Snr Manager - Risk Management - Drug Safety
Edison-New Brunswick Metro Area, NJ
- Senior Manager for Global Risk Management.
Preparing and updating risk management plans (e.g. REMS, EU-RMPs) for product submissions including NDA and sNDA submissions and marketed products for approved indications for maintaining RMPs globally.
Maintenance and update of RM electronic repository.
Lead project management to development, update and maintenance of product RMPs and support localized RMPs as requested by Senior Director.
Participate in cross-functional RM teams as needed.
Drafting responses for list of questions received by Regulatory Agencies as needed in support of NDS, MAAs or sNDA/Type II Variations submissions.
Participate in drafting response to inquiries pertaining to RMPs.
Assist with the coordination of development of appropriate RM processes (e.g. SOPs, WPs).
BA/BS in health-related discipline, MS preferred.
5 years of industry experience either in a clinical or safety-related role
3+ years in risk management and/or writing Europe Risk
Management Plans or other equivalent regulatory documents
Previous experience working within a comprehensive risk
management program is desirable.
Must be process improvement leader in cross-functional capacity and systems development experience is required
Extensive knowledge of clinical trials and drug development
Knowledge of commercial drug environment for risk management products
Understand safety data