Responsible for reviewing and verifying executed batch records, analytical data, and quality control results to ensure compliant product release. The role involves managing documentation in eQMS, communicating with CMOs, and implementing QA standard operating procedures.
Celcuity Inc.
6 Remote Job Openings at Celcuity Inc.
Associate Director, Drug Safety and Pharmacovigilance
Celcuity Inc.
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Full Time
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2 months ago
Celcuity Inc.
Provide strategic and operational leadership for clinical safety activities, including oversight of end-to-end safety operations and external vendors. Lead the authorship of aggregate safety reports and ensure compliant safety oversight across clinical trials.
Responsible for medical oversight of drug safety and pharmacovigilance activities, including medical triage, signal detection, and risk management for marketed and developmental products. The role involves managing safety vendors, ensuring regulatory compliance, and preparing aggregate safety reports and agency queries.
The Director, MSL will be responsible for scientific exchange with healthcare providers and key decision-makers regarding Celcuity’s products and relevant disease states. They will also assist in identifying clinical trial sites and provide scientific training to internal colleagues.
Director, Medical Science Liaison, North Central
Celcuity Inc.
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Full Time
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5 months ago
Celcuity Inc.
The Director, MSL will be responsible for scientific exchange with healthcare providers and key decision-makers regarding Celcuity’s products and relevant disease states. They will also assist in identifying clinical trial sites and provide scientific training to internal colleagues.
The Senior Medical Director will provide medical oversight for clinical studies and ensure compliance with regulatory standards. Responsibilities include designing clinical study protocols, monitoring ongoing trials, and providing clinical input for regulatory documents.
