Director, REMS Technology

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

This critical role helps shape the future approach and content of technology solutions enabling the U.S. REMS programs, by (1) having a deep knowledge of the maturing and evolving U.S. Health IT environment, (2) aligning REMS technology investments with business needs and strategies, and (3) driving the delivery and support of technology solutions in partnership with and through Celgene’s IT organization.

Responsibilities include, but are not limited to the following: 

1.Health IT Awareness

a.Maintain a deep knowledge of the of U.S. Healthcare technology environment, and its potential business impact, through vendor and consulting interactions, conference attendance, and Celgene events/input 

b.Collaborate with other Celgene functions (e.g., IKU, Drug Safety, IT, Commercial) to understand their broader impact and use of technology,provide the U.S. REMS approach, and identify opportunities to share best practices

c.Represent Celgene at relevant Standard Development Organizations to ensure that REMS transactions can utilize appropriate standards

d.Prepare and maintain materials to explain the healthcare technology opportunities for REMS, and operate as a subject matter expert in thismanner

2.REMS Technology Strategy

a.Chair the U.S. REMS Technology Steering Committee (IT, U.S. REMS leadership, Commercial) to provide guidance and expert feedback on U.S. REMS technology directions and status

b.In collaboration with Celgene IT, maintain a master plan and roadmap for U.S. REMS technology solutions that meet business strategies, reflects the rapidly evolving healthcare ecosystem, and are aligned with Celgene’s IT vision

c.In collaboration with Celgene IT, Identify, evaluate and implement technology pilots to support the REMS 2020 vision 

3.REMS Systems

a.Lead the business governance activities required to support the delivery and maintenance of Celgene’s family of U.S. REMS systems.  This includes the business advisory and guidance role for the Change Assessment Board, and ensuring business priorities are clear and well communicated

b.Oversee the development of detailed business requirements for new system projects, and User Acceptance activities for systems implementations.

c.Manage the U.S. REMS technology finances are well managed, including maintenance, support fees, and capital investments 

d.Introduce, maintain, and report upon KPIs that illustrate the effectiveness of the U.S. REMS technology environment, identify improvement opportunities, and drive to implementation

e.Ensure that the U.S. REMS is able to demonstrate compliance with internal and external regulatory guidance regarding validation, privacy, and security U.S. REMS technology; working in collaboration with Celgene IT.

f.Business systems owner for all U.S. REMS technologies, except SupportPoint

g.Responsible for the Business Continuity Plan and Disaster Recovery Plan testing program

4.Reporting

a.Manage an internal team that utilizes corporate business intelligence technologies to produce regulatory and operational reports 

b.Continuously assess departmental needs, and prepare strategies to implement technologies that enhance operations, increase efficiencies and reduce costs

5.REMS Knowledge

a.Maintain a thorough understanding of FDA REMS regulations, and industry trends regarding the implementation of REMS

b.Ensure a comprehensive knowledge of REMS department operations, including all SOPs, work practices and systems

6.Department oversight and other tasks

a.Responsible for the development of the REMS Technology team, hiring, performance monitoring, development plans, improvement plans etc..

b.Responsible for the financial planning and execution of departmental activities according to agreed budget

c.Provide scheduled and ad-hoc reports to the leadership team as required

d.Other responsibilities as assigned

*LI-EX