[Hiring] Clinical Trial Regulatory Advisor @Syneos Health

Role Description

The position is to work with submissions in Canada - Argentina Home Based.

Provides regulatory and technical support for assigned Regulatory work:

• Review and finalization of essential core documents required for site initiation regulatory and core submissions performance (if applicable) from site startup until study end related submissions.
• Accountable core regulatory activities; including the agreed regulatory submission strategy and ensures tasks are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.

Responsibilities:

• Perform the CTRA operations deliveries on specific project activities which may include in particular regulatory leading function which result in client satisfaction.
• Review clinical trial study core documents (such as labelling for regulatory compliance etc.).
• Contribute to and prepare the technical components of a regulatory core submission (such as EU Clinical Trial Regulation Part I and/or II).
• Contribute to or support with any agency interactions.
• Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
• Act as a subject matter expert and help the team members with day-to-day troubleshooting activities, presenting solutions to project-related problems.
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
• Identify and report on areas of process and risk.
• Ensure personal compliance and/or accuracy with relevant quality standards.
• Consistently achieve and maintain utilization target and departmental goals.
• Maintain current knowledge of applicable regulations and guidelines.
• Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products.
• Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.

Qualifications

• Minimum of a BA or BS preferred.
• Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc.
• Excellent presentation, documentation, influencing, and interpersonal skills (both written and spoken English) as well as a team-oriented approach.
• Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet are necessary.

Requirements

• 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.

Company Description

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.