Johnson & Johnson

Operations Research Specialist

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Titusville • New Jersey • Pennsylvania • United States

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Salary

💰 $94,000 - $151,800 per year

About the role

  • Responsible to execute the pharmacovigilance compliance oversight process for market research, patient support programs and non-interventional studies.
  • Serve as the primary monitor of RRA metrics and KPIs, collaborate with stakeholders to create and monitor meaningful digital dashboards that enable clear interpretation and data-driven decision making.
  • Review and approve Market Research, Patient Support Programs, and/or non-interventional studies program within defined system per documented procedures.
  • Make decisions in a timely manner to prevent noncompliance or to address compliance issues.
  • Maintain and compile proper documentation of compliance activities.
  • Ensure accurate data within the system to generate key performance and compliance metrics.
  • Review compliance reports and other relevant data to inform decision-making on actions that need to be taken to prevent noncompliance and/or resolve issues.
  • Assist in identifying potential compliance risks within the organization and work with management to develop strategies and controls to mitigate those risks.
  • Perform reconciliation of safety data against the safety database.
  • Liaise with Global Medical Safety Organization and suppliers as needed to ensure all safety data was received and documentation meets Company policy requirements.
  • Support noncompliance process that may include initiating quality investigations and managing the record to ensure effective correction is in place.
  • If required, manage 3rd party vendor performing manual compliance tasks to ensure accuracy.
  • Collaborate with key functional partners such as Commercial Activity Owners, Local Medical Safety, and R&D Activity Owners to ensure compliance requirements are met.
  • Fulfill inspection and audit requests and/or provide subject matter expertise of the compliance oversight process for Market Research, Patient Support Program, and non-interventional activities.
  • Support the implementation of process efficiencies and continuous improvements to decrease cycle time and improve quality of data.
  • Collaborate with relevant stakeholders to assess compliance needs, develop procedures, and provide training and guidance.
  • Assist in the development, implementation, and maintenance of compliance policies, procedures, and guidelines associated with market research, patient support programs and non-interventional studies.
  • Educate Activity Owners on regulations and policies, providing guidance on compliance-related issues, and raising awareness about potential risks and consequences of non-compliance.
  • Perform related duties as assigned by supervisor. Maintain compliance with all company policies and procedures.

Requirements

  • Minimally a Bachelor’s degree in Science, Engineering and Technical subjects.
  • Minimum of 2 years of pharma or clinical experience.
  • Understanding of relevant regulations, laws, and industry standards.
  • Familiar with the compliance requirements and be able to interpret and apply them effectively.
  • Ability to manage issues using deductive reasoning, critical analysis skills and systematic approaches.
  • Able to analyze data, identify potential compliance risks or noncompliance, and make recommendations based on their findings.
  • Ability to think in a clear, decisive manner, remains calm under adverse conditions, and reaches independent, reasoned decisions and solutions when required.
  • Organizational and time management skills to prioritize tasks, meet deadlines, and ensure that compliance activities are carried out effectively.
  • Able to build positive relationships, demonstrate effective collaboration, and work as part of a team.
  • Strong influence and negotiation skills.
  • Critical thinking and leadership skills.
  • Able to interact with Regulatory Authorities.
  • Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
  • Excellent computer proficiency e.g MS Office, SAP.
  • Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
  • Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Benefits
  • 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)).
  • 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 period
  • 10 days Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
pharmacovigilancedata analysiscompliance oversightrisk managementsafety data reconciliationmarket researchpatient support programsnon-interventional studiesregulatory compliancequality investigations
Soft Skills
critical thinkingproblem-solvingorganizational skillstime managementcollaborationinfluence skillsnegotiation skillscommunication skillsdeductive reasoningleadership skills