Senior Research Analyst, Quality and Compliance (Pharmaceutical, Biotech)

POLITICO • Arlington, VA

1d • Onsite

About The Position

POLITICO is seeking a Senior Research Analyst to help lead part of its regulatory intelligence and information services product, AgencyIQ. Since its founding in early 2020, AgencyIQ has quickly become the premier source of regulatory intelligence and analysis for professionals working in the life sciences, foods and chemicals industries. Our written research and analysis are relied upon by many top companies, trade groups, law firms and advocacy groups to help them understand breaking news, identify emerging trends, predict future action and prepare for seismic shifts in regulatory policy. As a subject matter specialist in the regulation of drug product quality (including pharmaceuticals, biopharmaceuticals and biotechnology products) and compliance topics related to the U.S. Food and Drug Administration (FDA) and other key global regulators, the Senior Research Analyst will be responsible for analyzing the relevance of regulatory changes and developments, tracking and identifying trends in FDA compliance on regulated products, articulating the type and degree of impact on industry, and providing context to an audience of knowledgeable regulatory professionals. Reporting to the Senior Director for Life Sciences Research in POLITICO’s Arlington, Virginia offices, the Senior Research Analyst will join a team of experienced researchers responsible for producing a mix of daily written content, in-depth written research, weekly insights, directed deliverables and presentations. Expected areas of subject matter coverage will include regulations, guidance, international standards, legislation, announcements, FDA enforcement and compliance trends, and current good manufacturing practice-related developments.

Requirements

• At least 3 years’ experience analyzing FDA regulatory policies at a consulting company, think tank, trade association, government agency, life sciences company, or media outlet with an emphasis on quality regulations
• An affinity for writing – efficiently and effectively, and for a business or policy audience – paired with a knowledge of (and passion for) regulation and regulatory policy
• Experience and comfort working in fast-paced, research-driven environments in which daily delivery of written regulatory analyses is the norm
• Experience with qualitative and quantitative analysis and trend tracking
• A good working knowledge of FDA regulatory processes (and in particular those related to drugs and biotechnology products) and familiarity with FDA’s compliance systems and databases; capable of delivering expert insights to our knowledgeable subscribers

Nice To Haves

• Have an advanced degree or certification related to the life sciences (i.e., a PhD, relevant master’s degree, or J.D.)
• Have prior experience working in media, including as a journalist or writing a product widely read by others (i.e., a business intelligence product or internal newsletter)
• Have experience in quantitative analysis using FDA data sets
• Experience presenting on regulatory topics to a variety of different audience types (small groups, large groups) in different environments (virtual and in-person)

Responsibilities

• Produce daily (3-4 per week) topical intelligence articles and other content for our subscribers based on emerging regulatory and legislative developments related to the FDA’s regulation of drug quality and other closely related topics
• Serve as a subject matter specialist on matters of drug quality and compliance
• Lead or participate in the development and delivery of in-depth analysis, deep-dive research, webinars and email newsletters
• Participate in subscriber- and prospect-facing events, and briefings

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed