About this role
<p style="text-align:center"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"> Join the professional team of the Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region!</span></span></p> <p style="text-align:center"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Gedeon Richter is looking for a committed and experienced professional for the position</span></span></p> <p style="text-align:center"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><strong><strong>TMF Record Specialist</strong></strong></span></span></p> <p style="text-align:center"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">on a fixed-term basis.</span></span></p><div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:14.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Responsibilities </b></H2> </div><div><ul> <li>Maintain TMF documentation in accordance with ICH-GCP, regulatory requirements, and internal SOPs</li> <li>Perform quality control (QC) checks and TMF reviews to ensure completeness and accuracy</li> <li style="list-style-type:disc"><span>Collaborate with clinical research associates, project managers, and other team members to collect and reconcile documentation</span></li> <li>Assist in TMF metrics reporting and contribute to continuous improvement initiatives</li> <li>Archival of the TMF for clinical trials</li> <li>May contribute to non-trial projects as assigned</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:14.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Requirements</b></H2> </div><div><ul> <li>Bachelor’s degree in Life Sciences, Health Sciences, or related field</li> <li>Minimum 2 years of experience in TMF management within the pharmaceutical or CRO industry</li> <li>Strong understanding of ICH-GCP and TMF reference models</li> <li>Experience with electronic TMF systems (eTMF)</li> <li>Excellent organizational skills and attention to detail</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:14.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>What we offer</b></H2> </div><div><ul type="disc"> <li>Great opportunity for professional development in an innovation driven department</li> <li>Great reputation at a well established pharmaceutical firm</li> <li>Stability and a trustworthy workplace</li> <li>Extensive benefits Package (Cafeteria)</li> <li>Various sport and health opportunities</li> <li>Excellent work life balance</li> </ul></div></div></div><p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">The Richter community is looking forward to your application.</span></span></p>