Regulatory Specialist II
2 weeks ago
About the Role
Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
As a Site Start-Up & Regulatory Specialist II, you will play a critical role in ensuring the quality of our clinical trials. You will be responsible for managing the start-up process, including site selection, feasibility, and contract negotiations. Your attention to detail and organizational skills will be essential in ensuring that all regulatory requirements are met.
Key Responsibilities
- Manage the start-up process for clinical trials, including site selection, feasibility, and contract negotiations.
- Ensure compliance with regulatory requirements, including ICH GCP and local regulations.
- Collaborate with cross-functional teams to ensure timely and successful trial execution.
- Develop and maintain relationships with sites, investigators, and other stakeholders.
- Provide training and support to sites on regulatory requirements and clinical trial procedures.
Requirements
- Bachelor's degree in a relevant field.
- Minimum 2 years of experience in clinical trials or regulatory affairs.
- Strong knowledge of ICH GCP and local regulations.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
What We Offer
Syneos Health offers a dynamic and supportive work environment, with opportunities for professional growth and development. We are committed to diversity, equity, and inclusion, and strive to create a workplace that is welcoming and inclusive for all employees.
Why Syneos Health
At Syneos Health, we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
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