TEMP - GPS Standards and Training Manager
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Working from home
- Start date
- Sep 15, 2020
View more
- Discipline
- Administration, Training
- Required Education
- Bachelors Degree
- Position Type
- Contract
Job Details
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
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert