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I inspire changes and build bridges in the dynamic Pharma/Medical Device and Biotech industry and bring efficient solutions monitoring & navigating…Job Title: Start-Up and Regulatory Associate – Real-World Evidence (RWE) Studies
Location: Austria (Local/Remote Flexibility)
Employment Type: Full-Time
About Poseidon CRO:
Poseidon CRO is a leading clinical research organization specializing in Late phase ( IIb& III ) clinical development, Real-World Evidence (RWE) studies, pharmacoepidemiology, and patient support programs. With over 15 years of experience in clinical research, we provide tailored solutions to pharmaceutical, biotechnology, and medical device companies across Europe and beyond. We are currently expanding our RWE capabilities in Austria and seeking a detail-oriented and proactive Start-Up and Regulatory Associate to join our team.
Your Role:
As a Start-Up and Regulatory Associate, you will be instrumental in managing the regulatory and start-up activities for RWE studies in Austria. You will collaborate with cross-functional teams, including clinical operations, legal, and quality assurance, ensuring compliance with Austrian and EU regulatory requirements.
Key Responsibilities:
- Prepare, submit, and maintain regulatory documents required for RWE study approvals in Austria.
- Liaise with ethics committees, regulatory authorities, and stakeholders to ensure compliance with national and EU regulations.
- Oversee start-up activities, including site identification, feasibility assessments, and contract negotiations.
- Maintain and update regulatory documentation, including study protocols, informed consent forms, and investigator brochures.
- Provide regulatory guidance to internal teams and external partners, ensuring adherence to local and international regulatory frameworks.
- Monitor and communicate regulatory changes that may impact RWE studies.
- Support the development of strategies to mitigate regulatory challenges and ensure timely study initiation.
What We're Looking For:
- Bachelor's or Master's degree in life sciences, regulatory affairs, or a related field.
- Minimum of 2 years of experience in regulatory affairs, clinical trial start-up, or a similar role, preferably in RWE or observational studies.
- Strong understanding of Austrian and EU regulatory requirements for clinical research.
- Experience working with ethics committees and regulatory authorities in Austria.
- Excellent organizational skills with a keen eye for detail.
- Strong communication and interpersonal skills, with the ability to work in a dynamic and fast-paced environment.
- Fluency in German and English (both written and spoken).
Why Join Poseidon CRO?
- Be part of a growing CRO with a strong reputation in RWE studies and clinical research.
- Opportunity to contribute to impactful research that improves patient outcomes.
- Collaborative and supportive work environment with professional growth opportunities.
- Competitive salary and benefits package.
- Flexibility to work home-based and on the field.
How to Apply:
If you are excited about the opportunity to support innovative RWE studies and regulatory processes, we would love to hear from you Please send your CV and a brief cover letter to jobs@poseidoncro.com with the subject line "Start-Up and Regulatory Associate Application – AT REG02-25"
Application Deadline: 14.02.2025.
Start Date: Immediately
Join us in advancing clinical research and shaping the future of Real-World Evidence studies
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