Operations Related Research Activities Specialist

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Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom - Requisition Number R-063064

Egypt - Requisition Number R-064415

Malaysia and Singapore - Requisition Number R-064875

Belgium Italy and Spain - Requisition Number R-064874

J&J Innovative Medicine is recruiting for an Operations Related Research Activities Specialist reporting to the RRA Operations Manager and to be based in one of the locations where the position has been posted

Job summary

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.

Essential Job Duties and Responsibilities

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 International Pharmacovigilance (IPV) 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.

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.

Minimum Qualification

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.

Applicable just for the United Kingdom job posting:Please note that our office will be relocating to central Maidenhead from October 2026. Applicants should ensure that this location is suitable for them.

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