Principal Consultant - GCP / BIMO Compliance

Parexel’s Regulatory Consulting team is known for our unparalleled breadth and depth of expertise globally. Parexel Consulting offers services which create and maximize product value for clients throughout the product life cycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world, and we are growing!

We currently have home-based openings on our Regulatory Compliance & Risk Management Team for highly experienced BIMO/ GCP Compliance Investigators/Consumer Safety Officers to join the Parexel Regulatory Consulting team as Principal Consultants.

A Principal Consultant will have the knowledge and ability to provide clients with recommendations on how to bring their processes and procedures into compliance with cGMPs and industry best practices; the ability to write clear, concise, objective reports and recommendations; and effectively communicate and interact with our clients at all levels within their organization.

A Principal Consultant must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. A Principal Consultant provides a full range of consulting services and works within their personal area of expertise. A Principal Consultant provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within PC.

We are currently seeking experts with past experience helping pharmaceutical, biopharmaceutical, and medical device companies manage and prepare for FDA inspections and to manage post inspection activities.

To include specialized experience in the following:

• Sponsor-Monitor Audits (Drug, Device, Biologic)

• Clinical Investigator Audits (Drug, Device, Biologic)

• CRO Audits (Drug, Device, Biologics)

• Drug GMP and Medical device QSR Audits

• Data Integrity Assessments

• Assist in the preparation of written responses and remediation plans to address FDA-483 Inspectional Observations and Warning Letters

•On-Site guidance during FDA inspections

•Review of study protocols and recordkeeping documents for clinical site use

•Preparation for Discussion of Regulatory Compliance Matters with FDA

QualificationsMinimum of a Bachelor’s Degree in a Scientific or Technical Discipline

Previous experience as a Consumer Safety Officer, BIMO and/or Compliance Investigator, or similar role to include numerous years’ experience planning and conducting complex regulatory inspections and in-depth investigations coupled with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA) are required.

Domestic and International Travel Required EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.