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Regulatory Specialist II

2 months ago

Montreal, Quebec, Canada Syneos Health Full time
Job Title: SSU & Regulatory Specialist II

About the Role

We are seeking a highly skilled SSU & Regulatory Specialist II to join our team at Syneos Health. As a key member of our team, you will be responsible for ensuring the quality of our clinical trials and regulatory submissions.

Key Responsibilities

  • Responsible for the quality deliverables at the country level, following project requirements and applicable country rules with moderate oversight from the SSU Country Manager.
  • Works within forecasted submission/approval timelines and ensures compliance with and tracks milestone progress in agreed-upon SSU tracking systems in real-time.
  • Monitors basic financial aspects of the project and the number of hours/tasks available per contract, escalating discrepancies in a timely fashion.
  • Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeping training records updated accordingly and ensuring timesheet compliance.
  • Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned.

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
  • Good negotiating skills
  • Good problem-solving skills
  • Demonstrated ability to work independently as well as part of a team

Language Requirements

Must be fluent in French

About Syneos Health

At 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.