibility to colleagues while ensuring we preserve the important aspects of our unique in-person culture. Depending on role and business needs, colleagues will either work onsite, in a hybrid model (combination of in-office and virtual days) or fully virtually. US Job Seekers - Click to view the " Know Your Rights " poster. If the link does not work, you may access the poster by copying and pasting the following URL in a new browser window: *************************** Employment eligibility to work with American Express in the United States is required as the company will not pursue visa sponsorship for these positions. **Job:** Network **Primary Location:** United States **Other Locations:** US-Arizona-Phoenix, US-New York-New York **Schedule** Full-time **Req ID:** 25021234

Cardinal Health Sonexus Access and Patient Support helps specialty pharmaceutical manufacturers remove barriers to care so that patients can access, afford, and remain on the therapy they need for a better quality of life. Our diverse expertise in pharma, payer, and hub services allows us to deliver best-in-class solutions-driving brand and patient markers of success. We're continuously integrating advanced and emerging technologies to streamline patient onboarding, qualification and adherence. Our non-commercial specialty pharmacy is centralized at our custom-designed facility outside of Dallas, Texas, empowering manufacturers to rethink the reach and impact of their products. Together, we can get life-changing therapies for patients who need them-faster. **Job Summary** Datahub is responsible for sending and receiving PHI data that is generated in the CRM as part of the patient journey while they are seeking and on therapy. This includes integrations with multiple clients, pharmacies, and third-party vendors via file feed or API. We're seeking a proactive, detail-oriented, and process-driven Business Analyst to join our team and establish standards, streamline processes, and enforce consistency. **Responsibilities** + Lead and standardize the project estimation process as it relates to Data Hub to drive efficiencies and meet estimation SLAs + Standardize the User Story process within Data Hub + Document and maintain Data Hub best practices, checklists, playbook, specifications, and other relevant documentation + Collaborate with multiple stakeholders to identify opportunities and translate business needs into data feed and/or migration solutions + Communicate requirements clearly and effectively to both technical and non-technical audiences + Maintain weekly project reports, client request tool, and other reporting channels + Write detailed and consistent User Stories as it relates to the clients' data needs and the project ask at hand + Understand the upstream and downstream impacts of data in the Sonexus technology ecosystem + Work in conjunction with the BA and QA CoE to ensure timely communication, technical accuracy, thorough requirements, and other project necessities + Learn the Sonexus business, its clients, and internal processes + Stay current with emerging data technologies and methodologies **Qualifications** + Bachelor's degree in a relevant field (e.g., Data Science, Computer Science) or equivalent experience preferred. + 5+ years of experience in IT business analysis, preferably in healthcare or pharmacy-related domains preferred. + High proficiency in SQL and cloud-based data environments (GCP preferred). + Strong experience with data visualization tools (e.g., Power BI or Tableau). + Familiarity with healthcare/pharmacy data sources and metrics is a plus. **What is expected of you and others at this level** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **Anticipated salary range:** $80,900 - $115,500 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 03/08/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

Responsible for providing assistance, services, resources, referrals, and consultation on various Non-Medical Counseling (NMC)/Employee Assistance Programs (EAP) and work/life issues to military service members and their families. Demonstrates an ability to effectively handle and manage high-risk calls with professionalism and in accordance with established protocols. Maintain the highest degree of sensitivity, compassion, and respect for Service members and their families. + Assesses the needs of the caller to ensure first-call resolution of all presented needs. + Educates participants on specialty program offerings, promote services, and demonstrate knowledge of military culture. + Conducts comprehensive professional assessments of users' needs for core NMC/EAP and work/life services, which can include but are not limited to, non-medical counseling, health and wellness, and other specialty and add-on services. + Identifies high-risk cases and responds as indicated in accordance with established protocols. + Deescalates callers, navigates resources, resolves complex concerns, and assesses and takes action in crisis situations. + Ensures all calls are handled according to contractual service standards and document all cases in the Case Management System (CMS). + Performs call follow-up and reporting as assigned. + Demonstrates outstanding customer service. + Demonstrates understanding of military culture and addresses Service members by their rank, thanks Service members and their families for their service, and has excellent empathic listening skills paired with appropriate clinical interventions. + Works with team to complete all annual compliance requirements such as External Certification Authority (ECA) renewal as well as annual training such as Cyber Awareness and PII to ensure access to the CMS system is maintained. **Minimum