Distribution Config Mgt Sr Analyst in High Wycombe

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.

Essential Job Duties and Responsibilities:

• Responsible for execution and oversight of operational activities within the Distribution Configuration Management (DCM) team, including management of Distribution Anchor requests (new/modification of existing), and providing support to junior members of staff as needed.
• The DCM Senior Analyst will also participate in collaborations with internal and external business partners, assist with updates to procedural documents, be involved in process improvement, metrics collection, and training/mentoring of staff in DCM.
• The DCM Senior Analyst liaises with staff in Global Medical Safety Operations (GMSO) functions (Global Case Receipt, Global Case Processing, Global Safety Reporting).

Responsibilities:

• Provide supervision and oversight for day-to-day and end-to-end activities of the Distribution Configuration Management (DCM) Team.
• Perform Distribution Anchor related activities.
• Lead interactions with Local Safety Officers to gather regulatory requirements to support Distribution Anchor configuration and maintenance.
• Document local country regulatory requirements and interpret requirements into Distribution Anchor technical requirements.
• Create Distribution Anchors directly in the Global Safety system.
• Perform quality control activities of individual and team-related work.
• Perform user acceptance testing of new/modified Distribution Anchors as required.
• Deputise for Manager/Director as identified.
• Manage the daily workload and ensure tasks are allocated as required.
• Take the lead in team meetings and daily liaison with team members to identify and resolve issues.
• Prepare agendas, facilitate team meetings, and take minutes.
• Flag resourcing or operations concerns to manager/director in a timely manner.
• Lead and drive the creation and continuous improvement of consistent processes that meet both internal and regulatory standards to ensure global compliance.
• Assist Manager/Director with implementation of processes and issue management.
• Liaise with technical vendors supporting the Global Safety System.

Operational Activities:

• Lead/Support quality investigation related to Distribution Anchors.
• Identify and resolve issues or prepare documentation and options for solution where escalation is required.
• Support impact assessments and bolus management activities as needed.
• Support metrics collection and analysis as needed.
• Provide support for holiday cover according to the business continuity plan.
• Prepare training material and deliver training.
• Provide on-the-job training and mentoring of staff as required.
• Act as subject-matter expert in one or more of the following activities: Regulatory reporting requirements, Attribute functionality and configuration impact on DAs and subsequent submission, Quality monitoring activities, Process/system improvement, Compliance and quality metrics preparation, Controlled document creation/update, Quality investigations and CAPA activities.

Processes & Procedures:

• Completion of all assigned training on company and GMSO procedural documents relating to safety submission activities.
• Completion of training relating to relevant PV Agreements.
• Participate in designated activities to support revision/creation of Distribution Rule procedural documents.
• Promote awareness of procedural document requirements within team, including contract and relevant vendor personnel.

Project Work:

• Participate in local or global project teams, including on-time delivery of assigned responsibilities.
• Participate in inspections and audits as identified, including interviews and provision of requested data.
• Assist in preparation or implementation of corrective/preventative actions related to Distribution rules.

Mentoring & Supervision:

• Mentoring of Distribution Rule Management Team (or other identified) staff, and involvement in recruitment and supervision.
• Act as key contact or point of expertise for team members and internal/external contacts (e.g. Regulatory Authorities, Business Partners, Global Case Management, Global Regulatory Affairs).

Personal Development:

• Continuous development of personal skills whether task or competency related. Activities may include project involvement, technical training, regulatory expertise, shadowing and/or mentoring others, soft-skill development.
• Maintain knowledge of department policies and procedures.
• Maintain knowledge on worldwide regulations/guidance related to single case processing activities.

Other Duties:

• Maintain compliance with company guidelines and HR policies.

Minimum Qualifications:

• Bachelor of Arts or Bachelor of Science Degree preferred or demonstrated competency and significant relevant work experience.
• Developed understanding of US and EU electronic regulatory reporting requirements for ICSR.
• 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.
• Sense of urgency (timelines).
• Strong attention to detail.
• Ability to influence various stakeholders.
• Excellent organizational and communication skills including presentation abilities.
• Ability to work in a fast‑changing environment.
• Ability to produce high quality work under time‑critical and high‑pressure situations.

Other Requirements:

• N/A