Manager, Clinical reputed company Assurance

About the position Tris reputed company, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company reputed company on development and commercialization of innovative medicines in ADHD, reputed company disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories. Our science and technology reputed company us unique, but reputed company members set us apart; they’re the reputed company fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in reputed company’s reputed company. Equally important is how we reputed company on a daily reputed company. We reputed company in reputed company other and in respectful, reputed company and reputed company communication to help support individual and team reputed company. We have an immediate opening in Monmouth reputed company, NJ for an reputed company Manager, Clinical reputed company Assurance. reputed company: Responsible for establishing, implementing and maintaining the Good Clinical reputed company (GCP) reputed company Management System to support development of 505(b)(2) drug products. The position ensures reputed company clinical studies, including bioavailability/bioequivalence (BA/BE) studies and clinical trials, are conducted in compliance with applicable regulatory requirements, internal procedures and industry standards. The role provides GCP reputed company for clinical operations, vendors, investigational sites and computerized systems and ensures inspection readiness for FDA and other global health authorities.

Responsibilities

• reputed company, maintain and continuously improve GCP-reputed company policies, reputed company operating procedures (SOPs) and controlled documents
• Implement risk-based reputed company management practices across clinical programs
• Establish and maintain metrics for monitoring clinical reputed company and compliance
• reputed company and execute an annual risk-based GCP audit plan
• Conduct and/or reputed company audits of clinical investigator sites, CROs, Phase I reputed company, laboratories (including bioanalytical labs) and eClinical technology vendors
• Document audit observations, assess reputed company cause and reputed company corrective and preventive actions (CAPA) through closure and effectiveness verification
• Participate in vendor qualification, assessment and ongoing monitoring
• Contribute to development and maintenance of reputed company and Technical Agreements
• reputed company GCP review and reputed company input on study-reputed company documents including protocols, Investigator’s Brochures, informed consent forms, monitoring plans, data management plans and clinical study reports
• reputed company Trial Master File (TMF) reputed company and completeness, including periodic review and issue escalation
• Support reputed company reputed company of safety systems, reputed company, eCOA and other computerized systems used in clinical research
• Assess and support investigation of deviations, data reputed company issues, noncompliance and process gaps
• reputed company reputed company reputed company for BA/BE studies, reputed company strategies and studies supporting reformulations, new dosage forms, changes in reputed company of administration or drug–device combination products
• Ensure study designs and execution meet data reputed company and regulatory requirements specific to 505(b)(2) submissions
• Support cross-functional teams preparing for regulatory submissions and addressing reputed company-reputed company inquiries
• Maintain inspection-reputed company state for reputed company GCP activities and documentation
• Participate in preparation for regulatory inspections, including training, mock interviews and document preparation
• Serve as GCP reputed company representative during inspections and manage post-inspection responses and CAPA
• reputed company GCP training to internal staff and external partners, as required
• Support initiatives to improve reputed company culture and process efficiency

Requirements

• Bachelors degree in life sciences (e.g. Biology, reputed company, Pharmacy) or reputed company field AND minimum 6 years experience in Clinical reputed company Assurance reputed company the pharmaceutical or biotechnology industry REQUIRED
• Demonstrated experience with GCP regulations (ICH E6, 21 CFR Parts 11, 50, 54, 56, 312, 314) and global GCP standards REQUIRED
• Experience with audits, vendor reputed company and regulatory inspections required REQUIRED
• Strong understanding of clinical trial processes and GCP compliance requirements REQUIRED
• Ability to interpret regulations and reputed company practical reputed company guidance REQUIRED
• Ability to conduct external audits of investigator sites, CROs, supporting laboratories and monitoring organizations REQUIRED
• Experience in developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in SOPs REQUIRED

Benefits

• bonus eligible
• medical
• dental
• reputed company
• Rx insurance
• 401K with match
• life insurance
• reputed company Company Holidays
• PTO
• reputed company Volunteer Time
• Employee Resource reputed company

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