Distribution Configuration Management Analyst

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Essential Job Duties and Responsibilities:

• Responsible for completing day to day operational activities in relation to the set up and maintenance of Distribution Anchors (DAs) in the Global Safety System.
• Participate in collaborations with internal and external business partners to support the maintenance of the DAs to meet Regulatory reporting requirements.
• Help to write and update procedural documents, be involved in continuous process improvement, metrics collection and training/mentoring of other staff in DCM.
• Perform Distribution Anchor (DA) related activities.
• Lead interactions with Local Safety Officers to gather regulatory intelligence to support Distribution rule implementation and maintenance.
• Document local country regulatory requirements and interpret requirements into Distribution Anchors technical requirements.
• Create Distribution Anchors directly into the Global Safety system.
• Manage daily workload and ensure Distribution rule related tasks are completed timely as allocated to ensure completion of daily activities.
• Perform Quality Control activities of individual and team related work.
• Perform informal Testing of new/modified Distribution Anchors as required.
• Close liaison with Distribution Configuration Management team regarding workload management.
• Deputise for Manager/Director as identified.
• Contribute in team meetings and perform daily liaison with team members to identify and resolve processing issues.
• Drive the creation and continuous improvement of consistent processes that meet both internal and regulatory standards to ensure global compliance.
• Develop Metrics to monitor key performance indicators across key Distribution Configuration Management areas.
• Assist Manager with implementation of processes, and issue management.

Operational Activities:

• Identify and resolve issues or prepare documentation and options for solution where escalation is required.
• Responsible for impact assessments and bolus management activities relating to DAs.

Liaison with stakeholders and 3rd parties:

• Provide support to clarify procedures (e.g., training) to ensure compliance relating to collaboration with business partners, European Medicines Agency (EMA), Food and Drug Administration (FDA) and other Global Regulatory Authorities (RAs), Local Safety Officers (LSOs), Pharmacovigilance (PV) nominated persons, and other groups such as Global Clinical Operations (GCO), licensing partners and Regulatory Affairs (RA).
• Assist with Service Level Agreements (SLAs) between GMSO and Marketing Authorization Holders (MAHs), and/or Pharmacovigilance Agreements (PVAs).
• Liaise with other functional areas to facilitate resolution of queries and issues.

Projects and Initiatives:

• Act as Subject Matter Expert (SME) when requested in one or more of the below activities:
• Regulatory Reporting intelligence
• Quality monitoring activities
• Process/system improvement
• Compliance and quality metrics preparation
• Controlled document creation/update
• Quality Investigations and CAPA activities
• Identify and develop solutions for areas needing improvement and consider the use of technology for the automation of process steps.

Quality and Compliance:

• Develop/update Standard Operating Procedures (SOPs) and other controlled documents relevant for the coordination of tasks, business continuity and audit/inspection readiness.
• Represent Distribution Configuration Management in audits and inspections when requested and provide support for document requests.
• Investigate, document and track compliance related data and identify any trends.

Other:

• Maintain knowledge on worldwide regulations/guidance related to Individual Case Safety Report (ICSR) case processing and reporting activities.

Minimum Qualification:

• Degree and/or relevant work experience, advanced degree is preferred.

Required Experience:

• Developed Understanding of US and EU electronic regulatory reporting requirements for ICSRs.
• Accumulated expertise in pharmacovigilance operations related activities including single case processing, database queries, expedited reporting.
• Knowledge of regional and global safety regulations.
• Good understanding of technologies, systems and databases related to E2B electronic reporting.
• Highly reliable, and compliant with legal and company guidelines.
• Excellent organizational and communication skills including presentation abilities.
• Ability to produce high quality work under time critical and high-pressure situations.
• Project Management Skills desirable.