Field Alert Author Coordinators [Pharma/Medical Device]

  • Contract

Company Description

CP is ranked 3rd in the NJBIZ Top 50 Companies to Work for and is listed in NJBIZ 50 Fastest Growing Companies in NJ.

CP Professional Services (CP) is a full service Life Sciences Quality and Compliance consulting firm also offering Full Service Engineering consulting services headquartered in Sparta, New Jersey with offices in Florham Park NJ and San Diego CA. CP is committed to our clients and develops innovative strategies and targeted solutions necessary to exceed standards and our clients' individual needs, goals and expectations.

 

Job Description

This position is responsible for timely completion and issuance of Initial, Follow-up and Final Field Alert Reports (FARs) for a leading, Life Sciences company.

This is a 6+ month consulting assignment and does not offer relocation assistance.

Role Responsibilities:

  • Participation in Complaint Triage meetings for review of the complaint events to determine FAR requirements.
  • Coordination/Generation of Initial/Follow-up/Final FARs, assuring that timing requirements are met for issuance of Initial and Follow-up FARs.
  • Communication with key site personnel for any information required to generate the FARs and address review feedback.
  • Communication with Senior Management reviewers/approvers regarding review feedback and alignment on updates required in the FARs.
  • Provide audit support with timely data preparation to address inspection requests related to Complaints, FARs and Market Actions.
  • Strong technical writing skills.
  • Solid analytical skills and attention to detail are important for this job function to ensure accuracy of the FARs and alignment of the FAR content with the investigation completed for the event.


 

    Qualifications

    • Bachelor’s Degree Required
    • Proficiency with MS Office applications (Word, Excel, PowerPoint, Visio, etc.)
    • Strong analytical and problem solving skills
    • Has strong interpersonal skills and ability to communicate with diverse groups and individuals
    • Strong technical writing skills
    • Good organizational skills 

    Additional Information

    1. All your information will be kept confidential according to EEO guidelines.
    2. Please attach WORD resume in your profile
    3. Work is on-site
    4. This is a contract assignment NOT a full-time job
    5. 1099 OR W2
    6. MUST BE LOCAL to St. Louis MO - there is no relocation assist for this consulting assignment
    7. 6+ month assignment