Johnson & Johnson Innovative Medicine · 14 hours ago
Operations Related Research Activities Specialist
Titusville, NJ
Full-time
Onsite
Entry, Mid Level
$94K/yr - $152K/yr
2+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to building a world where complex diseases are addressed effectively. They are seeking an Operations Related Research Activities Specialist responsible for executing compliance oversight processes for market research and patient support programs, ensuring adherence to regulations and effective data management.
Pharmaceuticals
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. 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
Qualification
Required
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
Preferred
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)
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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