Associate Director Inspection Readiness & Data Management
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Basking Ridge, New Jersey
- Start date
- Nov 10, 2022
View more
- Discipline
- Clinical, Clinical Data, Information Technology, Bioinformatics, Business/Data Analytics, Science/R&D, Oncology, General
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Responsible and accountable for handling, advising and coordinating Inspection Readiness and CAPA Management activities within DM Operations. Lead the group to provide full support of HA inspections with enhanced regulatory awareness. Be the primary point person for all inspections involving the Data Management function, and ensure CAPAs are accurately drafted and closed.
In this role, a typical day might include the following:
- Establish and maintain a partnership relationship with GCP Compliance roles and customer-orientated approach within the DM Inspection Readiness and CAPA Management group
- Responsible for proposing/defining internal DM quality-related metrics as well as ongoing collection and quarterly reporting of DM quality-related metrics including inspection-related metrics and governance of HA responses and CAPA fulfillment.
- Coordinate with GCP Compliance to assess the portfolio for near, medium, and longer term likelihood of future DM-related inspection targets. Based on this info, use a risk-based approach to selectively perform internal quality reviews as well as prioritization of efforts to remediate any historical problems.
- Support the improvement in quality within Data Management by proactively identifying and addressing areas of concerns from Health Authority inspection findings to avoid downstream issues.
- Collaborates closely with Global Development functions, to ensure that CAPA fulfillment activities are defined, measured, handled and that findings are used to improve efficiency and quality of clinical trial collection, analysis, reporting and submission across the portfolio of studies.
- Ensures adequate resources are in place to support all company inspections.
- Accountable to ensure that findings from audits, inspections, and internal reviews, are strategically translated into positively framed useful feedback to drive improvement.
To be considered you should have Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. At least 5 or more years of clinical data management operations or data management experience and proven track record in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually)
$145,200.00 - $237,000.00Company
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
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