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About the role
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<p><span style="font-size: 12pt;"><strong>About Clinchoice<br><br></strong>ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.</span><br><br><span style="font-size: 12pt;">Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.</span><br><br><span style="font-size: 12pt;">We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.</span><br><br><strong><span style="font-size: 12pt;">Job Description</span><br><br></strong><strong>Primary Responsibilities:</strong></p>
<p><span style="font-size: 12pt;">• Responsible for the coordination and compilation of the relevant data to complete a PSUR. </span></p>
<p><span style="font-size: 12pt;">• Ensures open communication with the stakeholders (Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, etc.) through the PSUR writing process to ensure adherence to published schedules. </span></p>
<p><span style="font-size: 12pt;">• Communicate concerns/delays with data collection and/or reviews within the PSUR Manager Medical Operations to ensure on time completion of the PSUR reports. </span></p>
<p><span style="font-size: 12pt;">• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.</span></p>
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