Specialist I, HGR Management (FSP）

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we&#39;re committed to making a difference.</p><p></p><p></p><p><span><b>Accountabilities*</b> </span></p><ul><li><p><span>Support CTM with the preparation of HGR submission dossier </span></p></li></ul><ul><li><p><span>Prepare and complete HGR application forms in internal and regulatory authority systems in compliance with BI SOPs, ensuring high quality and regulatory standards </span></p></li></ul><ul><li><p><span>Support communication with HGR regulatory authorities on inquiries and consultations, and assist in identifying appropriate resolutions </span></p></li></ul><ul><li><p><span>Support conducting quality review on all HGR submissions according to HGRAC regulations </span></p></li></ul><ul><li><p><span>Regular update for HGR related information </span></p></li></ul><ul><li><p><span>Tracker management, documentations archiving </span></p></li></ul><ul><li><p><span>Perform other tasks, as assigned or requested </span></p></li></ul><p><span> </span></p><p><span><b>Minimum Education/Degree Requirements*</b> </span></p><p><span>Bachelor Degree in Life Sciences, preferably in Medicine, Pharmacy or Health Sciences. </span></p><p><span> </span></p><p><span><b>Required Capabilities (Skills, Experience, Competencies) *</b> </span></p><ul><li><p><span>Minimum 1&#43; years working experience in pharmaceutical industry, ideally with HGR related experience </span></p></li></ul><ul><li><p><span>Good understanding of HGR regulations </span></p></li></ul><ul><li><p><span>Good understanding of ICH GCP, and related working knowledge and processes in clinical trials </span></p></li></ul><ul><li><p><span>Good time management skills, detail oriented, and ability to manage multiple tasks in a high-volume environment with shifting priorities </span></p></li></ul><ul><li><p><span>Good communication skills </span></p></li></ul><ul><li><p><span>Quick learner, good team player </span></p></li></ul><ul><li><p><span>Fluent in reading, writing and speaking English </span></p></li></ul>