7360-Janssen-Cilag Limited Legal Entity

7360-Janssen-Cilag Limited Legal Entity seeks a Distribution Configuration Management (DCM) Analyst in High Wycombe to manage Distribution Anchors across multiple international sites. Responsibilities include executing daily operational tasks, collaborating on regulatory reporting, and supporting continual process improvement. The ideal candidate has relevant education, experience in pharmacovigilance, and strong organizational skills. This role also emphasizes compliance and quality control within the Global Safety system.

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.

Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Position Summary The Experienced Clinical Programmer is an experienced clinical trial programmer with in-depth knowledge in industry standard and complex data structures, programming languages, and/or reporting solutions with proven technical capabilities in leading clinical trial activities and/or teams in accordance with departmental processes and procedures. The position is responsible for oversight or the development of one or more clinical data management trial activities of moderate to high complexity/criticality. Including data model specifications, data stream integrations and transformation of source to internal data models and/or CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc). Creates and executes edit check programs, listings and report solutions to aid in monitoring of safety, risk, compliance and ensures quality data review. Performs reporting solutions role creating study-specific reports translating clinical study team needs into specifications aggregating clinical data sources into custom data and report to monitor safety, risk and compliance. Responsibilities Accountable for one or more clinical programming trial activities of moderate to high complexity, scope and/or criticality. Performs comprehensive review of, and provides input into, project requirements and documentation. Identifies gaps, proposes solutions and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Ensures latest standards are being utilized, current technologies are deployed. Create and/or review specifications for mapping internal data review model for fit for purpose reporting and/or as well as submission ready CDISC SDTM. Design mapping algorithms for nonstandard conversions. Responsible for creation or review of internal data model for fit for purpose reporting consumption and/or submission ready CDISC SDTM packages for health authority submissions and keeping abreast in changing regulatory requirements. Program, or oversight of quality review checks, study specific reports for use by team members and consumers of data. May perform role that programmatically aggregates clinical data sources into custom data model for fit for purpose consumption study specific report solutions performing appropriate quality control and verification in support of assigned reporting activities. Support and/or lead in developing and implementing process, system and tool improvement initiatives within compliance with departmental processes and procedures. Required Skills Advanced Analytics Analytical Reasoning Biological Sciences Biostatistics Clinical Trials Data Modeling Data Privacy Standards Data Quality Data Savvy Detail-Oriented Good Clinical Practice (GCP) Report Writing Research EthicsResearching Statistical Analysis Systems (SAS) Programming Statistics Technologically Savvy Preferred Skills Advanced Analytics Analytical Reasoning Biological Sciences Biostatistics Clinical Trials Data Modeling Data Privacy Standards Data Quality Data Savvy Detail-Oriented Good Clinical Practice (GCP) Report Writing Research Ethics Researching Statistical Analysis Systems (SAS) Programming Statistics Technologically Savvy

7360-Janssen-Cilag Limited Legal Entity is seeking an Experienced Statistical Programmer to support data analysis and reporting within the Statistical Programming functional area. The candidate will design and develop statistical programs, ensuring the quality and timeliness of deliverables in clinical research. Responsibilities include developing statistical programs, maintaining documentation, and collaborating with cross-functional teams. The role requires strong analytical skills, attention to detail, and experience in SAS programming. Join a dedicated team in High Wycombe and contribute to improving clinical outcomes.

7360-Janssen-Cilag Limited Legal Entity is seeking an Experienced Clinical Programmer to oversee clinical trial programming activities in High Wycombe, England. The role requires a strong background in data analytics and programming languages to ensure quality data management. The ideal candidate will be accountable for complex programming tasks, ensuring compliance with standards, and developing custom reporting solutions. Key skills include biostatistics, SAS programming, and attention to detail. This position offers a chance to work in a dynamic environment with a focus on quality and compliance.

At Johnson & Johnson, we believe health is everything and are committed to an inclusive work environment. The Experienced Statistical Programmer will support data analysis and reporting activities within the Statistical Programming functional area. This role is responsible for the development, verification, and documentation of code used for the analysis and reporting of clinical data and is accountable for the timeliness and quality of assigned deliverables. Job Details Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology Location: High Wycombe, Buckinghamshire, United Kingdom Role and Responsibilities Designs and develops statistical programs in support of clinical research analysis and reporting activities. Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities. Maintains statistical programming documentation as appropriate. Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables. Performs activities in compliance with departmental processes and procedures. Collaborates effectively with statistical programming and cross functional team members and counterparts to achieve project goals. Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for the position. May contribute to departmental innovation and process improvement projects. Required and Preferred Skills Advanced Analytics Analytical Reasoning Biological Sciences Biostatistics Clinical Trials Data Modeling Data Privacy Standards Data Quality Data Savvy Detail Oriented Good Clinical Practice (GCP) Report Writing Research Ethics Researching Statistical Analysis Systems (SAS) Programming Statistics Technologically Savvy