Sr. Compliance Analyst

Johnson & Johnson

Title: Sr. Compliance Analyst

Location: Raritan, NJ

Duration: 1 Year

Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits

Please note that this is a contract role providing services to Johnson & Johnson through external staffing partners of Kelly OCG. If you are selected for this role, you will be employed by a contract staffing supplier and will not be an employee of Johnson & Johnson

Summary:

Sr. Associate, Aggregate Report Compliance In conjunction with the Manager of Aggregate Report Compliance and 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. The individual will drive the precision and consistency of compliance metrics and be responsible for ensuring that publication of all standard compliance metrics are completed in a timely, accurate and consistent fashion and will innovate by streamlining processes and driving efficiencies. Keys for success in this role include the ability to develop partnerships with Global Regulatory Affairs, Local Operating Companies, and strategic vendor colleagues.

Responsibilities:

• The Sr. Associate, Aggregate Report Compliance will generate compliance metrics and reports in support of MSQ Compliance and Risk Management 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 business
• Compliance metrics and data produced feed into:
• Quality Management Reviews
• Medical Safety Council Operational Compliance Committees
• Other compliance review venues and for other functional partners
• Support the aggregate report tracking process and systems
• Monitor compliance of aggregate report submissions to Health Authorities and generation of compliance metrics
• The individual, with oversight from the Manager of Aggregate Report Compliance and Vendor Oversight, will be accountable for prioritizing and ensuring that deliverables are completed on time and are accurate and consistent.
• The individual will follow documented processes and procedures for aggregate report compliance monitoring and metrics generation.

Qualifications:

• Minimum of Bachelor’s degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 4 years of pharmaceutical industry experience or advanced academic degree with 2 years of pharmaceutical industry experience required.
• Minimum of 2 years of experience in pharmacovigilance case processing, aggregate reporting, and/or PV compliance monitoring required.
• Proficiency in Microsoft Excel and SharePoint is required
• Requires problem-solving skills to interpret and analyze data and information
• 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
• 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
• Experience in high volume work environment preferred.