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Sr Clinical Trial Specialist (Sr Global SSU Submission Specialist) - Serbia and /or Poland - Sponsor

Employer
Syneos Health
Location
Client-Based, Serbia
Salary
Competitive
Start date
25 Sep 2021
Closing date
15 Oct 2021

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Job Details

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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.

This is a sponsor-dedicated role working embedded with one of our well respected Pharmaceutical clients in Serbia.

Job responsibilities
  • Mentoring of junior staff
  • Coordinate, gather, prepare and distribute the documents contained in clinical trial packages (initial submissions and Substantial amendments) to obtain HA and EC approvals for all countries (except US) in compliance with the Country Regulatory Requirements, EU Directive 2001/20/EC, related Guidance, and internal processes
  • Determine the appropriate submission strategy and consistency of the CTA packages across projects, studies and countries.
  • Effectively Lead Clinical Trial Application Tracking Meetings for the preparation of the CTA packages during start-up with cross-functional team and assure timelines and dossier quality are managed according to expectations.
  • Liaise with local and central teams and CRO as required to ensure that study start up activities are in compliance with study timelines and local regulations
  • Comply with the use and maintenance of the available planning & tracking tools to generate reports and track the CTAp content and associated dates.
  • Contribute to the Country Requirements Repository by collecting and sharing additional country requirements.
  • Ensure Compliance with any revised Guidance & Regulations at EU and Country levels.
What we're looking for
  • Bachelor's Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field
  • A minimum of 3-4 years of clinical experience
  • Experience as a Mentor
  • Ability to be Line Manager in the future
  • Good clinical research experience and knowledge of ICH-GCP
  • Experience in the preparation of the Regulatory packages for Clinical Trial Applications across multiple countries.
  • Knowledge of current regional guidelines and regulations, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in specific regions.
  • Team player
  • Strong communication, project management and interpersonal skills
  • Excellent attention to detail
  • Analytical thinking


Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health

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