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Search for Jobs by David Wright

Home-based Pharmaceutical Sr. Manager, GCP Clinical Quality and Regulatory Management (Science & Biotech)
New York, NY 10017
Recruited by: David Wright | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Science & Biotech
  • Compensation: Salary: 155K to 180K
  • Expires: Jun 13, 2019
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Job Description

This is a new role for the pharmaceutical company where they are looking for a Manager who can help them to prepare for Inspection Readiness. They are filing several new products with the FDA this year and want to have someone who has had experience preparing for FDA, MHRA and other regulatory authority audits associated with filing new products. They want a Project Manager to help them to organize this but this person has to have had Quality Management experience.


Summary/Scope:

Lead program teams through the activities of preparing for worldwide health authorities inspections following marketing applications.

Skills/Knowledge Required:

• Experience in overseeing clinical trials - including vendor management (min. 7-10 years’ experience preferred)
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Familiarity with ICHE6/R2 GCP, BIMO guidance, MHRA, EMA, and major health authority guidance, checklists, and expectations for sponsors of clinical trials
• Previous experience in preparation for FDA/other regulatory authority GCP inspections
• Ability to effectively project manage activities related to inspection readiness preparation
• Ability to strategically evaluate trials and potential inspection risks/mitigations
• Effective communication and organizational skills
• Strong oral and written skills with proficiency in English
• Identifies gaps and provides constructive feedback and solutions
• Ability to multi-task effectively and prioritize assignments from multiple sources