Distribution Config Mgt Sr 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. Learn more at https://www.jnj.com

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Essential Job Duties and Responsibilities

Responsible for execution and oversight of operational activities within the

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Distribution Config Mgt, Senior Analyst to be in High Wycombe, United Kingdom.

Please note that our office will be relocating to central Maidenhead from October 2026. Applicants should ensure that this location is suitable for them.

Distribution Configuration Management (DCM) team, including management of Distribution Anchor (DA)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 and 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 include:

• Provide supervision and oversight for day to day and end to end activities of the Distribution Configuration Management (DCM) Team
• Performs Distribution Anchor related activities.
• Leads interactions with Local Safety Officers to gather regulatory requirements to support Distribution Anchor configuration and maintenance.
• Documents local country regulatory requirements and interprets requirements into Distribution Anchor technical requirements.
• Creates Distribution Anchors directly into the Global Safety system.
• Performs Quality Control activities of individual and team related work.
• Performs User Acceptance Testing of new/modified Distribution Anchors as required.
• Deputizes for Manager/Director as identified.
• Workload oversight and Team Leadership
• Manages the daily workload and ensures tasks are allocated as required.
• Takes the lead in team meetings and daily liaison with team members to identify and resolve issues.
• Prepares agendas, facilitates team meetings, and takes minutes.
• Flags resourcing or operations concerns to manager/director in timely manner.
• Takes the lead and drives the creation and continuous improvement of consistent processes that meet both internal and regulatory standards to ensure global compliance.
• Assists Manager/Director with implementation of processes, and issue management.
• Liaises with technical vendors supporting the Global Safety System 

Operational Activities

• Leads/Supports Quality investigation related to Distribution Anchors
• Identifies and resolves issues or prepares documentation and options for solution where escalation is required.
• Supports impact assessments and bolus management activities as needed.
• Supports Metrics collection and analysis as needed.
• Provides support for holiday cover according to the Business continuity plan.
• Prepares training material and delivers training.
• On the job training and mentoring of staff as required
• Acts as Subject Matter (SME) expert in one or more of the below 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: awareness of and input to company procedures and guidance

• 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.
• Promotion of awareness of procedural document requirements within team, including contract and relevant vendor personnel

Project work: participation in assigned projects, including inspection/audit readiness activities.

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

Mentoring & supervision:

Mentoring of Distribution Rule Management Team (or other identified) staff, and involvement in recruitment and supervision.

Process and Distribution Anchor experts:

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.

Perform other related duties as required.

• Maintains compliance with company guidelines and HR policies.

Minimum Qualification

• 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 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
• 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

Required Skills:

Preferred Skills: