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Sr. Director Risk Management

Company Name:
Regeneron
Job Summary and Essential Functions:
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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
(This position can be in Tarrytown, NY or split between Tarrytown and Basking Ridge)
Summary:
Responsible for comprehensive risk management of investigational and marketed products in accordance with global regulations and Regeneron Standard Operating Procedures and working practices. Responsible for management of RM group and all its deliverables. In collaboration with the Head of PVRM, responsible for developing and executing a vision for the RM group. Responsible for comprehensive risk management system for risk detection, risk assessment, and risk minimization for investigational and marketed products, including oversight of medical review of adverse events.
Responsibilities:
Leadership responsibility for Risk Management group, with active participation in activities as needed
Supervises and, as needed, assumes lead role in preparation and finalization of all Risk Management regulatory documents including and not limited to PSURs/ DSURs (Periodic/ Development Safety Update Reports), RMPs (Risk Management Plans), REMS (Risk Evaluation and Mitigation Strategy).
Represents Risk Management and provides recommendations on Risk Management strategies and activities at meetings with senior management (internal and partnerships). Represents Risk Management at meetings with regulatory authorities (US and ex-US).
Manages and develops Risk Management staff, including quality standards, adequacy or training, job performance and career development.
Maintains knowledge of US and international pharmacovigilance requirements. Oversees development and maintenance of Risk Management SOPs and working practices.
Represents Risk Management in relevant internal/external committees. May be a key participant in Development or Steering Committees.
Regularly interacts with Sr. Management or Executive levels on matters concerning the program strategy.
Experience and Required Skills:
Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
Subject matter expert on various aspects of Risk Management.
Supervisory experience of senior level staff (up to level of Associate Director/Director).
Experience leading RM activities across entire product lifecycle.
Medical Degree (board certified preferred) with additional training in epidemiology or public health preferred.
Minimum years of experience:
Minimum of 10 years of risk management experience in pharmaceutical/biotech industry, including interactions with Health Authorities, with 2-3 years of direct RM personnel management experience.
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 Regenerons 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, disability status, protected veteran status, or any other characteristic protected by law.
Apply online at:
http://careers.regeneron.com/basking-ridge/clinical-data-management/jobid4433019-sr.-director-risk-management-jobs

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