Senior Clinical Supply Operations Specialist

Regeneron Pharmaceuticals, Inc; New Jersey; On-site; USD 84,000 - 137,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Clinical Supply Operations Specialist to support the IP distribution, ancillary supplies, and comparator procurement across multiple studies.

Located in Warren, NJ or Armonk, NY with up to 25% travel, the role involves leading complex supply planning and ensuring regulatory compliance. The successful candidate will have a Fundamentals in the clinical drug development process and ICH/GCP knowledge, plus strong MS Word/Excel skills and a

Qualifications

• BS/BA degree required with 3+ years in Clinical Supplies, QA/Regulatory, Precision Medicine, Supply Chain, Manufacturing or equivalent biopharma experience.
• Fundamental knowledge of the clinical drug development process and trial methodology.
• Familiarity with ICH/GCP and regulatory guidelines/directives.
• Proficiency in MS Word and Excel.
• Strong problem solving, time management, communication, and collaboration skills.

Responsibilities

• IP Supply & Inventory Planning including ARRD and reconciliation activities.
• IP Shipments management, depot transfers, and temperature excursion oversight.
• eTMF management: EDL creation and document control; QA/QP release tasks.
• Ancillary Supply planning, including procurement support, shipping and logistics.
• Comparator planning and market intelligence; manage document storage and related processes.
• Financial forecasting, budgeting, planning, and demand updates.

Skills

MS Word

MS Excel

Problem Solving

Time Management

Ambiguity Tolerance

Action Oriented

Adaptability

Collaboration

Communication

Detail Orientation

Education

BS/BA degree in related field

3+ years in Clinical Supplies/QA/Regulatory/Supply Chain/Manufacturing or related biopharma

Tools

MS Word

MS Excel

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. 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 complex studies as well as long-term departmental and cross-functional projects and on-going 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Warren, NJ or Armonk, NY

Travel percentage: Up to 25%

Discover your role

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:

• IP Supply & Inventory Planning
  • Accountability, Reconciliation, Returns & Destruction (ARRD)
  • Internal System Management including lot creation, batch status, and inventory maintenance
  • Assessment and Oversight activities (risks, stocking levels, trends)
• IP Shipments
  • System and Non-system generated Shipments
  • Depot transfers
  • Temperature Excursion Management
• IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)
  • Expected Document List (EDL) creation
  • eTMF Document Management per regulatory requirements
  • QA/QP Release Management
  • Pack-and-label kit and sequence reconciliation
  • Inspection Readiness activities
  • IRT management activities including IRT Alert management and UAT activities
  • Suspected Serious Non-Compliance support
• Ancillary Supply & Inventory Planning/Management
  • Procurement support (Includes Work Order Management)
  • Vendor RFI support
  • Supply Planning & Inventory Management
  • Ancillary Supply Plan creation
  • Shipping & Logistics (Includes International Logistics requirements for Ancillaries)
  • Shipping & logistics activities
  • Temperature Excursions
  • Lot management
  • eTMF activities
  • ARRD activities
• Comparator Planning & Management
  • Market Intelligence Reports
  • Quote/PO/Requisition Process Support
  • IMN Creation
  • Document Storage
  • Temperature Excursions
• Financial Forecasting, Budgeting & Planning
  • Forecast Submissions
  • Order Ticket Entry
  • Demand Updates

Work is performed under general direction and reviewed upon completion for adequacy in meeting objectives. Candidate is expected to participate in determining objectives of assignment and be able to plan schedules and arrange own activities in accomplishing objectives. Candidate will represent CDSL as a prime contact on contracts or projects. He/She will interact with senior internal and external personnel on significant matters often requiring coordination between organizations.

JOB REQUIREMENTS:

Fundamental knowledge of the clinical drug development process and clinical trial methodology including the inner-workings of cross-functional partners.

Fundamental knowledge of International Council of Harmonization (ICH) / Good Clinical Practices (GCP) & regulatory guidelines/directives

• Proficient in MS Word & Excel
• Efficient Problem Solving
• Excellent Time Management
• Thrives in Ambiguity
• Action Oriented
• Adaptability
• Collaborates Effectively
• Well Organized
• Communicates Effectively
• Detail Oriented

MINIMAL EDUCATION REQUIRMENTS

BS/BA degree in a related field. Minimum of 3+ years of experience in the following fields:

• Clinical Supplies
• QA/Regulatory
• Precision Medicine
• Supply Chain
• Manufacturing
• Or equivalent research/commercial biopharma experience

Does this sound like you? We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$83,800.00 - $136,800.00