SSU & Regulatory Specialist

Amsterdam (Gemeenten), Noord-Holland (NL)
31 Jul 2019
30 Aug 2019
Full Time
Experienced (non-manager)

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.

A career with Syneos Health means your everyday work improves patients’ lives around the world.

At Syneos Health we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.

As a member of our Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study. This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard.

We are currently looking to strengthen our Ethics and Regulatory department in The Netherlands and are seeking an experienced SSU & Regulatory Specialist with Site Contracts experience to be based in The Netherlands. You can work from our office in Amsterdam with a great view or work from home with regular visits to the Amsterdam office.

A brief summary of duties you will be involved in as a Site Start up and Regulatory Specialist:

- Reviewing essential document packages for site activation
- Preparation and submitting of Central EC Applications, Local EC Applications, - RA Applications, and other local regulatory authorities or hospital approval submissions as required
- Reviewing Informed Consent Forms
- Negotiating terms and budget of the contract with Investigator Sites

To succeed in this role you will need the following skills/experience:

  • Previous experience in clinical research including submissions experience and site contract negotation

  • Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive as well as any applicable rules applicable locally.

  • Fluency in Dutch and English.

Are you interested to join us?

You may directly apply online or reach out to one of our dedicated Benelux recruiters Eveline Wigtman or Irene Houtsma  and we would be more than happy to speak with you.