Manager of Regulatory Affairs, Quality Assurance and Technical Writing - (Piscataway, NJ)

Our client, a leading clinical research company, is looking for a Manager of Regulatory Affairs, Quality Assurance & Technical Writing to join their team. If you have the necessary background and are up for a challenge, this could be a great opportunity for you. Assignments include: 1) Review study reports, trial files and any other supportive documents for concurrence with the protocol 2) Conduct periodic audits of systems related to the conduct of clinical trials and non-clinical studies 3) Conduct in-phase study monitoring and facility audits 4) Provide organized reports of monitoring and audit findings with recommended corrective and preventive actions to the Management 5) Contribute to the development, review, maintenance and issuance of SOP 6) Meet with staff to discuss or review study folders or final reports and facility audits 7) Provide training to staff as needed and maintain staff training files 8) Participate in the development of departmental procedures as needed