Johnson & Johnson seeks a Distribution Configuration Management (DCM) Analyst to manage Distribution Anchors (DAs) in the Global Safety System across multiple international sites.
Essential Job Duties and Responsibilities
- Execute daily operational activities for the setup and maintenance of DAs.
- Collaborate with internal and external partners to support DA maintenance for regulatory reporting.
- Write and update procedural documents and contribute to continuous process improvement.
- Train and mentor other DCM staff.
- Lead interactions with Local Safety Officers to gather regulatory intelligence.
- Document local country regulatory requirements and translate them into technical requirement specifications.
- Create Distribution Anchors directly in the Global Safety System.
- Manage daily workload and ensure timely completion of distribution rule tasks.
- Conduct quality control and informal testing of new or modified DAs.
- Maintain liaison with the DCM team regarding workload management.
- Deputize for Manager/Director as needed.
- Participate in team meetings and resolve processing issues.
- Drive continuous improvement of processes to meet internal and regulatory standards.
- Develop metrics to monitor key performance indicators across DCM areas.
- Assist Manager with process implementation and issue management.
Operational Activities
- Identify and resolve issues; prepare documentation and options for solutions when escalation is required.
- Perform impact assessments and manage bolus activities related to DAs.
- Provide clarification of procedures and ensure compliance when collaborating with business partners and regulatory authorities.
- Support Service Level Agreements between GMSO and Marketing Authorization Holders or Pharmacovigilance Agreements.
- Oversee DAs within the Global Safety system.
- Liaise with functional areas to resolve queries and issues.
Projects and Initiatives
- Act as Subject Matter Expert for regulatory reporting intelligence, quality monitoring, process/system improvement, compliance and quality metrics, controlled document creation, quality investigations, and CAPA activities.
- Identify and develop solutions for improvement areas, including technology automation.
Quality and Compliance
- Develop and update standard operating procedures and controlled documents for task coordination, business continuity, and audit readiness.
- Represent DCM in audits and inspections when requested.
- Investigate, document, and track compliance data and identify trends.
- Maintain knowledge of regulatory guidance for ICSR processing.
Minimum Qualification Education
Degree and/or relevant work experience; advanced degree preferred.
Required Experience
- Understanding of U.S. and EU electronic regulatory reporting requirements for ICSR.
- Experience in pharmacovigilance operations including single-case processing, database queries, and expedited reporting.
- Knowledge of regional and global safety regulations.
- Understanding of technologies, systems, and databases related to E2B electronic reporting.
- High reliability, compliance with legal and company guidelines.
- Strong organizational and communication skills, including presentation abilities.
- Ability to produce high-quality work under time-critical and high-pressure situations.
- Project Management skills desirable.
Preferred Skills
- Experience with automation of process steps.
- Knowledge of EMA, FDA, and other regulatory authorities.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin or any other status protected by law.