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.
Required Skills:Preferred Skills:Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
The anticipated base pay range for this position is :$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