Qualifications** + Master's degree in social work and Family Therapy, Counseling, or other human services field + State Licensure to practice independently (LCSW, LPC, LMFT) preferred + 1-2 years of relevant post-graduate work experience in counseling, social work, and mental health services. Prior experience working with military and/or Veterans populations preferred. Military spouse or family member experience in a military community highly desirable **Other Job Specific Skills** + Must be a U.S. Citizen + Knowledgeable of mandated procedures for child and elder abuse situations + Familiar with core services areas of child development, parenting, adoption, education, and service for older adults + Exceptional written and verbal communication skills + MS Office skills (Word, Excel, PowerPoint) and ability to type 50 wpm + Excellent organization and time management skills + Comply with all HIPAA regulations + Current Tier 2 suitability public trust clearance is desirable, ability to obtain is required. **Compensation Ranges** Compensation ranges for ASM Research positions vary depending on multiple factors; including but not limited to, location, skill set, level of education, certifications, client requirements, contract-specific affordability, government clearance and investigation level, and years of experience. The compensation displayed for this role is a general guideline based on these factors and is unique to each role. Monetary compensation is one component of ASM's overall compensation and benefits package for employees. **EEO Requirements** It is the policy of ASM that an individual's race, color, religion, sex, disability, age, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies. All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, disability, or age. All decisions on employment are made to abide by the principle of equal employment. **Physical Requirements** The physical requirements described in "Knowledge, Skills and Abilities" above are representative of those which must be met by an employee to successfully perform the primary functions of this job. (For example, "light office duties' or "lifting up to 50 pounds" or "some travel" required.) Reasonable accommodations may be made to enable individuals with qualifying disabilities, who are otherwise qualified, to perform the primary functions. **Disclaimer** The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. $44100 - $70,000 EEO Requirements It is the policy of ASM that an individual's race, color, religion, sex, disability, age, gender identity, veteran status, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies. All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, veteran status, disability, gender identity, or age. All decisions on employment are made to abide by the principle of equal employment.

Quantum Work Advisory, a dynamic and innovative subsidiary of Allegis Group, specializes in workforce technology and workforce transformation advisory services. Supported by Allegis Group's 40-year legacy and $15 billion in revenues, we are committed to transforming workforce strategies and enhancing organizational performance. Learn more at quantumwork.com. OUR COMMITMENT We are dedicated to helping organizations design and execute workforce transformation. By leveraging the power of design thinking, AI, and automation, we create seamless, enjoyable digital experiences that make technology work for you - not the other way around. Our innovative, people-first design methodology ensures that we deliver transformational services tailored to meet your unique workforce needs. OUR APPROACH | DESIGN THINKING Our experienced consultants utilize journey mapping and "how might we?" frameworks to scientifically validate our strategic choices. By fostering user empathy, we enhance workforce collaboration and the execution of your digital transformation strategy. Job Description Don't see the perfect role open right now? That's okay! Our Talent Pool is your way to raise your hand and say, "I'd love to be part of QWA when the timing is right." By joining, you'll stay connected and be first in line when new opportunities like the Change Management Consultant, open up. Why Join? + You're letting us know you'd like to be considered as new roles open up. + We'll already have your information, so you won't need to reapply each time. + Our team will reach out if a position looks like a great fit for your skills and interests. If you're passionate about driving organizational change and ensuring successful adoption of new technologies and processes, this is the best way to stay connected. About the Change Management Consultant Role As a Change Management Consultant, you'll lead enterprise-scale change initiatives for clients undergoing transformation projects. You'll design and execute change management strategies that build awareness, drive adoption, and reinforce new ways of working. Key Responsibilities + Lead change management efforts on large-scale client projects, ensuring successful communication and adoption. + Apply certified change management methodologies to deliver high-quality outcomes. + Collaborate with internal and external workstreams to integrate change management throughout the project lifecycle. + Develop and manage change management documentation: plans, communication strategies, and training programs. + Build awareness and reinforce change within client organizations using proven methodologies. + Draft and own all manuals, communications, and training materials for future-state programs. + Train and mentor junior team members. + Identify and deploy process improvement strategies to enhance project methodologies. + Drive creative solutions for change through technology and