Senior Manager/Associate Director, Case Management Oversight/Medical Review Lead
Company: Agios Pharmaceuticals Inc
Location: Cambridge
Posted on: April 5, 2021
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Job Description:
Senior Manager/Associate Director, Case Management
Oversight/Medical Review Lead Location Agios Pharmaceuticals HQ Job
Code 1473 # of openings 1 Senior Manager/Associate Director, Case
Management Oversight/Medical Review Lead, Medical Safety & Risk
Management Agios (agios.com) is a biopharmaceutical company
committed to applying our scientific leadership in cellular
metabolism to transform the lives of patients with cancer and rare
genetic diseases. We are growing rapidly with an active research
and discovery pipeline across both therapeutic areas. Agios has two
approved oncology precision medicines and multiple first-in-class
investigational therapies in clinical and/or preclinical
development. Agios Pharmaceuticals is searching for a dynamic Case
Management Oversight/Medical Review Lead to join our Medical Safety
& Risk Management (MSRM) team. This position is a role that bridges
safety case management and report submissions oversight with safety
surveillance/risk management. The successful candidate will
effectively interface, cross-functionally, at all levels of the
organization as well as externally with business partners and
vendors, ensuring alignment with contractual agreements, company
policies, ICH guidelines and global regulations throughout the
product lifecycle. The individual in this role is also responsible
for providing direction and training to internal staff and
third-party vendors. The ability to work in a dynamic, changing
environment in order to meet corporate goals and patient needs is
essential. The Case Management Oversight/Medical Review Lead
reports to the Director of MSRM Case Management and serves as a
point of contact for the medical review and case processing teams,
for investigational and marketed products. The person in this
position possesses significant knowledge of case processing,
inclusive of medical review, and report submissions in order to
ensure timeliness and quality of Agios' individual case safety
reports and will be responsible to perform Quality Control review
of the vendor's work and provide feedback directly to the vendor.
The person in this position will also participate in or lead
special projects, represent MSRM Operations on Clinical Trial
Working Groups, and be an expert resource for all aspects of safety
case management and medical review to develop and support the
safety profiles of all Agios products. Key Responsibilities
Keywords: Agios Pharmaceuticals Inc, Cambridge , Senior Manager/Associate Director, Case Management Oversight/Medical Review Lead, Executive , Cambridge, Massachusetts
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