Senior Associate, Aggregate Report Compliance

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

New York, United States of America

Job Description:

We are searching for the best talent for Senior Associate, Aggregate Report Compliance to join our Medical Safety Quality (MSQ) organization located in New York City, NY.

A pre-identified candidate for consideration has been identified. However, all applications will be considered.

In conjunction with the Manager of Aggregate Report Compliance & Vendor Oversight, the Sr. Associate, Aggregate Report Compliance will support the oversight of the aggregate report tracking process and compliance monitoring of aggregate report submissions to Health Authorities.

In support of aggregate report compliance, the individual will be responsible for supervising compliance and ensuring appropriate documentation is completed when there are late submissions to Health Authorities.

Key Responsibilities

• Generate compliance metrics and reports in support of MSQ key partners, including:
  • Office of the Chief Medical Officer (OCMO) Senior Leadership Team
  • Office of the QPPV
  • Global Regulatory Affairs
  • International Pharmacovigilance Leadership
  • Other partners across Johnson & Johnson Innovative Medicine
• Drive the precision and consistency of compliance metrics
• Be responsible for ensuring that publication of all standard compliance metrics are completed in a timely, accurate and consistent fashion
• Innovate by streamlining processes and driving efficiencies

Qualifications

• A minimum of a Bachelor’s Degree in relevant discipline is required (Business, Science, Medical, Operations, etc.)
• A minimum of 4 years of pharmaceutical industry experience or advanced academic degree with 2 years of pharmaceutical industry experience
• A minimum of 2 years of experience in pharmacovigilance case processing, aggregate reporting, and/or PV compliance monitoring
• Knowledge of GxP requirements and experience with safety processing, clinical safety study reporting, PV and medical information preferred
• Ability to function in a global matrix environment
• Ability to develop partnerships with Global Regulatory Affairs, Local Operating Companies, and strategic vendor colleagues
• Excellent communication and writing skills
• Understanding of and experience with multi-cultural working is preferred
• Project Management experience with organizing actions and managing team activities is preferred
• Proficiency in Microsoft Excel and SharePoint is required
• Requires problem-solving skills to interpret and analyze data and information
• Experience in high volume work environment preferred.
   

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.  

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would l