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Submission Specialist - sponsor-dedicated

Laboratory Corporation of America Holdings (Covance)

Vienna, Austria

<h2>Job Overview:</h2><p style="margin-bottom: 3.0pt;"><span style="text-decoration: underline;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Submission Specialist - sponsor-dedicated</span></span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Location: Vienna, Austria / Home Office, Austria</span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0cm 1.7pt 3.0pt 0cm;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="color: windowtext;">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. </span><span style="color: windowtext;">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. </span><span style="color: windowtext;">Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers. </span></span></p><p style="margin: 0cm 1.7pt 3.0pt 0cm;"><span style="font-size: 10pt; color: windowtext; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">We are looking for Submission Specialists to work directly with one of our renowned key sponsors, advancing the development of innovative, life-changing medications. </span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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.</span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Sounds exciting? Then we look forward to meeting you soon!</span></p><p style="margin-bottom: 3.0pt;"> </p><p style="margin-bottom: 3.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><u>As Submission Specialist, your will:</u></span></p><ul><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Act as the primary contact for your assigned investigative site(s) during site start-up activities and site maintenance</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Collaborate closely with internal and external stakeholders, e.g. Project Management, Global Regulatory Services, Study Start-Up teams and regulatory authorities</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Collect required investigator and essential documents for a study</span></li><li style="margin-bottom: 3.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="color: black;">Prepare high quality submissions to Ethical Committees (EC) and I</span><span style="color: #222222;">nstitutional Review Boards (IRB) </span><span style="color: black;">and any other Austrian regulatory authorities</span></span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Ensure all documents and submissions meet the required specifications and are filed according to agreed timelines </span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">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</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Liaise with Institutional Review Boards, Ethical Committees and other applicable regulatory authorities to resolve any issues with submissions and/or approvals where necessary</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Continuously and diligently update all systems to ensure we are always prepared to be audited</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Serve as our local expert for study start-up activities in Austria</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Mentor, coach and train new hires and colleagues</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-bottom: 3.0pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">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</span></li></ul><h2>Experience:</h2><ul><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Proven experience with investigator start-up documents and regulatory submissions in Austria - observing all local regulations and guidelines as well as ICH / GCP</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Experience negotiating contracts and managing budgets is a plus</span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Autonomous work style with a keen eye for detail and a high sense of accountability </span></li><li style="margin-bottom: 3.0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Ability to build trustful, sustainable relationships with a wide variety of stakeholders based on your outstanding listening and communication skills</span></li><li style="margin-bottom: 3.0pt;"><span style="text-decoration: underline;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Business fluency in German and English – both spoken and written – is a must</span></span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">#LI-AR1</span></p><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Remote</span></p>

Job posted: 2021-05-05

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