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 Job #03122 Email this job to a friend
About our client
Our client is the world's leading bio/pharmaceutical services organization. They have developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Headquartered near Boston, Massachusetts, our client has offices in over 40 countries around the globe.
Position Location
Senior Auditor (1) and Auditor (2) Boston, Massachusetts
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Foster a good working relationship with internal and external clients
2) Oversee promotion of compliance within the company
3) Plan and conduct audits, including complex assignments and deliver a written report
4) Provide input (proactively) to management on audit plans/strategy
5) Recognize areas (proactively) for process/procedural improvements, providing input to management and taking the initiative (as appropriate)
6) Maintain working knowledge of project /audit status
7) Mentor and assist with training of less experienced auditors
8) Maintain and/or develop records/documents related to assigned areas
9) Facilitate sponsor audits/regulatory inspections (as assigned)
10) Exhibit a high degree of flexibility and initiative
11) Provide direction and coordination for project in liaison with RRC management and staff
12) Provide advice on regulatory compliance
13) Perform other duties as assigned
Requirements
1) Bachelor’s degree
2) Minimum 3 years of experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GCP auditing
3) Working knowledge of and expertise in policies, procedures and guidelines, as well as applicable national and international regulations and requirements and ability to apply them (as needed)
4) Ability to maintain a big picture/overview on the project/business
5) Ability to follow up on multiple tasks and projects
6) Ability to review and identify improvements that enhance the quality and clarity of audit reports (as needed)
7) Ability to handle confidential information diplomatically
8) Detail oriented
9) Willingness to travel on assignment

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