TEMP - GPS Standards and Training Manager

Location
Working from home
Posted
Sep 15, 2020
Ref
20581BR
Discipline
Administration, Training
Required Education
Bachelors Degree
Position Type
Contract
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.
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 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
  • Archive procedural and training documentation including individuals' compliance with training
  • Monitor training compliance for GPS and vendors providing safety services in partnership with GPS and other SMEs
  • Monitor GPS regulations globally for changes and collaborate with SMEs to update procedures as necessary
  • Run initiatives and projects as requested to continuously enhance the effectiveness and efficiency of GPS processes and training
  • Lead corrective and preventative actions as assigned
  • Provide support for audits and inspections as requested
This role might be for you if:
Bachelor's degree is required; master's degree is preferred. Education in the life sciences is a strong plus. Must have 7+ years of relevant industry experience.
5+ years experience in Pharmacovigilance/Drug Safety is required.
Must have experience with Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
Validated 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).

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.