JRAD

Process Advisor

Job Title:

Process Advisor

Job Description
Location: Multiple customer support locations exist for this position. Address position specific support locations with JRAD’s Hiring Manager.
Position Type: Full-Time
Level: Seeking candidates at all levels from entry level to senior positions requiring advanced degrees and experience.
Travel Required: Travel may be required to support customer mission requirements but is not anticipated to exceed 25%.

 
Role and Responsibilities:

  • Provide scientific and technical support during the development or transfer of new biologics and other medical technologies.
  • Assist in determining strategic direction of the project office by proposing and implementing actionable strategies to address critical issues.
  • Review pertinent correspondence and related documents for scientific and medical content, and evaluate all aspects of the clinical study protocol.
  • Provide insight on current good laboratory and manufacturing processes and FDA requirements.
  • Advise the client on the impact of changing trends in the pharmaceutical industry and FDA policies and requirements, and recommend courses of action.
  • Provide advice on the impact of legislative changes and directives from higher echelons and recommend courses of action, as well as ensure application of pertinent inter-state and foreign commerce laws and regulations governing manufacturing and shipment.
  • Shall facilitate communication and coordination with the FDA, as required.
  • Additional duties commensurate with position roles and responsibilities may be required by specific customers.

Minimum Required Skills and Education:

  • Bachelor’s Degree or equivalent experience.
  • Two (2) years of relevant experience.

Security Clearance:

  • Must be able to obtain and maintain a DoD clearance.

 
JRAD is an Equal Opportunity Employer Veterans/Disabled

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