Director, Global Development Training

Location
Tarrytown, New York
Posted
Apr 19, 2018
Ref
11949BR
Discipline
Administration, Training
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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:

Develops performance support/training strategy for Clinical Development and Regulatory Affairs including assistance with process development/improvement, change management and CDRA on-boarding for new hires. Strong GCP focus.

Responsibilities:
• Develops performance support/training strategy for CPMO and other departments in CDRA as needed to include on-boarding for new hires to support CDRA processes
• Works with Sr. Manager, CCT (process and training) to assure the processes for Procedural Developments, Implementation and training are developed to support new/revised processes including transition plans, change management and other performance support tools as needed.
• Develops strategy to develop ongoing learning from clinical development projects and experiences with existing and newly implemented processes.
• Assures CDRA Playbook is implemented and current according to CDRA processes and practices.
• Develops learning strategies for Investigator and Site training as needed
• Responsible for CRO Partnership Training for REGN
• Maintains CDRA Playbook, Operational tools & other information sources
• Develops performance support strategies as needed with AD/Director CCT (Process Improvement)
• Assures that SABA Learning Management System is set-up to CDRA needs and that training matrixes are updated as needed for PD and Study Specific training.
• Lead process improvement projects as needed
• Supports Regulatory Inspections as needed

Requirements:

• Bachelors or Master's degree with at least 10-12 years of relevant industry experience.
• Extensive experience and knowledge in the development of performance support/training strategy for the clinical organization
• Demonstrated knowledge of clinical processes including GCP Regulations
• Excellent communication skills and ability to work with people in all levels of the organization
• Demonstrated skills in taking initiative and working independently
• Demonstrated experience leading process improvement initiatives
• Regulatory Inspection experience desired but not required for this position.

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.

Requisition Number: 11949BR