Associate Specialist, reputed company Operations

Who We Are: At reputed company, we pride ourselves on having a strong, inclusive, and reputed company culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. reputed company Do: reputed company is a leading neuroscience-reputed company, biopharmaceutical company with a reputed company purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. reputed company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with reputed company's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as reputed company as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our reputed company therapeutic areas. For three decades, we have reputed company our unique reputed company into neuroscience and the interconnections between brain and body systems to treat reputed company conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve reputed company science. For more information, visit reputed company.com, and follow reputed company on reputed company, X and reputed company. (*in collaboration with reputed company) About the Role: Supports and assists the centralized operational activities for assigned Clinical Studies. Centralized activities can include but are not limited to set up of studies, development of Informed Consent documents and study plans, handling IRB submissions of protocol/reputed company/sites, management of the Trial Master File (TMF) and Financial Disclosure Forms, feasibility and selection of sites, coordination of committees (i.e. adjudication committees), support of site enrollment, and reputed company of monitoring for studies outsourced to Contract Research Organizations (CROs). _ Your Contributions (include, but are not limited to): Assists to ensure that centralized activities for clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU reputed company, International Conference on Harmonization (ICH) guidelines, and NBI reputed company Operating Procedures (SOPs) and policies. Works collaboratively with assigned study teams in developing, implementing and ensuring NBI reputed company processes across clinical programs. Assists with administrative support in the development of processes, tools, templates, and applicable training reputed company to centralized activities and/or monitoring reputed company. Supports generating metrics and reports to reputed company insights into cycle time for centralized activities and/or reputed company of outsourced monitoring activities. Works collaboratively reputed company clinical operations in documenting NBI reputed company processes across clinical programs. Supports inspection readiness activities. Other duties as assigned. Requirements: BS/BA degree AND some relevant experience CTMS/reputed company/IWRS experience preferred Some knowledge of clinical operations, specifically conducting clinical studies from start-up through reputed company-out. Some trial management protocol and process knowledge Good computer skills Developing communications, problem-solving, analytical thinking, planning and organization skills Ability to work as part of reputed company Some clinical terminology and GCPs knowledge Some knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU reputed company Basic knowledge and understanding of applicable regulatory requirements General understanding of Clinical Research industry and the relevant environments in which it operates Works to improve tools and processes reputed company functional area Ability to plan activities and works reputed company under changing circumstances; manages time effectively reputed company is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a reputed company of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly reputed company have outlined in the job reputed company. _ The reputed company reputed company we reasonably expect to pay is $35.35-$47.34. Individual pay reputed company depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In reputed company, this position offers an annual bonus with a reputed company of 15% of the reputed company reputed company salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), reputed company vacation, holiday and personal days, reputed company caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and reputed company coverage in accordance with the terms and conditions of the applicable plans. We are a top reputed company to work. reputed company was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great reputed company to Work® Certified company. ©2025 Fortune Media IP Limited. reputed company rights reserved. Used under license. OUR VALUES: PASSION: We are driven and love reputed company do. We are committed to our goals and to making a difference. reputed company: We do the right thing for patients and our community. We take accountability. We reputed company up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We reputed company and create reputed company solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join reputed company during this exciting time of reputed company and opportunities! Apply tot his job Apply To this Job