• The Operations Strategy Associate role is a generalist role suited for the “all-around athlete” type. • Work within one of our Operations teams, likely starting in more execution-focused roles. • Redesign processes for reaching out to workplaces about converting them to new payment methods. • Research, vet, and onboard a new vendor that embeds AI agents. • Build predictive analytics models to catch bad payers earlier. • Spearhead a quality task force that ensures top quality for customers. • Manage a team of agents within Operations teams. • Work directly within workflows, resolving issues, and identifying improvement opportunities.

• Redesign our process for reaching out to workplaces about converting them to new methods of payment. • Research, vet, and onboard a new vendor that embeds AI agents into our customer-facing efforts. • Build an internal predictive analytics model to catch bad payers earlier with high accuracy. • Spearhead a quality task force that ensures top quality for our biggest customers. • Manage a team of agents within one of our Operations teams. • Work directly within workflows, including handling customer interactions, resolving issues, and identifying opportunities to improve the front line processes.

Premier Research is looking for a Regulatory Operations Associate I (West Coast) to join our Regulatory Operations team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. - We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. - Your ideas influence the way we work, and your voice matters here. - As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You'll Be Doing: - Create and format various basic to intermediate documents, utilizing internal processes and tools to perform the activities pertaining to electronic publishing and to meet required standards and technical requirements within specified timelines - Electronically publish components of Regulatory Agency submissions, including INDs and amendments, annual reports, safety reports, etc. - Work with relevant internal staff to ensure that source documents are received in a timely manner in order to support the generation of submissions - Perform the QC for all applications, amendments and supplements prior to submitting to Agency - Perform quality checks of others’ work - Participate in the implementation of new health agency guidelines and rules relevant to regulatory submissions - Participate in department projects that improve the department systems and processes - Assist in the review of Regulatory Operations work practices - Interact with clients, as needed What We Are Searching For: - Bachelor’s degree, or international equivalent from an accredited institution, in Science/Technology, or an equivalent combination of education and experience - 2-4 years of Regulatory Operations experience within the pharmaceutical or biotech industry - Basic to Intermediate experience using Microsoft Office and Adobe Professional - Ability to appropriately handle confidential and highly sensitive material Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized base pay for this role is between $60,000 - $100,000 USD. The actual salary will be influenced based on a variety of factors such as qualifications, skills, competencies, and proficiency for the role. We also offer comprehensive benefits packages, which may include health insurance, life insurance, retirement plan, paid time off, and an Employee Assistance Program. Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status

Career Category Project Management Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Strategic Planning and Operations Manager - External Supply – Network Strategy and Risk What you will do Let’s do this. Let’s change the world. In this role, you will operate at the intersection of strategic operations and advanced analytics, driving both business decision-making and data-driven insights across External Supply. Strategic Planning & Operations - Lead site selection, business case development, and supplier strategy for contract manufacturing organizations (CDMOs) - Drive New Product Introduction (NPI) and technology transfer activities into external manufacturing and supplier sites - Partner cross-functionally (Operations, Quality, Supply Chain, Finance, Process Development, and Strategic Sourcing) to: - Conduct landscape assessments and supplier evaluations - Lead RFP development and proposal assessments - Perform due diligence and risk assessments - Develop financial analyses and recommendations for leadership - Build and manage complex project plans, ensuring delivery on scope, timeline, cost, and quality - Lead continuous improvement initiatives to enhance efficiency, consistency, and execution across External Supply - Develop and advance business processes and strategies supporting External Supply goals Data analytics & digital capabilities to enable External Supply strategic planning & operations - Design, develop, and maintain data pipelines and analytics solutions supporting External Supply operations - Build dashboards, reports, and visualizations to provide actionable insights to business stakeholders and leadership - Analyze complex datasets to identify trends, risks, and opportunities that support External Supply operations - Apply advanced analytics and AI-enabled techniques to enhance decision-making and business process compliance and efficiency - Define KPIs and translate business needs into scalable analytical solutions - Improve data quality, governance, and usability, applying FAIR data principles including improving metadata, lineage, standardization, and reuse - Collaborate with digital/IT teams to deploy and enhance analytics tools, AI solutions, and reporting capabilities - Communicate insights clearly to both technical and non-technical audiences Why This Role is Unique This role combines: - Strategic influence (supplier strategy, business cases) - Technical depth (data pipelines, analytics, AI-driven insights) You will directly shape how External Supply decisions are made—both through operational leadership and data-driven intelligence. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of project/program management and data analytics/data science experience OR Bachelor’s degree and 4 years of project/program management and data analytics/data science experience OR Associate’s degree and 8 years of project/program management and data analytics/data science experience OR High school diploma / GED and 10 years of project/program management and data analytics/data science experience Preferred Qualifications: - Experience in biopharmaceutical manufacturing, or other regulated environments - Knowledge of External Supply, contract manufacturing, and/or supply chain operations - Demonstrated expertise in: - Technology transfer and new product introduction processes - Strategic planning, business case development, and financial analysis - Data analytics tools (e.g., SQL, Python, Power BI/Tableau) - Data modeling, governance, and pipeline development - Experience with advanced analytics, AI enabled solutions, machine learning, or predictive statistical modeling - Strong ability to translate data into business insights and decisions - Excellent stakeholder management, communication, and leadership skills - Proven ability to manage complex, cross-functional initiatives in fast-paced environments What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: - A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts - A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan - Stock-based long-term incentives - Award-winning time-off plans - Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided 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. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. .Salary Range 109,640.65USD -148,337.35 USD