TEMP-Monitoring Oversight Associate

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 Monitoring Oversight Associate is an integral part of the Monitoring Oversight group who coordinates multiple activities in support of the Monitoring Oversight process which include, assigning oversight visits to Oversight CRAs, drafting the Monitoring Oversight Plan template and supporting the authoring activities to finalization, tracking performance metrics and generating reports, acts as a support to the Central Monitors in particular during preparation of materials for Quality and Risk Review meetings. The Monitoring Oversight Associates is also responsible for the collection, distribution and tracking of study-specific training documents to the oversight team.

Responsibilities:

• Provides support in preparation for the CRO kick-off meeting (eg. creates presentations, metrics reports).

• Responsible for supporting CRO Monitoring Oversight Plan template authoring activities

• Coordinates the dissemination of study-related training materials and arranging any applicable system access for the Oversight CRAs

• Creates and maintains CRO CRA study-specific assignment lists

• Assigns Oversight Visits coordinating with Oversight CRA schedules

• Tracks Oversight Visit progress and status of visit reporting

• Support the production of metrics, reports and trending of visit findings

• Supports Oversight Central Monitors during study-specific Quality and Risk review meetings

• Maintains ongoing communication with study teams to ensure awareness of oversight monitoring progress

• Participates in departmental process improvement initiatives

• May require 25% travel

Requirements:

Bachelor's degree with a minimum of 1 year industry related work experience or an advanced degree in a related field with a minimum of 6 months to 1 year of relevant work/therapeutic expertise.

• Working knowledge of clinical drug development process as well as ICH, GCP guidelines

• Demonstrates the ability to prioritize and organize workload

• Effective communication and interpersonal skills; ability to build relationships internally and externally

• Has a proven administrative ability to effectively support the necessary teams

• Ability to work independently and as part of a cross-functional team

• Proficiency in Microsoft Office applications

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.