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We are looking for a driven Senior Local Compliance Specialis t to be located in Breda, the Netherlands.
In this role you will join our Compliance team in Belgium and The Netherlands but also supporting the local compliance team in The Nordics (Sweden, Denmark, Norway and Finland). You will contribute to a coordinated and comprehensive local quality and compliance approach to ensure our clinical trials will be delivered to the highest quality standards and are following all applicable SOP’s, laws and regulations. Our new colleague should be flexible, persistent and able to work independently. We are seeking to hire a strong communicator, a team player and someone with analytical skills, with quick learning and problem-solving abilities. The Senior Local Compliance Specialist will collaborate with the Compliance Managers, the Country Head, the Clinical Research Managers and the local teams in the Northern European cluster, carrying out the clinical trials, consisting of Local Trial Managers (LTM), Site Managers (SM) and Clinical Trial Assistants (CTA). You will be part of a hardworking, enthusiastic, and committed team to deliver and helping to improve the lives of millions of patients.

EDUCATION AND EXPERIENCE REQUIREMENTS:

• BA/BS degree in Life Sciences or related scientific field (or minimum 4 years equivalent experience).
• A minimum of 3 years of previous pharmaceutical industry experience is required with at least 2 years of GxP experience within clinical research and/or quality assurance. Other relevant working experiences and skills may be considered by the hiring manager. Experience in phase 1, 2, 3 clinical trials is a plus.
• Good working knowledge and proven understanding of GCP, local laws, and regulations
• Developed knowledge of business processes and practices
• Ability to present in a clear and concise way - strong communication skills
• Strong interpersonal and negotiation skills and ability to empower colleagues and stakeholders
• Real diplomate that can understand impact and complexity of the situation, with the ability to create win-win situations
• Willingness to engage with Authorities and key site staff
• Proficient in Dutch and English

• Compliance Oversight: Proactively monitor compliance risks and metrics and install timely mitigation actions; Contribute in implementing local quality plans; Perform on-site compliance monitoring visits, supervise progress and confirm efficiency of remediation plans and conduct QC checks on trials and processes; support preparation and oversight of inspections and audits and timely implementation of CAPA’s; leads or provides input in process improvement initiatives.
• Onboarding and consultation: support onboarding of new hires; coordinate workshops, trainings and lessons learned on local and Northern European cluster level to increase compliance awareness. Be the go-to person for risk management and provide advice to ensure timely resolution of issues.
• Local regulatory intelligence: perform impact assessments of new/revised local regulations and provide clear and timely guidance to the teams. Keep local intelligence up to date.
• Collaboration with business quality: support in local supplier assessments, assist with annual due diligence update, certification and training of local suppliers.
• Co-host cluster and regional compliance meetings.
• Assume additional responsibilities or special initiatives such as ‘Champion’ or ‘Subject Matter Expert’.