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We are hiring a Lead Document Coordinator to assist our Document Control team! As a Lead Document Coordinator, you will provide support to the process of creating, reviewing, approving, distributing, controlling and maintaining documentation to ensure effective and efficient application of GMP.

Documentation within this process includes, but is not limited to, manufacturing and packaging, laboratories, and general operations. You will need to understand the basic principles and concepts of the documentation lifecycle and associated electronic systems.

Shifts available include:

+ Wednesday- Sunday, 3rd shift, 10pm-8:30am, ET

In this role, a typical day might include the following:

Lead-Related Activities include, but are not limited to, the following:

+ Provides on-the-floor guidance and support to employees

+ Ensures employees time sheets are completed on time

+ Monitors employees training to ensure that all requirements are met, including OJT

+ Maintain up to date training records for self and direct reports

+ Perform minimally monthly performance feedback meetings with direct reports

+ Escalates all performance issues to management and/or HR

Document Structure:

+ Brings document hierarchy concepts from idea to implementation

+ Drives for alignment, improvement, and definition for existing and document type creations to further enhance simplicity of document structure and standardization

+ Partners with customers to build appropriate and efficient release strategies

Document & Workflow Management:

+ Possesses a high-level understanding of all departmental processes

+ Possesses subject matter expert in one or more departmental areas/activities

+ Provides training to others on day-to-day tasks and serves as a Qualified Trainer

+ Proficient in a wide array of departmental activities

+ Coordinates multiple Global pre-fixes and/or processes

+ May own/lead Global processes with ability to act as back-up to other processes

+ Executes tasks associated with EDMS outages

+ Manages document requests including intake, distribution, coordination, editing, review, and release

+ Lead the Quality System Enhancement Request meetings driving discussions to resolution that is efficient, compliant, and considers all impact

+ Lead the Urgent Workflow meeting driving the discussion to understand the request, it’s urgency amongst other request, potential impact to the business, and final disposition. Track metrics and analyze trends to identify improvement opportunities

Record Issuance & Archival:

+ Possesses skill set to execute all the different steps associated with the lifecycle of all records (including but not limited to, Master Batch Records, Batch Sheets, Protocol Performance Copies, Labels, Logbooks, Keys): issuance, tracking, and reconciliation

+ Acts on inventory of issued documentation where returns are delayed by partnering with owning areas to identify issues and rectify situation

+ Support document reconciliation and archival submissions of controlled documentation

Process Performance:

+ May lead data and metric presentation efforts with the ability to tell the story of the data

+ Authors reports with prospective analysis of data to forecast future performance and identify necessary process modification based on the results

+ Builds concepts for displaying data from different departmental activities into visual management tools

+ Evaluates standing metrics reports and evaluates data for Quality Operations Systems Metrics meeting, Right to Operate meeting, and other performance review meetings. Provides recommendations and solutions for identified issues

+ Develops and presents concepts, ideas and project initiatives to leadership

Technical Systems:

+ Possesses advanced level understanding of the Electronic Document Management System EDMS for understanding of system architecture, interconnections, configuration, workflow builds, and field options

+ Monitors and manages multiple QlikSense tools, Tracking Databases, EDMS, SharePoint sites, and Servers

+ Act as a System Owner back-up for one or multiple systems

Inspection Support:

+ Leads team for regulatory and internal audit and inspection logistics

+ Acts as a subject matter expert primary or secondary for audits and inspections. Speaks to departmental processes and presents to the auditor/inspector

Compliance Support:

+ Acts as subject matter expert during problem solving and investigation efforts

+ Guides/leads investigations at the EOE level.

General:

+ Manages complex initiatives for continuous improvement of processes

+ Leads departmental site and global projects

+ Leverages subject matter knowledge to assist in problem solving and investigation efforts

+ Guides/leads investigations at the NOE level. May support investigation at the EOE level

This role may be a fit for you if you have:

+ Knowledge of document databases and other electronic document management tools (e.g. eDocCompliance, FileMaker Pro)

+ Demonstrated attention to detail and organizational skills

+ Demonstrated ability to work in a team environment

+ Ability to work well under time restraints

+ Demonstrated strong problem-solving skills

+ Anticipates and identifies problems before they happen

+ Ability to look beyond the immediate problem to the big picture

To be considered for this role, you must hold a Bachelor’s degree in a related field and the following minimum amounts of relevant experience for each level:

+ Lead Document Coordinator – 2+ years

+ Lead Sr Document Coordinator – 4+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

\#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (hourly)

$27.26 - $49.04