automation where possible. What We're Looking For To thrive in our Talent Pool and in a future Change Management Consultant role you'll bring: Certified Expertise + Change management certification (e.g., Prosci or similar) required. + Strong understanding of HR/Workforce industry practices. Strategic & Communication Skills + Ability to design and execute communication and training plans. + Skilled at building awareness and reinforcing change across organizations. Collaborative & Client-Focused + Ability to partner with multiple workstreams and stakeholders. + Strong facilitation and relationship-building skills. Continuous Improvement Mindset + Eagerness to enhance methodologies and deploy innovative solutions. Why QWA? + Innovative Environment: Be part of a forward-thinking company at the forefront of workforce technology. + Growth Opportunities: Shape and grow a business unit with significant potential. + Supportive Network: Leverage the resources of Allegis Group, a leader in talent solutions. + Impactful Work: Drive transformation and deliver meaningful results for clients. Ready to raise your hand? Join our Talent Pool today and stay connected for future Change Management Consultant opportunities at QWA. Qualifications + Thorough understanding of the end-to-end Contingent Workforce Management process, including successful change management strategy and execution + Ability to communicate technical and business information and effectively present conceptual information to all levels of internal and external management + Demonstrated competency in strategic thinking with strong abilities in relationship management, working with demanding stakeholders, and driving change adoption + Experience in working with cross-functional teams to enhance their efforts and deliverables through effective CM + Demonstrated competency in self-discipline and independently completing project deliverables + Excellent verbal and written communication skills + Advanced in ability to maintain very detailed documentation as mentioned in Responsibilities Section + Intermediate knowledge of VMS technologies, MSPs, and the Procurement/HR/Tech landscape as a whole + Advanced with Microsoft Office Suite, specifically Visio + Ability to travel up to 25% Experience & Education + Four to Six (4-6) years of HR industry experience + Four to Six (4-6) years of Change Management experience + Change Management certification, preferable ADKAR, Prosci, CCMP, MSI, etc. + Bachelor's Degree or equivalent experience Additional Information Location disclaimer: This position is open to North America locations outside of California, Colorado, New Jersey, New York, Washington and Maryland. At AGS, we recognize our people are our strength. We are an equal opportunity (M/F/Disability/Veterans) and consider all applications without regard to race, gender, sexual orientation, gender identity, age, color, religion, national origin, veteran status, disability, genetic information or any other status protected by applicable law. We value our people, their varying perspectives and are committed to fostering an environment where they can bring their whole selves to work. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email Accommodation@allegisglobalsolutions.com for accommodation options. In accordance with the Immigration Reform and Control Act of 1986, employment is contingent upon verification of identity and authorization to work in the United States. All persons hired will be required to complete Form I-9 and provide acceptable documentation as required by law.

**Responsibilities** The Senior Manager, Biologics Drug Substance is responsible for mid-late stage biologic products development, including developing, optimizing and scaling up downstream or up stream bioprocesses for the commercial production of biologics, ensuring the robustness, scalability, and compliance of downstream or upstream operations. **** + Manage the technical aspects ofdownstream or upstream processoptimization, scale up andtechnology transfers to CDMOs, including documentation review, gap analysis, and risk assessment. + Support process characterization(PC)andprocess validation activities (PPQ) fordownstreamprocesses executed at CDMOs. + Oversee thedownstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls. + Act as thetechnicalleadfortrouble shooting ofdownstream process deviations or performance issues at CDMOs, including determination of product or process impact, root-cause analysis, and corrective action identification. + Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer andmaintainprocesses in the facility. **Qualifications** + Adegree in chemistry,biochemistry, chemicalengineering, or biologyand relevantpracticalexperience working inanc GMP regulated environment. + Bachelor'sdegree with10+ years ofworkexperience,or Master'sdegreewith7+years of workexperience, or PhD degree with 5+years of work experience. + For downstream:Experience withdownstream purification processdevelopment, processcharacterizationand validation + For upstream:Experience with cell line development, cell culture process development, cell culture processcharacterizationand validation. + Experienceofperformingprocessestechnical transfer and scale-up. + Knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. + Strong communication, and interpersonal skills, with the ability to influence and collaborate effectively and professionally with a wide range of individuals and organizations, both internal and external. + Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment + Ability to work independently and multi-task in a fast-moving organization. + Ability to travel up to 25%. **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.

