Submission specialist - The Netherlands

Syneos Health, Inc.; Hoofddorp; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

Syneos Health is seeking a Submission specialist to support country-level regulatory submissions in the Netherlands. This hybrid role requires 2–3 days in the Hoofddorp office, with remote work available.

You will ensure timely local EC/RA submissions, maintain TMF documentation, monitor timelines, and liaise with country start-up advisors. Fluent Dutch and English, strong organizational and communication skills are essential.

Qualifications

• Bachelor’s degree in a relevant field.
• Fluency in Dutch and English.
• Experience with regulatory submissions and TMF processes.
• Strong written and verbal communication plus organizational skills.

Responsibilities

• Manage local and central regulatory submissions (EC/RA) for the country.
• Ensure timely submission timelines and maintain SSU tracking records.
• Review and compile essential documents for site activation and regulatory filings.
• Coordinate with CSAs, SAMs and PMs to support start-up activities.
• Maintain TMF quality and documentation, and assist in process improvements.

Skills

Dutch & English fluency

Regulatory submissions

Strong communication

Budget management

Organization

Vendor management

Problem-solving

Education

Bachelor’s Degree

Job description

## Submission specialist - The NetherlandsApply: Remote (Pre-Approved): NLD-Client: Full time: Posted Today: 25113129Submission specialist - The NetherlandsSyneos 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**For one of our single sponsor partnerships we will be looking for a submission specialist to join the team. This is a hybrid role with 2-3 days per week in the Hoofddorp office. * Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.* Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.* Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.* Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).* Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.* Responsible for the Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAM. May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects. Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager.* May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level.* Country Start-Up Advisor - Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications. In absence of legal advisor or dedicated subject matter may provide support for data protection at the country and provide guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This may include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template. Provides input in local SOPs and WI. Supports the creation of internal training materials on local legislation requirements. Provides input to the team to assist with EC or CA issue resolution at the country level. Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.* May be asked to perform: Local Investigator Contract and Budget Negotiator – Provides support to SAM to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site. Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SAM with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. We are looking for a colleague with the following qualifications: * Bachelor’s Degree,* Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.* Ability to understand clinical protocols and associated study specifications.* Detailed understanding of clinical trial start-up processes.* Ability to manage external vendors to contract effectively.* Strong organizational skills with ability to handle multiple tasks effectively.* Strong written and verbal communication and interpersonal skills.* Ability to manage multiple project budgets with increased complexity and value.* Quality-driven in all managed activities.* Fluency in Dutch and English* Good negotiating skills.* Good problem-solving skills.* Demonstrated ability to work independently as well as part of a team.