Senior Manager, Clinical Compliance Process & Procedures

Recruiter
Regeneron
Location
Tarrytown
Salary
Competitive
Posted
Jul 17, 2017
Closes
Jul 19, 2017
Industry
Pharmaceuticals
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
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:

Within the team of Clinical Compliance Process & Procedures, this position leads/facilitates the Procedural Document (PD) development/revision process with Functional Subject Matter Experts (SMEs) of Clinical Development and Regulatory Affairs. This includes the development of project plans, timelines, transition/implementation plans and information/training as needed for successful launch of the procedure within the organization.

Responsibilities:
  • Functioning as PD Manager, leads/facilitates Procedural Development Project Plan with
functional owner(s) SME to support development/improvement of process (New and Revised)
  • Coordinates the development, review, comment management and approval of PD with the PD
Author/ PD Writer. May assist in the writing of the PD and associated documents, as
needed
  • Initiates cross-functional Management review, as needed for agreement of major process
changes
  • Assures that PD's have the appropriate SME review, do not conflict with other procedures or overall GCP requirements
  • Assures that an appropriate transition, communication and implementation plan is developed with functional owner(s)
  • May design, develop and facilitate face to face information/training sessions, performance support tools and learning programs (e.g. eLearning) to support the implementation of new/revised PD and associated documents
  • Works with Technical Training in assuring that CDRA training requirements are implemented and current within the REGN Learning Management System
  • Facilitates and assists in the development of Corrective and Preventative Plans as a result of QAA Process audits
  • Tracks and develops training compliance reports based on internal requirements (e.g. Read and Understand of PDs)
Requirements:
  • Bachelors with at least 6 years of relevant industry experience
  • 5 years' experience working in a Clinical Compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills in Good Clinical Practice and SOP Development; knowledge in Good Pharmacovigilance Practice a plus
  • Demonstrates competency in the design/development of SOPs, supporting documents and performance support tools
  • Strong organizational and project management skills
  • Excellent communication skills and ability to work with people in all levels of the organization and externally
  • Demonstrates skills in problem solving, works independently and in a team environments
  • Experience using Electronic Document Management systems is preferred
  • Ability to multi-task and manage conflicting/changing priorities
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 Regenerons 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.