Data Transparency Document Anonymization Specialist

We are seeking a Data Transparency Document Anonymization Specialist to join our Clinical Data Standards & Transparency team, Innovative Medicine, to be located in United Kingdom or India. The overall responsibility of the Data Transparency Document Anonymization Specialist is to maintain proper anonymization/redaction of personal and company confidential information per established company standards and regulations. Functions as a seasoned individual contributor in Clinical Data Transparency, who works independently with minimal supervision. Helps establish and implement projects, programs, and processes in support of the organization's overall Data Transparency strategy. Applies advanced knowledge of the Data Transparency field to establish best-in-class policies, procedures, and plans for delivery of anonymized/redacted documents in support of Clinical Registries, Policy 0070, PRCI, EU CTR, etc. Principal Responsibilities:

• Process document anonymization requests from receipt of request to delivery, prioritizing as required to deliver within required timelines and ensuring proper recording of completed milestones and reviewer feedback.
• Redact documents for protected personal data (PPD) as required following J&J practices and standard operating procedures.
• Assist with quality assessments of documents anonymized by vendors for PPD.
• Contribute to internal reviews of confidential commercial information (CCI), providing tools to reviewers and capturing redacted CCI across documents and in justification tables.
• Interacts effectively with multiple functions, clinical teams across all Therapeutic Areas and external vendors to communicate document requirements and to provide high quality results.
• Ensures compliance with departmental SOPs, Job Aids, policies and regulatory guidance documents.
• Leads discussions by proposing solutions on guidelines, standards, processes.
• Sound organizational and leadership skills, and the ability to balance multiple responsibilities and work under tight time constraints.
• Support continuous process and technology improvements.
• Helps establish and implement programs and innovative initiatives for the organization to advance Data Transparency initiatives.
• Contributes to projects, programs, or processes for the Data Transparency area.
• Integrates methods based on analyses of trends and the competitive landscape to continually improve the organization's Data Transparency strategy.
• