As a member of the U.S. Regulatory Policy and Global Regulatory Intelligence group, this role’s primary responsibility is to partner with Worldwide Safety & Regulatory (WSR) therapy area leadership by providing strategic regulatory analysis and the necessary systems and tools to inform product team decisions and to provide WSR and Pfizer with a competitive advantage. A career at Pfizer offers opportunity, ownership and impact.
Analysis & Reporting
Provide strategic regulatory intelligence analysis to inform decision-making, including in response to ad hoc queries from product teams, therapy area leads, and other stakeholders.
Prepare periodic regulatory intelligence reports that analyze the strategic significance of recent past and forthcoming regulatory events and their potential impact on the Pfizer portfolio.
Analysis is expected to be interpretive, to provide context and novel insight, and to go beyond merely gathering and organizing information.
Systems & Processes
Develop a working knowledge and understanding of relevant systems such as the internal Global Regulatory Intelligence News, the internal Regulatory Intelligence website, and other internal and external tools, and leverage these tools to create, distribute and archive industry leading deliverables.
Lead or participate as assigned, in routine evaluations of new information sources and tools, (e.g. dashboards, databases, machine learning, artificial intelligence, repositories), looking for both content usefulness and toward automating the process of collecting, analyzing, disseminating, and archiving of regulatory intelligence for additional use.
Lead or participate in system and process improvement/implementation activities as assigned.
Collaboration
Collaborate with therapy area regulatory leads, regulatory strategists, regulatory policy & intelligence colleagues, and other Pfizer stakeholders to support policy activities at the product, category area, and enterprise level.
Partner with regulatory teams to identify opportunities to accelerate development by leveraging novel regulatory approaches while mitigating risks.
Collaborate with other internal intelligence and policy organizations to provide context and broader perspective to increase the value of deliverables.
Establish and leverage internal and external networks to gather intelligence and insight that is not available from published sources.
Prioritization - In collaboration with therapy area regulatory leadership, create key intelligence priority lists that will drive specific upcoming intelligence activities (collection and analysis).
Horizon Scanning to Inform Teams
Systematically monitor the numerous Pfizer and publicly available information systems to collect and disseminate relevant, focused regulatory intelligence alerts and analysis on emerging issues and relevant events.
QUALIFICATIONS
Education and Experience:
• Minimum BA / BS in a scientific discipline, with an advanced degree preferred.
• Minimum of 12 years of life science experience:
With at least 8-yrs in the regulatory field, that includes substantial experiences in product teams and interacting with Health Authorities.
Experience/knowledge in >1 region, and experience in an intel/policy/analyst role is beneficial.
Demonstrable knowledge of the drug lifecycle (research, development and commercial) process, and how the external environment can shape regulatory outcomes.
Technical Skills:
Strong analytical skills.
Strong written and verbal communication skills, including the ability to interact effectively and to influence more senior leaders.
Strong problem solving skills (e.g. issue identification, method/tool selection)
Ability to effectively navigate, identify, extract, analyze, and communicate targeted intelligence from a wide range of external sources (e.g. subscription databases, health authority websites, etc.).
Demonstrated abilities to perform strategic work.
Strong attention to detail.
Competent posting to, organizing, and retrieving material from wide range of databases and web-based tools; proficiency in archival information systems (e.g. Sharepoint)
Ability to evaluate utility of external resources for collecting regulatory & safety intelligence.
Customer focused and adaptable, with the ability to seamlessly balance and manage multiple projects from multiple stakeholders to time and quality.
High functioning as both a team player and individual contributor.
Ability to work effectively with Pfizer's internal and external vendors of information.
An understanding of applied principles of information storage and management including the use of internet/intranet based solutions.
A writing sample may be required
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