Senior Operations Specialist, Nonclinical Development

  • Company: Shire plc
  • Location: Massachusetts, United States
  • Posted: November 02, 2017
  • Reference ID: R0015070
Under the direction of the Head of NCD Operations, the Senior Operations Specialist assists with maintaining an efficient operating environment for project-related Nonclinical Development (NCD) activities. The Senior Operations Specialist also assists in the efficient development, execution and filing of legal agreements, and related documents. The Senior Operations Specialist helps maintain the NCD contracts database, ensures electronic study- and project-related files are maintained to common standards, assists in the efficient management of study- and project-related accounts and assists the Head of NCD Operations in other activities as required.

% of Time
Job Duty and Description
  • Develop a good understanding of Nonclinical Development processes relating to legal contracts
  • Liaise with the legal department to progress legal agreements as required
  • Assist with the distribution of draft legal contracts (CDAs, MSAs, SOWs) and communicate with the involved parties to finalize the agreements as required
  • Request all contracts using on-line legal request form and process agreements through to execution
  • Ensure all legal documents are appropriately filed in electronic filing systems (PIMS and Axxerion, as appropriate)
  • Continually monitor status of legal agreements and initiate agreement renewal when required
  • Serve as an SME and champion for NCD's Preclinical Information Management System (PIMS) and its related activities
  • Take on responsibility for account creation and deactivation within PIMS, as well as training new users
  • Work closely with other PIMS users to monitor any system-related issues that need to be escalated to IT
  • Work with both the Manager of Preclinical Documentation & Compliance, the Head of NCD Operations, and IT, as appropriate, to identify and implement system and/or practice improvements
  • Demonstrate an understanding of NCD studies and the activities around them
  • Assist with maintenance of archive contracts and records
  • Ensure all studies and other activities are entered on the PIMS database and that all fields are completed as information becomes available
  • Generate a unique reference number for each study or funded activity from the PIMS database, and ensure this is always used on study-related documentation
  • File project and study-related documents in the relevant filing systems
  • Serve as an Operations contact for the FDA's Standard Exchange of Nonclinical Data (SEND) initiative and facilitate the flow of data and related documents through the established processes; as well as working to improve these process as the needs arise
  • Develop a good understanding of Shire accounting practices relating to projects and studies
  • Raise POs for project-related spends
  • Set up all new project-related vendors on PIMS system
  • Work with Finance to resolve any project-related invoice queries which come in for NCD
  • Develop a good understanding of Shire's SOP system
  • Assist with development of new departmental SOPs and Guidelines as appropriate
  • Assist with completion of on-going Shire resource tracking
  • A degree and/or equivalent experience suitable for an operations role.
  • Minimum of 5-7 years relevant experience in relevant roles sufficient to demonstrate the skills and competencies detailed below
  • Prior experience in the bio-pharma industry required
  • Experience as a lab and/or animal technician in the bio-pharma industry preferred
  • General understanding of GXP guidelines and procedures required

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