Submission Specialist - sponsor-dedicated

Vienna, Austria
10 Jun 2021
12 Jun 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Submission Specialist - sponsor-dedicated

Location: Vienna, Austria / Home Office, Austria

Covance by Labcorp has supported the pharmaceutical industry worldwide in developing more medicines than any other company, including the top 50 best-selling drugs on the market today. If you are looking to deepen your functional expertise in the start-up phase of clinical studies, while leveraging your organizational and communication talent, this is the perfect opportunity. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

We are looking for Submission Specialists to work directly with one of our renowned key sponsors, advancing the development of innovative, life-changing medications.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

Sounds exciting? Then we look forward to meeting you soon!

As Submission Specialist, your will:
  • Act as the primary contact for your assigned investigative site(s) during site start-up activities and site maintenance
  • Collaborate closely with internal and external stakeholders, e.g. Project Management, Global Regulatory Services, Study Start-Up teams and regulatory authorities
  • Collect required investigator and essential documents for a study
  • Prepare high quality submissions to Ethical Committees (EC) and I nstitutional Review Boards (IRB) and any other Austrian regulatory authorities
  • Ensure all documents and submissions meet the required specifications and are filed according to agreed timelines
  • Ensure that all assigned start-up and maintenance activities are on track and in accordance with our sponsor's expectations, ICH / GCP, SOPs, budget, and the applicable laws
  • Liaise with Institutional Review Boards, Ethical Committees and other applicable regulatory authorities to resolve any issues with submissions and/or approvals where necessary
  • Continuously and diligently update all systems to ensure we are always prepared to be audited
  • Serve as our local expert for study start-up activities in Austria
  • Mentor, coach and train new hires and colleagues
  • Degree in a relevant field such as life sciences, pharmacology, (veterinary) medicine, oecotrophology etc., alternatively an equivalent scientific or commercial Higher Vocational education or relevant professional experience
  • Professional experience in clinical development and / or clinical research - preferably at a CRO or a pharmaceutical company -, including a solid understanding of Austrian regulatory processes
  • Proven experience with investigator start-up documents and regulatory submissions in Austria - observing all local regulations and guidelines as well as ICH / GCP
  • Experience negotiating contracts and managing budgets is a plus
  • Autonomous work style with a keen eye for detail and a high sense of accountability
  • Ability to build trustful, sustainable relationships with a wide variety of stakeholders based on your outstanding listening and communication skills
  • Business fluency in German and English - both spoken and written - is a must