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Job Description We are looking to fill a position for Business analyst in Salem OR. Qualifications At least 5 years of relevant experience in Software development projects as a Business Analyst is required, Additional Information In person interview is acceptable

Job Description Title of Role: Senior Manager Regulatory Affairs Department: Quality East West Tea is seeking a talented, passionate, and experienced Senior Manager Regulatory Affairs to join our Quality team! The Senior Manager Regulatory Affairs will review product formulations, labels, claims substantiations, develop Yogi's regulatory framework, and support cross-functional teams with expert regulatory guidance. Working with external legal counsel to ensure compliance and maximize commercial effectiveness. Utilizing knowledge of the Regulatory and Legal environment in USA and Canada (21 CFR part 101, 111, 7 CFR Part 205 and Natural Health Products Regulations) to ensure our products are compliant within a changing market as we maintain our portfolio and innovate in hot tea, concentrates and other new categories. Your ability to think strategically, create solutions and communicate effectively to diverse teams will be key to success in this role. WHO WE ARE: We are the well-being company that exists to inspire and enhance everyday life through trust and good will. Our guiding principles, beliefs, and philosophies shape our identity. They are the essence of our culture and define how we do what we do. We are Intentional - we chose to lead with positive intent. Mindful - we are present and aware of how we show up in the world. People - we value and respect all people and communities. Authentic - we are real and transparent with everything we do. Committed - we are committed to quality products while sustaining our planet. Trust - we consistently align our words with our actions. OUR INVESTMENT IN YOU: We have exceptional wellbeing-focused benefits including health, dental, vision and alternative care, life and disability insurance, retirement, paid time off, company picnics, social activities, and a surprise every so often! Who doesn't love a surprise? This position has a preference to be located in Eugene, Oregon, will consider remote. As a certified B Corp, we're a company that lives our values every day. We work in a LEED certified facility which prioritizes the planet in our daily operations and optimizes our employee experience while at work. We prioritize sustainability as a business by embedding it into our values, our strategic priorities, our decision-making, and our resource allocations. Our Nourish Market provides employees subsidized healthy lunch and snack options. We commit to our purpose in every aspect of our culture. We have employees that are committed to “Doing Good” in our community and around the world. We are a growing company with products that customers love. We believe in investing in you and your growth and development. WHAT YOU'LL OWN: Content Review and Compliance 50% of time Review and approve product formulations, labels, and claims for compliance with 21 CFR 101, 21 CFR 111, USP 561, 7 CFR Part 205, US FDA/DSHEA and other applicable regulations and have a working knowledge of international regulations (e.g., NHP SOR/2003-196) Create, lead and collaborate on claims substantiation process to ensure ingredient usage, nutritional limits and health claims are aligned with country-specific regulatory requirements Lead cross functional teams through optimization of label/content review processes to assess potential impact on the company's product portfolio and advise on risk mitigation strategies Oversee regulatory monitoring and horizon activities- review and analyze the new and emerging regulations and trends from government agencies that affect the company Ensure that information concerning such regulations and requirements, especially new or modified, is distributed to appropriate decision makers Strategic Responsibilities 20% of time Support to Brand, R&D for innovation and Renovation Product Development including ingredient status, permissible limits, and labeling requirements to ensure product concepts are regulatory-compliant from the early stages of development Track and analyze draft regulations, standards, and global regulatory trends Lead relationship management on behalf of the company with appropriate regulatory agencies (FDA, QAI, Health Canada) and customers (for regulatory matters) ensuring strong collaborative partnerships Operational Responsibilities 30% of time Key relationship manager for external certifying partners Develop, monitor, and report on Key Deliverables in regulatory affairs (e.g., adverse events and significant adverse events) Provide leadership as an engaged business partner between key stakeholders (QA, R&D, Sales, Marketing, Consumer Affairs, Operations) to ensure questions and questionnaires and other communications are completed to ensure speed to market WHAT YOU KNOW AND HAVE EXPERIENCED: Bachelor's or Masters in Science, Food Science, Nutrition, or related field 10+ years of experience in regulatory affairs within food and supplements (experience in both required) in FMCG/CPG Strong understanding of applicable US regulations (not limited to 21 CFR 111, USP 561, 7 CFR Part 205, US FDA/DSHEA, Prop 65 and AB 347 in California) Professional experience with claims substantiations in supplements and food Experience in handling product registrations and compliance for Health Canada preferred YOU'LL BE A GREAT FIT: Strong critical thinking ability to navigate and solve complex problems Solid work ethic, self-starter, and result-oriented Natural ability to develop strong, trusting relationships Enjoys collaborating with cross-functional partners Responsible and a high degree of ownership Thrives in an ever-changing work environment Effectively managing a multitude of work responsibilities Balances attention to detail and swift execution

