Document Coordinator, Global Development Process and Procedures

Location
Tarrytown, New York, US
Posted
Nov 15, 2018
Ref
14751BR
Required Education
Bachelors Degree
Position Type
Contract
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary . The Process & Procedures P&P Document Coordinator is responsible for performing and coordinating activities that support the operations and quality of Global Development procedural documents. Job Duties . Update the master Global Development procedural document portfolio that includes all procedural documents SOP, WI, Guidelines, Job Aids, Forms, Templates . Manage and maintain document data elements and folder structures within electronic document management system EDMS under the direction of P&P Operations Lead . Initiate and organize SOP Periodic Reviews and liaise with owning department heads as directed . Support P&P Managers in procedural document life cycles and ad-hoc administrative requests . Generate metrics and reports from P&P Tracker and electronic document management system EDMS for analysis by Senior P&P Managers . Maintain list and track Quality Auditing & Assurance QAA Corrective Actions and Preventive Actions CAPAs in consultation with P&P Operations Lead . Manage P&P monthly reports including cumulative count of procedural document approvals . Handle ad-hoc requests for copies of procedural documents and other administrative needs to support P&P Operations Lead and P&P Managers . Monitor status and contributes to workflows, as requested . Requirements . Demonstrates competency with document management principles in a global regulated organization . Experience in using Electronic Data Management System EDMS . Advanced experience in Microsoft Office expert in MS Word . Self-motivated with the ability to work independently . Proven ability to work effectively with competing priorities . Excellent communication skills written and oral and ability to work with people in all levels of the organization . Basic experience in Microsoft Project is a plus Core Behavioral Competencies . Basic Project Management . Process Oriented Thinking . Critical Thinking & Problem Solving . Integrity and Trust . Attention to detail . Adherence to standards and processes BS/BA Degree with 5+ years relevant experience. MS degree and 3+ years relevant experience. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. LMR, #LI-LR1, document coordinator, document management