Operations Related Research Activities Specialist

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•$94,000 - $151,800

About The Position

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 compliance oversight process for market research, patient support programs and non-interventional studies. This includes fulfilling audit/inspection requests, gathering 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.

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 thinks 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.

Nice To Haves

Audit Management
Business Savvy
Coaching
Communication
Compliance Management
Continuous Improvement
Fact-Based Decision Making
ISO 9001
Issue Escalation
Problem Solving
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Regulatory Environment
Standard Operating Procedure (SOP)

Responsibilities

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.

Benefits

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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year