Sponsor Dedicated Start Up & Reg Specialist II/Sr, Hybrid - Based in Kfar-Saba

Description

Sponsor Dedicated Start Up & Reg Specialist II/Sr, Hybrid - Based in Kfar-Saba

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why 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.
  
  

Job Responsibilities

The position will be mainly office based at Sponsor's offices in Kfar-Saba.

As an experienced Start-Up Specialist, you will play a vital role in clinical research. You will manage start-up activities for clinical trials, ensuring compliance with local regulations, good clinical practice, Sponsor procedures, and protocol requirements. Your work will focus on delivering reliable data and protecting study participants as you activate trial sites before the first patient visit in the country. Additionally, you will be responsible for executing regulatory submissions, including clinical trial applications, and ensuring timely approvals.

In Addition, You Will

• Prepare and submit Clinical Trial Applications to Health Authorities and Ethics Committees, ensuring compliance with local regulations, trial protocols, and applicable guidelines
• Follow up on submissions until approvals are obtained, and collaborate with teams to answer queries and provide necessary documentation
• Maintain effective communication with Health Authorities and Ethics Committees, ensuring all trial team members are informed of submission status and timelines
• Manage document translations and approvals, including Clinical Trial product labels and directions for use
• Ensure timely updates in the Regulatory platform, maintain confidentiality, and comply with company policies and regulatory requirements.
  
  

We’re looking for an experienced detail-oriented individual who thrives in a team environment and is eager to collaborate with others. You should bring drive and motivation to your work, always taking initiative to learn and grow.

In Addition, You Should Bring

• Bachelor’s degree in a life science field, pharmacy, nursing, or a related qualification
• Basic GCP qualification
• Min 2 years of experience in start-up activities, whether in roles like start up specialist, clinical study coordinator (submissions to MoH/EC), or other clinical trial regulatory submission roles
• Fluency in written and spoken Hebrew and English
  
  

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.