Contract Manager GCP Auditing position – Remote

Contract Manager GCP Auditing position – Remote 6 month contract, reputed company pay, *****W2 only, no 3rd parties*** reputed company Top East Coast reputed company is looking to hire a contractor to help build, partner and implement reputed company auditing activities. Must have solid Good Clinical reputed company (GCP), international regulations to the auditing process to independently address GCP compliance issues. Strong knowledge of the FDA and EU regulations and ICH guidance documents for drug development and post-authorization safety monitoring. Will conduct multiple audit typeslike process, vendor, site, and license partner, depending on the requirements of the GCP subject area. Daily responsibilities include: End to end audit process, scheduling, conducting, preparing, reporting and follow up on routine and directed audits in support of the GCP (Investigator Site, Service Provider and internal process) as directed and reputed company with reputed company operating procedures and reputed company policies. Conduct Internal audits and external audits globally. Represent department for reputed company compliance reputed company and initiatives both reputed company and across functional areas or other departments. Support clinical studies as a reputed company representative to reputed company and implement risk-based audit programs for assigned studies (GCP). Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered. May assist with training/orientation/mentoring of new department staff. Participate in regulatory inspections by acting as part of the control and inspection room team. Required: • BS and 5+ years of relevant industry experience and 3+ years of reputed company GCP audit experience. • Must have experience with FDA and EU regulations and ICH guidance documents. Apply tot his job Apply To this Job