Senior Study Start Up Associate- Regulatory Affairs

Regulatory Affairs Expert-IND Submission-CMC-Home based-South Korea-ICON Strategic Solutions ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Senior Study Start Up Associate at ICON, you will be working within a large-scale, fast-paced environment, supporting the Study Start Up Team Lead in developing and execute the plan for country and site distribution.

What You Will Do:

You will lead on site start-up and activation tasks requiring technical depth, with a focus on quality and continuous improvement.

Key responsibilities include: Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities. Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success. Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines. Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

Your Profile:

You will have a strong foundation in site start-up and activation, with the experience to work independently and guide others.

Required qualifications and experience: A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline. At least 3 years of experience or understanding of clinical study start-up requirements and activities, showing your expertise in the field. Fluency in the local language and English is essential, enabling you to effectively communicate and collaborate with international teams. IND Submission and CMC Specialist

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include: 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request  here .

Are you a current ICON Employee? Please click here to apply