INTERNATIONAL CLINICAL AUDITOR - DRUG SAFETY

Position code: 4274 Position Title: INTERNATIONAL CLINICAL AUDITOR - DRUG SAFETY



Work Location: New Jersey - Nutley Corporate Headquarters



Major Responsibilities:

Applies quality assurance expertise to the auditing process. Performs and/or leads clinical trial site, safety and systems audits to facilitate the production of high-quality clinical study data. Evaluates the audit findings within a team or project, which may have a substantial impact on the company's business. Advises the Pharma Study Management Team on quality assurance issues on an ongoing basis. Reviews and advises on guidelines, policies and SOPs of Pharma and other relevant departments within Roche. Assists in the development and revision of the International Strategic Quality Assurance Plan (SQAP), PDQ policies and procedures and their implementation. Contributes to GCP training programs on an international basis. Prepares investigational sites and/or Roche departments for inspection by regulatory agencies.

Qualifications:

BS degree required in a scientific discipline, with a PharmD, Ph.D desirable, with five years experience in an international, multidisciplinary team environment or equivalent degree in a biomedical/scientific discipline with three years experience in drug development. GCP Quality Assurance experience including the area of pharmacovigilence auditing experience is desirable. Demonstrated analytical, organizational, problem-solving and decision making skills. Excellent oral and written communication skills. In addition to English fluency, a knowledge of another European and/or Asian language is desirable. International and national travel required up to 60%. Accreditation as lead quality management systems auditor by IRCA or equivalent preferred.