Norstella is a premier and critical global life sciences data and AI solutions provider dedicated to improving patient access to life-saving therapies. Norstella supports pharmaceutical and biotech companies across the full drug development lifecycle - from pipeline to patient. Our mission is simple: to help our clients bring therapies to market faster and more efficiently, ultimately impacting patient lives. Norstella unites market-leading brands - Citeline, Evaluate, MMIT, Panalgo, Skipta and The Dedham Group and delivers must-have answers and insights, leveraging AI, for critical strategic, clinical, and commercial decision-making. We help our clients: + Accelerate the drug development cycle + Assess competition and bring the right drugs to market + Make data driven commercial and financial decisions + Match and recruit patients for clinical trials + Identify and address barriers to therapies Norstella serves most pharmaceutical and biotech companies around the world, along with regulators like the FDA, and payers. By providing critical proprietary data supporting AI-driven workflows, Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient, innovative, and responsive to patient needs. **The Role: RWD Analytic Consultant** We are currently seeking a high energy, motivated and passionate expert in RWD and the pharmaceutical industry to join our RWD Engagement Team as a RWD Analytic Consultant to support our delivery of RWD engagements across the life sciences industry. The ideal candidate will be passionate about sleuthing through RWD to unpack insights and answers to some of the most challenging business problems our clients face. This role's creation is in reaction to the demand for Norstella's newest service offerings leveraging Norstella's unified Real World Data asset, a combination of claims, lab, SDOH and EMR data. You will be joining an organization hard wired for innovation and specialization to meet the high demands of our biopharmaceutical and life sciences client base. You will join a high-performing team empowered to work creatively to deliver solutions that enable patients to access therapies they need. This role requires a combination of business acumen, analytical, technical, and commercial expertise to effectively deliver Norstella's RWD solutions. Our RWD offerings include cutting-edge data solutions and expert advisory services alongside advanced technologies such as real-world data, machine learning and predictive analytics. It is critical that an individual in this role has worked in and understands the dynamics of the US healthcare ecosystem. **Responsibilities:** -As an RWD Analytic Consultant, you will play a crucial role in supporting life sciences analytical use cases by querying and analyzing a wide range of healthcare data sources, including claims, lab results, electronic medical records (EMR), and other real-world data -Your expertise in SQL and data analysis will contribute to enhancing our understanding of healthcare trends, optimizing patient care, and driving evidence-based decision-making -Collaborate with cross-functional teams, including clinicians, data scientists, statisticians, and healthcare professionals, to identify and define analytical requirements and deliver actionable insights -Clean, validate, and transform raw data into structured formats suitable for analysis, ensuring data quality and integrity throughout the process -Develop and maintain data documentation, including data dictionaries, data mappings, and data lineage, to ensure data transparency and accessibility -Translate analytic outputs into consultative business insights **Qualifications:** -2+ years of professional experience working hands on with RWD (e.g., open/closed claims, APLD, lab, EMR/EHR, hospital chargemaster, billing codes, etc.) -Understanding of life sciences industry and US healthcare ecosystem -Strong problem-solving and analytical skills, with attention to detail -Strong Excel and PowerPoint skills -Proficiency in querying relational databases (SQL experience preferred) -Ability to work collaboratively in a team environment, as well as independently, with a proactive and self-driven approach -Client-facing experience a plus -Entrepreneurial spirit, results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel **Location: Remote US or Canada** **Our Guiding Principles for success at Norstella:** 01: Bold, Passionate, and Mission-First 02: Integrity, Truth, and Reality 03: Kindness, Empathy, and Grace 04: Resilience, Mettle, and Perseverance 05: Humility, Gratitude, and Learning **Benefits:** -Medical and Prescription Drug Benefits -Health Savings Accounts (HSA) or Flexible Spending Accounts (FSA) -Dental & Vision Benefits -Basic Life and AD&D Benefits -401k Retirement Plan with Company Match -Company Paid Short & Long-Term Disability -Paid Parental Leave -Paid Time Off & Company Holidays **_Please Note - All candidates must be authorized to work in the United States. We do not provide visa sponsorship or transfers. We are not currently accepting candidates who are on an OPT visa._** _The expected base salary for this position ranges from $100,000 to $120,000. It is not typical for offers to be made at or near the top of the range. