Clinical Trial Regulatory Specialist, based in Serbia

Clinical Trial Regulatory Specialist, based in Serbia

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

With supervision, performs assigned activities within the CTRA team. Responsible for providing delivery and expertise, in one or more of the following functional areas: 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 are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.

For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues.

• Prepare the technical components of a regulatory core submission (such as EU Clinical Trial Regulation Part I and/or II). Support with any agency interactions.  With supervision, compile and perform regulatory core submission (such as EU Clinical Trial Regulation Part I and/or II)
• Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.
• Attends client meetings as needed and builds client relationship in support of projects and deliverables
• Identifies and reports 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
• Maintains current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products
• Other Responsibilities:
• 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.
• Ability to travel as required (approximately 10%)

• QUALIFICATION & REQUIREMENTS
• 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) as well as a team-oriented approach.
• Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet are necessary

Get to know Syneos Health

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. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

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.