Associate Director, Global Development (GCP) Training

Location
Tarrytown, New York
Posted
Mar 20, 2018
Ref
10684BR
Discipline
Administration, Training
Required Education
Associate 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:
The Associate Director in Global Development's Training department serves in a Business Partner role and is responsible for driving the strategy and implementation of training for assigned functions within their business areas. This includes working with stakeholders from Clinical and/or Regulatory disciplines to translate business needs into plans for the design and delivery of effective training assets in accordance with ICH/GCP requirements and current training design methodologies (e.g., ADDIE). They will also manage general stakeholder training and support needs and identify requirements by interviewing, diagnosing, assessing risks, and making recommendations that result in improved overall workforce enablement. In addition, they will work with external partners (CROs) to ensure compliance with clinical trials training requirements.

Responsibilities:
Essential Functions required for the job. List both technical and managerial requirements if applicable.

• Accountable for understanding the business needs, priorities, and challenges of Global Development by establishing a strategy for delivering effective learning assets for its members.
• Work with groups such as Process and Procedures to propose training solutions that align with controlled document releases.
• Understand compliance regulations and how they affect retention of training materials and records in order to propose effective solutions in support of Global Development staff training.
• Accountable for assigning and overseeing colleagues' work to scope, develop, and implement learning assets.
• Provide oversight of CRO and other external partners to ensure compliance with training related items contracted through service agreements, charters, operating manuals, etc.
• Partner with HR and other company training colleagues to align on common objectives regarding learning and development.
• Build strong relationships with stakeholders to enable compliance with regulatory training requirements.
• Participate in cross-functional continuous improvement projects to ensure learner's needs are ultimately met with appropriate training aligned with project outcomes.
• Remain current with best practices in regulatory training, adult learning principles and styles, and technology enabled training solutions.
• Occasionally conduct training or learning sessions as well as plan and facilitate large and small sessions related to learning.
• Plan, prepare for, and participate in internal Quality Assurance audits of training, taking responsibility for response preparation and follow-up.

Supervisory Responsibilities:
• May oversee the work of vendors focused on developing and delivering training solutions.
• May oversee the LMS (Learning Management System) administration function for Global Development.

Requirements:
• BS/BA Degree with 10+ years relevant experience. MS degree and 8+ years relevant experience.
• Experience in the design, development, and delivery of training, specifically in a research or health care environment, is required.
• Experience working in a regulated environment, ideally clinical trial research, is strongly preferred.
• Proven ability to track deliverables through excellent organizational skills of project planning and managing supportive activities.
• Extensive knowledge of training methodologies and adult learning principles.
• Strong knowledge of ICH/GCP and regulatory requirements.
• Self-motivated, with the ability to work effectively in a dynamic and geographically diverse environment.
• Strong leadership with demonstrated ability to interface effectively with senior leaders and different levels of the organization.
• Excellent problem solving, written, and verbal communication skills.
• Ability to effectively manage multiple priorities with a sense of urgency.
• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.
• Attention to detail and accuracy of work.

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: 10684BR