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TEMP - Manager, Global Patient Safety, Standards and Training

Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: May 14, 2022

Job Description:

Reporting to the Associate Director of Global Patient Safety (GPS) Standards and Training, this position is responsible to establish and maintain procedures and policies to ensure consistency with regulatory requirements and industry standards, and to ensure training on those procedures and polices is conducted throughout the GPS department. Manages development and implementation of training as well as curriculums for GPS. Makes decisions on complex to highly complex issues regarding work approach for GPS procedural and training related tasks. Works independently across multiple areas. Receives general business direction, as needed.Essential Functions required for the job. List both technical and managerial requirements if applicable.

  • Develop, implement and maintain SOPs, work instructions, templates, forms, and business practice tools in collaboration with subject matter experts (SMEs) within and outside GPS; this includes periodic review of procedures to ensure they continue to correctly describe GPS processes
  • Establish and improve training curricula in collaboration with SMEs
  • Create and maintain training materials with SME input/support as needed
  • Manage AE training for employees, contractors and vendors
  • Monitor training compliance for GPS and vendors providing safety services in partnership with GPS and other SMEs
  • Archive procedural and training documentation including individuals' compliance with training
  • Monitor GPS regulations globally for changes and collaborate with SMEs to update procedures as necessary
  • Manage initiatives and projects as requested to continuously enhance the effectiveness and efficiency of GPS processes and training
  • Collaborates with Global Development Training and Technical Training, when applicable, to ensure training requirements are implemented for assigned roles in procedures
  • Coordinate the review cycles of assigned procedural documents and approval workflows
  • Manage corrective and preventative actions as assigned
  • Provide support for audits and inspections as requested
  • Perform other duties for GPS as assignedBachelor's degree is required; master's degree is preferred. Education in the life sciences is a strong plus. Experience in Pharmacovigilance/Drug Safety is preferred. Experience with Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems is preferred. Proven project management experience Strong organizational skills and writing skills Attention to detail and accuracy of work Excellent communication skills (written and verbal) and ability to work with people in all levels of the organization and externally Ability to effectively manage multiple priorities with a sense of urgency Self-motivated with the ability to work effectively in a dynamic environment with ambiguity Working knowledge of pharmacovigilance regulations and guidelines (EMA, MHRA, FDA, PMDA) Proficient knowledge of Microsoft Office (Word, Excel, PowerPoint)

Keywords: Regeneron Pharmaceuticals, Inc., Newark , TEMP - Manager, Global Patient Safety, Standards and Training, Executive , Basking Ridge, New Jersey

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