LM/19003901

SSU and Regulatory Specialist I

Office Based - Farnborough

Permanent

Here at Syneos Health, we are currently looking for an SSU and Regulatory Specialist to join our Country SSU team.

Job Details:

Your role as an SSU and Regulatory Specialist would include the following responsibilities:

• General – Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with 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 provides clear rationale for delays, assists with 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 (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Responsible for one or more of the following functions at the country level:
• Local Submissions Specialist
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision.
• Local Site ID and Feasibility Support
• Local Investigator Contract and Budget Negotiator

Eligibility/Qualifications/Requirements

The ideal candidate will need the following experience / skills to be considered:

• Associate’s Degree or equivalent combination of education and training.
• Good understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel.

• Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
• Ability to take direction from multiple individuals and set priorities accordingly.
• Ability to effectively communicate across multiple function groups (clinical team, PM, Director).
• Demonstrated ability to work independently, as well as part of a team. Utilize problem-solving techniques effectively.
• Quality-driven in all managed activities.
• Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.
• Strong computer skills, including Word, Excel, PowerPoint, Publisher.

We have a comprehensive benefits package and offer highly competitive remuneration.

If you have the required experience for this position and are eligible to work in the required location then please apply through our online application.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

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.

Disclaimer:
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. #LI-LM1