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Sr. Clinical Supply Operations Specialist

2 months ago

Armonk, United States Regeneron Pharmaceuticals, Inc. Full time

The Sr. Clinical Supply Operations Specialist provides support to the Clinical Drug Supply & Logistics group in the Investigational Product (IP) distribution process, ancillary supplies process and comparator procurement process, for one or more molecules across multiple Therapeutic areas supporting highly sophisticated studies as well as long-term departmental and cross-functional projects and ongoing continuous improvement initiatives. May lead short-term projects. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities regulations / guidelines and Regeneron Standard Operating Procedures (SOPs) / Work Practice Documents (WPDs). This role applies to internally sourced studies and/or CRO/Partnered studies.A typical day might include the following:

Solve complex problems, and initiate completion of the following items within broadly defined practices and policies including selecting methods, techniques, and evaluation criteria for obtaining results related to:

  • IP Supply & Inventory Planning
  • IP Shipments
  • IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)
  • Ancillary Supply & Inventory Planning/Management
  • Comparator Planning & Management
  • Financial Forecasting, Budgeting & PlanningThis role might be for you if:
    • You have foundational knowledge of the clinical drug development process and clinical trial methodology including the inner-workings of cross-functional partners
    • You are knowledgable of International Council of Harmonization (ICH) / Good Clinical Practices (GCP) & regulatory guidelines/directives
    • You are Proficient in MS Word & Excel
    • You can come up with solutions and work in ambiguity

      To be considered for this opportunity, we expect you to have 3 years of experience in the life sciences within Clinical Supplies, Regulatory, Quality, Manufacturing or Supply chain. We are also expecting you to have a bachelor's degree. Lastly, we require you to be in our office a few days a week.

      Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels

      Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

      For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

      Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.