Reference Number: JO-2004-449031
RA/REMS Co-ordination Manager
Rate: Negotiable
Job Type: Permanent
Location: Boston

Role: RA/REMS Co-ordination Manager
Location: Boston, US
Employment: Permanent, Full Time

Our client is a global bio-pharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. They are a growing commercial business with a significant development pipeline. This is a very important role in our clients governance, and maintenance of the U.S. Risk Evaluation and Mitigation Strategy (REMS) for two approved products.

Main responsibilities:
Generate and manage timelines associated with the maintenance of the REMS for both approved products
Liaise with vendors including the REMS coordination centre to execute on REMS activities
Manage contracts associated with REMS vendors
Assist as point of contact for REMS Management team
Working with the REMS Management Team Leader and Executive Sponsors, provide meeting coordination and facilitation to the REMS Management Team, REMS Executive Steering Committee
Heighten REMS implementation issues to the REMS Management team and Executive Steering Committee Chairs
Coordinate and attend REMS Management Team and REMS Executive Steering Committee meetings
Maintain accurate records of meetings, decisions, action items and correspondence associate with the REMS Governance
Support with the preparation and delivery of training programs and materials for REMS
Assist with the development, review and QC of REMS reports that are submitted to the FDA
Collect and organize metric data and other documentation from internal or external sources
Manage REMS projects, including project planning, budgets, vendors, communication
Support inspections and audits specific to REMS

Knowledge, Experience & Skills:
Eligibility to work in the US
B.S in health science required; advanced training PharmD, or equivalent preferred
2 years pharmaceutical industry experience in Risk Management, Regulatory, Clinical, Medical or equivalent
1-2 years of direct experience in REMS program management preferred
Excellent verbal and written communication skills
Excellent planning, organizational, problem solving, and time management skills
Proven ability to establish sound working relationships with colleagues cross functionally
Proven experience in group facilitation – ability to drive teams to make decisions & achieve deliverables
Self-motivated and able to handle multiple complex issues
Skilled with use of MS Word, MS Excel, MS Project, Visio
Thorough knowledge US REMS regulations and requirements

If you are interested in discussing this role further, then please email your CV to amani.yousef@regulatoryprofessionals.com or call Amani on 01189 522 797 to arrange a confidential discussion.

If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*.