Operations Related Research Activities Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for an Operations Related Research Activities (RRA) Specialist to be based in Titusville, NJ; Raritan, NJ; or Horsham, PA.

Purpose: Responsible to execute the pharmacovigilance compliance oversight process for market research, patient support programs and non-interventional studies. This includes fulfilling audit/inspection requests, gathering and/or generating key performance and compliance metrics and addressing issues as appropriate to ensure compliance.

You will be responsible for:

• Data Analysis and Visualization: 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. This includes ensuring that required documentation is up-to-date and readily available for audits and inspections.
• 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. This may include development of oversight reports.
• 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.

Qualifications/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 systemati