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Sr. Manager GPS Standards & Training

Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: May 15, 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 critical 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. Posesses strong technical and project management skills. Oversees direct reports, if applicable. In this role, a typical day might include the following:

  • Develop, implement and maintain SOPs, work instructions, templates, forms, and business practice tools in collaboration with the Global Development Process & Procedures group as well as subject matter experts (SMEs) within and outside GPS; this includes periodic review of procedures to ensure they continue to correctly describe GPS processes.
  • Manage the GPS procedural portfolio to ensure the pharmaocovigilance (PV) system complies with global safety regulations for clinical trial and postmarketing
  • Drive standardization across GPS processes and training; support procedural document implementation
  • Establish and manage training curricula in collaboration with SMEs
  • Create and maintain training materials with SME input/support as needed
  • Deliver pharmacovigilance training to stakeholders
  • 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; manage training compliance metrics
  • Generate, contribute to, and manage departmental metrics
  • 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
  • Provide input on PV requirements (e.g., reporting, training, archiving records, etc.) for contracts
  • Collaborate with and/or manage PV vendors with respect to procedural and training aspects to support GPS activities and deliverables.
  • 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
  • Facilitate periodic review of training curriculums
  • Manage communications related to team deliverables and projects
  • Manage corrective and preventative actions as assigned
  • Provide support for audits and inspections as requested
  • Perform other duties for GPS as assigned
  • Manage and oversee the work of direct reportsThis role might be for you if:
    • Bachelor's degree in healthcare or life sciences; An advanced degree such as PharmD, RN or BSN is preferred.
    • Minimum 7+ years experience in a global Pharmacovigilance/Drug Safety department is required.
    • Minimum of 5+ years experience managing people.
    • Must have strong knowledge of global Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
    • Proven project management experience.
    • Experience managing vendors is desirable.
    • Proven track record of forging relationships to promote collaboration and driving successful projects.
    • Ability to influence others.
    • 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.
    • Strategic thinker, ability to problem-solve and make decisions.
    • Self-motivated with the ability to work effectively and independently in a dynamic environment with ambiguity
    • Must possess strong knowledge of pharmacovigilance regulations and guidelines (EMA, MHRA, FDA, PMDA, ICH).
    • Excellent knowledge of Microsoft Office (Word, Excel, PowerPoint).
    • Advanced experience analyzing data in Excel (e.g., pivot tables) and utilizing PowerPoint is highly preferred.Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Keywords: Regeneron Pharmaceuticals, Inc., Newark , Sr. Manager GPS Standards & Training, Executive , Basking Ridge, New Jersey

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