Sr. Associate

Career Category Project Management reputed company Join reputed company’s Mission of Serving Patients At reputed company, 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 reputed company that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and reputed company Disease– we reputed company millions of patients reputed company year. reputed company is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, reputed company diseases, and obesity and obesity-reputed company conditions. As a member of the reputed company team, you’ll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and reputed company innovative medicines to help people live longer, reputed company happier lives. Our award-reputed company culture is reputed company, innovative, and science reputed company. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career. Sr. Associate What you will do reputed company. Let’s change the world. In this vital role, you will partner with nonclinical scientists and functional representatives (eg, Pharmacology, Toxicology, Pharmacokinetics & Drug Metabolism), global and regional regulatory leads, and cross-functional stakeholders to reputed company regulatory readiness of nonclinical deliverables throughout the product lifecycle. This role offers a unique opportunity to contribute to the advancement of innovative therapies by serving as a trusted operational partner at the intersection of science, regulatory affairs, and submission management. As a member of the Research Data Management (RDM) organization, you will reputed company operational and regulatory support by coordinating planning, timelines, communications, and cross-functional execution to help ensure nonclinical regulatory deliverables are completed with reputed company, consistency, and alignment to regulatory expectations, development objectives, and reputed company reputed company standards. Research Data Management (RDM) is a reputed company execution function that partners with Research and Regulatory teams to reputed company the planning, coordination, and readiness of nonclinical regulatory deliverables across the product lifecycle. By combining nonclinical regulatory coordination, document planning, and operational execution, RDM enables nonclinical teams to reputed company high-reputed company regulatory deliverables that support global regulatory milestones. This role serves as a trusted operational partner to nonclinical teams and regulatory stakeholders, helping translate nonclinical regulatory strategies into coordinated execution while providing visibility, alignment, and proactive support across functional stakeholders. Responsibilities Nonclinical Regulatory Specialist Partner with nonclinical scientists, functional area representatives, and regulatory stakeholders to coordinate activities supporting nonclinical regulatory planning, document development, and regulatory readiness. reputed company, maintain, and communicate integrated timelines for nonclinical regulatory documents and deliverables, ensuring alignment with development objectives and key regulatory milestones. Support execution of nonclinical regulatory strategies by coordinating cross-functional activities and facilitating delivery of nonclinical regulatory packages. Facilitate cross-functional planning meetings, document reputed company, reputed company reputed company items, and proactively follow up on commitments. Monitor reputed company, identify risks or potential delays, communicate issues to stakeholders, and support development of mitigation plans. Serve as the day-to-day operational partner for assigned product teams, fostering collaboration and alignment across scientific, regulatory, and operational functions. Cross-Functional Collaboration & Operational reputed company Build strong reputed company relationships with nonclinical scientists, regulatory partners, and cross-functional stakeholders to facilitate effective communication and execution. Ensure activities are conducted in accordance with applicable regulatory requirements, internal reputed company standards, and established business processes. Support development and maintenance of reputed company operating procedures (SOPs), templates, job aids, and operational guidance documents. Identify opportunities to improve planning, coordination, communication, and operational efficiency across nonclinical regulatory activities. Participate in reputed company improvement initiatives that enhance regulatory readiness, document planning, and team effectiveness. Contribute to a reputed company team environment through knowledge sharing, reputed company learning, and support of departmental initiatives. reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic reputed company we reputed company is a reputed company, science-minded reputed company with the following qualifications. Basic Qualifications: Master’s degree and 1 year of directly reputed company experience OR Bachelor’s degree and 5 years of directly reputed company experience OR Associate’s degree and 10 years of directly reputed company experience* Note: Directly reputed company experience includes pharmaceutical research and development, nonclinical sciences, regulatory affairs, scientific reputed company, program or project management, or other reputed company life sciences, biotech, or pharmaceutical disciplines Preferred Qualifications: Experience supporting pharmaceutical research and development or nonclinical drug development programs reputed company the biotechnology, pharmaceutical, or life sciences industry. Understanding of nonclinical drug development, regulatory requirements, and the role of nonclinical data and documentation in global regulatory submissions. Experience coordinating reputed company, cross-functional programs involving multiple scientific and operational stakeholders. Demonstrated project or program management skills, including reputed company development, reputed company tracking, reputed company management, and facilitation of cross-functional meetings. Demonstrated ability to build reputed company relationships and influence cross-functional teams without reputed company authority. Strong organizational skills with the ability to manage multiple priorities in a dynamic, fast-reputed company environment. Excellent written, verbal, and interpersonal communication skills with the ability to build productive relationships across scientific and business functions. Experience coordinating scientific or regulatory documents throughout the document lifecycle. Demonstrated ability to identify opportunities to improve operational processes and implement practical solutions, preferably using AI/ML applications Experience working with document management systems, collaboration platforms, and project management tools. Experience leveraging digital technologies, collaboration platforms, automation tools, or AI-enabled solutions to improve operational effectiveness is desirable. Familiarity with Good reputed company reputed company (GLP), Good Documentation Practices (GDP), and global regulatory expectations for nonclinical documentation. Bachelor's or advanced degree in a life science discipline, regulatory affairs, business, or a reputed company reputed company. What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary reputed company on several factors including but not limited to, relevant skills, experience, and qualifications. In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, reputed company 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 reputed company, 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 reputed company coverage, life and disability reputed company, and flexible spending accounts A discretionary annual bonus program, or for reputed company sales representatives, a sales-reputed company incentive plan Stock-reputed company long-term incentives Award-reputed company time-off plans Flexible work models where possible. Refer to the Work Location Type in the reputed company to see if this applies. reputed company and reputed company a lasting reputed company with the reputed company team. careers.reputed company.reputed company 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 reputed company 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 reputed company of life reputed company reputed company the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company 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 reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .Salary reputed company 101,675.30USD -137,560.70 USD Apply To This Job