Director, Global Risk Management Standards - United States
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- Our company 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.
- Reporting to the Head of Risk Management, the Director Risk Management Standards ensures incorporation of our company core risk management principles and standards in the development and implementation of the company’s proprietary risk management programs (RMPs) worldwide.
- The position is also responsible for:
- Guiding local company offices & business partners in development, implementation and maintenance of country-specific RMPs Providing RM medical leadership as part of life-cycle management
Responsibilities will include, but are not limited to, the following:
- Appropriate management of Risk Management Standards information and processes, and in particular the medical aspects
- Designing regional/local RM programs, incl. NPP support
- Chairing cross-functional RM teams and providing specific medical interpretation
- Liaising with multi-function company teams worldwide to oversee and uphold a consistent framework for risk management standards
- Maintaining awareness and tracking global RM regulatory environment & assessing impact
- Contributing to the periodic review of affiliate risk program performance
- Contributing to regional/local RM audit preparation and GAP-analysis
- Acting as a SME on RM standards to support regulatory inspections
- Drafting RM sections of the CCDS
- Collaborate with clinical R & D and Medical Affairs and be accountable for drafting RM text for relevant RM sections of clinical protocols
- Developing the RMP template for CTD Module I / regulatory submission
- Reviewing risk documentation in target PI/label draft (EU SmPC and affiliate label)
- Determining the RM content and core RM definitions applicable throughout the development program
- Creating key RM messages for core healthcare professional brochures and patient brochures, and proposing updates
- Contributing to the development of Proposed US REMS and supporting REMS documents as needed
- Contributing to the development of risk management tools and the assessment of RM tools performance worldwide
- Conducting scientifically/medically robust root-cause analysis for risk management outcomes of interest
- Accountable for intake, evaluation, drafting and reviewing RM inquiries of a medical nature
- Representing the risk management function at both internal and external meetings as required
- Provide input for global positioning on risk management to support Lead Safety Physicians
- Providing RM input to support other company functions (Regulatory, Legal, Marketing, Corporate communication etc.)
- Promoting RM scientific and operational excellence internally and with third-party business partners
- Accountable for the scientific/medical oversight on risk (requiring add. Risk Min. Tools), strategic input on Risk presentation in RMP documents, and the design of risk mitigation strategies
- Coordinate the development of RM-related protocols, to monitor compliance and effectiveness of Risk Minimization measures e.g. pregnancy programs 25% Travel required
- Education: MD (or international equivalent) with considerable industry experience in risk management/drug safety
- Experience: 6 + years of industry experience either in a clinical or a safety-related role; knowledge of Good Pharmacovigilance Practices (GVP), FDA REMS regulations and guidelines, and applicable international RM regulatory requirements; experience working on global and complex risk management programs or similar post-marketing programs
- Critical thinker, intellectually creative and with ability to synthesize, analyze and critique data
- Strong communication skills (oral and written) and the ability to interact with all levels of management and the ability to influence processes across multiple functions and geographies
- Solid experience in a rapidly expanding multinational environment.
- Our company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
- Our company complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for our company in the U.S.