Job Description
We are hiring a Principal Data Integrity Specialist (Records Management) to support the site(s) documentation system and ancillary support systems. This role will support Document Control or the Information & Records Management group’s efforts that strive to improve document integrity, writing and communication. The Specialist will work on both daily tasks and project tasks and focus on one or more areas within the group: Operations, Oversight, Performance & Technology, or Risk & Data Integrity.
Essential Duties and Responsibilities include, but are not limited to, the following:
Operations
Coordinates review and revision of controlled documents, inclusive of other sites.
Develops proposals and strategies related to future-planning and growth of the group.
Prepares metric reports for management.
May coordinate document/record requests and stage documents for presentation during regulatory inspections.
May be responsible for and/or lead investigation activities and handle compliance items for department.
May review/approve changes in accordance with SOPs
May be responsible for the revision of documents for accurate grammar, spelling, punctuation, presentation, etc., and to improve clarity, syntax, logic, flow, organization, etc.
Participates in health authority interactions and preparation as related to site inspections.
Provides guidance, mentoring and training to staff and user departments in accurate use of the document/record management systems.
Oversight
Identifies risks to operations and collaboratively works with team and business to identify and implement mitigations; raises identified issues to management.
Leads internal and external partner interfaces ensuring positive relationships exist with mutual understating of each parties’ expectations and delivery against those expectations.
Champions multi-function impacting processes by ensuring process design is sound, compliant, and effective, and engages with the business ensuring requirements are clearly communicated and met.
Assists with leading initiatives that help improve employee onboarding and independence, document/record integrity and communication across the sites.
Risk & Compliance / Data Integrity
Possesses expert level understanding of regulations, standards, and guidelines as it pertains to the group operations, and partners with area personnel to apply practical education to continually improve operations.
Department subject matter expert for data integrity; comprehends the standard and ensures broad understanding across the department and application against changing business processes.
Acts as department representative to identify data and appropriately catalog and document data related requirements of business processes.
Works with department peers to implement a robust inspection ready 365 program, champion an inspection ready mindset and ensure documentation generation and maintenance all supporting successful inspections.
To be considered for this role you must hold a BS/BA degree in related field and the following amount of relevant experience for each level:
Principal: 8+ years’ experience in QA/Document Control/Records Management/Data Integrity
Staff: 10+ years' experience in QA/Document Control/Records Management/Data Integrity
May consider another degree field with relevant experience. Level and compensation are determined based on qualifications relevant to the specific role.
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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)