Regulatory and Compliance Lead

2 days ago

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PicnicHealth

WebsiteLinkedInAll Job Openings

Medical Records • Healthcare IT • Machine learning • Artificial intelligence • Life Sciences

51 - 200 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

☁️ SaaS

💰 $60M Series C on 2022-06

Description

• PicnicHealth is revolutionizing how life sciences companies advance medicine while providing immediate value to the patients who power the research. • Founded in 2014, PicnicHealth partners with 12 of the top 20 biopharma companies and has raised over $100 million in venture capital. • As Regulatory & Compliance lead, you’ll ensure that our decentralized trials and observational research meet the highest standards of regulatory compliance and quality. • Develop and maintain a robust Quality Management System (QMS), shape regulatory strategies, oversee risk management, conduct audits, and validate our technology platform. • Your expertise will guide our teams and partners through the evolving regulatory landscape, fostering innovative, fit-for-purpose solutions that align with our commitment to scientific excellence and patient-centered care.

Requirements

• Extensive experience (8+ years) in clinical trial regulatory affairs and quality assurance, with a strong track record in helping build and evolve systems in a rapidly growing company. • In-depth knowledge of global regulatory requirements (GCP, ICH, 21CFR11, FDA guidance, etc.) and quality management principles (e.g., ICH Q9). • Proven ability to develop and implement effective regulatory and quality strategies for decentralized trials and/or observational research. • Have led technology validation and compliance programs. • Excellent leadership and communication skills, with the ability to inspire, motivate, and build consensus across diverse teams. • A strategic, business-oriented thinker who can bring a keen understanding of risk management and mitigation strategies to weighing quality, regulatory, legal, and business risks. • A passion for innovation and a commitment to scientific excellence. • Have experience working in a start-up environment with a focus on both technical and scientific excellence and an entrepreneurial spirit and are seeking a high-growth, fast-paced environment where you can innovate and help build a disruptive business.

Benefits

• Comprehensive benefits including above market Health, Dental, Vision • Family friendly environment • Flexible time off • 401k plan • Free PicnicHealth account • Equipment and internet funds for home office set up • Wellness Stipend