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, licensure or certifications obtained. Market and organizational factors are also considered. In addition to base salary and a competitive benefits package, successful candidates are eligible to receive a discretionary bonus._ _Norstella is an equal opportunity employer. All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law._ _Sometimes the best opportunities are hidden by self-doubt. We disqualify ourselves before we have the opportunity to be considered. Regardless of where you came from, how you identify, or the path that led you here- you are welcome. If you read this job description and feel passion and excitement, we're just as excited about you._ _All legitimate roles with Norstella will be posted on Norstella's job board which is located at norstella.com/careers. If a role is not posted on this job board, a candidate should assume the role is not a legitimate role with Norstella. Norstella is not responsible for an application that may be submitted by or through a third-party and candidates should proceed with extreme caution if a third-party approaches them about an open role with Norstella. Norstella will never ask for anything of value or any type of payment during or as part of any recruitment, interview, or pre-hire onboarding process. If you are aware of or have reason to believe a job posting purportedly for a role with Norstella is fraudulent or otherwise not authorized by Norstella, please contact the Company using the following email address:_ _[email protected]_ _._ Norstella is an equal opportunity employer. All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law.

**What Compliance contributes to Cardinal Health** The Compliance Department is responsible for implementing all elements of an effective compliance program. Compliance develops and implements policies and procedures to ensure compliance with all applicable laws and Cardinal Health's high ethical standards. The team proactively completes risk assessments to identify legal and compliance risk and develops and conducts training and monitoring programs to mitigate risk. Compliance works closely with Legal and Regulatory subject matter experts to provide guidance to employees on compliance with Cardinal Health's policies and procedures. **Responsibilities** + Develop and maintain tracking tools to assess compliance with applicable regulations, policies, procedures, and internal control processes across all organizational levels. + Leverage data and analytics to identify, monitor, and report on emerging healthcare compliance risks. + Consolidate data obtained through risk assessments with key stakeholders to build and maintain a robust analytics repository that supports proactive risk monitoring. + Identify and implement opportunities to enhance global compliance processes through automation and optimized workflows. + Design and build advanced compliance dashboards in collaboration with business and compliance partners to enable effective decision‑making. + Analyze complex datasets to identify trends, anomalies, and insights that inform compliance strategies. + Demonstrate strong technical expertise with data and analytics tools to support program objectives. + Ability to design, interpret, and clearly communicate data models, dashboards, and automated reporting mechanisms. **What Is Expected of You and Others at This Level in Ethics & Compliance** + Apply advanced knowledge of legal and compliance concepts, principles, and technical capabilities to execute a broad range of responsibilities. + Demonstrate strong verbal communication skills with the ability to translate complex or data‑driven insights into clear, actionable guidance. + Collaborate effectively across functions and with stakeholders at all levels to support compliance objectives. + Work independently, implementing action plans and delivering high‑quality results based on general guidance. + Exhibit excellent organizational skills, with the capacity to manage multiple priorities in a fast‑paced environment. + Maintain a customer‑focused mindset, proactively seeking to understand stakeholder needs and provide thoughtful, solution-oriented support. **Qualifications** + Proficiency with analytics and visualization tools (e.g., Power BI, Tableau). + Ability to extract, transform, and analyze complex datasets using tools such as Alteryx, SQL, Python, or advanced Excel. + Experience applying statistical or analytical methods to identify trends, risks, anomalies, and actionable insights. + BA/BS in applicable field. Degree in business intelligence, statistics, data analytics, or related discipline preferred. + 3-5 years' experience in relevant healthcare compliance positions and/or data analysis roles preferred. **Anticipated salary range:** $80,500 - 104,500 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 3/23/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

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.