Strategist, GRA CMC

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🕒 July 1

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Oversee regulatory affairs operations, balancing quality, timelines, and stakeholder expectations. • Developing and implementing regulatory strategies for global clinical trials. • Providing expertise and guidance on regulatory requirements and compliance issues. • Collaborating cross-functionally with teams to ensure regulatory objectives are met. • Leading interactions with regulatory agencies and preparing submissions. • Keeping abreast of regulatory updates and industry trends to inform strategy.

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry. • Strong knowledge of global regulatory requirements and guidelines. • Proven track record of successful regulatory submissions and interactions. • Excellent communication, leadership, and problem-solving skills.

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways