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)