Syneos Health Is Hiring A Sponsor Dedicated Start Up & Regulatory Specialist II/Sr - Based in Kfar-Saba

Join Syneos Health as a Sponsor Dedicated Start Up & Regulatory Specialist II/Sr based in Kfar-Saba and be at the forefront of innovative clinical research that makes a real impact worldwide. 🌍

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate clinical, medical affairs, and commercial insights into tangible outcomes to address the evolving realities of the market.

Our Clinical Development model centers on the customer and the patient, always striving to simplify and streamline processes. Whether partnering as a Functional Service Provider or operating in a full-service environment, our passionate teams innovate together to help our clients achieve their goals. We are agile, driven, and passionate about changing lives.

Discover why 29,000 employees across 110 countries agree: WORK HERE MATTERS EVERYWHERE ✨

Why Choose Syneos Health?

• Career Growth: We foster professional development through training, career progression, supportive management, and recognition programs.
• Authentic Culture: Embrace our Total Self culture—where you can be genuine and true to yourself. We prioritize taking care of our people.
• Diversity & Inclusion: Building a workplace rich in diverse thoughts, backgrounds, and perspectives to ensure everyone feels they belong.

Job Responsibilities

The role is primarily based at the Sponsor's offices in Kfar-Saba.

As an experienced Start-Up Specialist, you will be a key player in clinical research, managing start-up activities for clinical trials while ensuring compliance with regulations, good clinical practice, Sponsor procedures, and protocol standards. Your efforts will focus on delivering reliable data and safeguarding study participants by activating trial sites before the first patient visit in the country. You will also handle regulatory submissions, including clinical trial applications, ensuring approval timelines are met.

In addition, you will:

• Prepare and submit Clinical Trial Applications to Health Authorities and Ethics Committees, ensuring compliance with local regulations and guidelines.
• Follow up on submissions, collaborating with teams to answer queries and provide necessary documentation.
• Maintain effective communication with authorities, keeping the trial team informed of submission statuses and timelines.
• Manage document translations and approvals, including product labels and directions for use.
• Ensure timely updates in regulatory platforms, uphold confidentiality, and adhere to internal policies and regulatory standards.

Ideal Candidate Profile

We seek a detail-oriented, team-spirited individual who is motivated to learn and grow, bringing initiative and a proactive mindset to work.

Required Qualifications:

• Bachelor’s degree in a life science, pharmacy, nursing, or related field
• Basic GCP qualification
• Minimum of 2 years experience in start-up activities (e.g., start-up specialist, clinical study coordinator, or similar roles involving regulatory submissions to MoH/EC)
• Fluent in both Hebrew and English, written and spoken

Discover More About Syneos Health

Over the past five years, we've collaborated on 94% of FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites involving 675,000+ trial patients.

In any role, you'll be encouraged to innovate, challenge the status quo, and thrive in a competitive, constantly evolving environment.

Learn more at our website 🚀

Additional Information

The responsibilities listed are not exhaustive, and the company may assign additional tasks at its discretion without prior notice. Equivalent experience and skills will be considered. This description is not a contract of employment. We comply with applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations when needed.