Job Overview :
Submission Specialist - sponsor-dedicated
Location : Vienna, Austria
Covance has supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.
If you are looking to broaden your therapeutic expertise and sharpen your leadership skills, whilst having a true impact on the lives and health of people, 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 would love to hear from you!
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 Institutional 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
Education / Qualifications :
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