Operations Related Research Activities Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 Bachelors 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

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)

The anticipated base pay range for this position is :

$94000.00 - $151800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys 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: Experience:

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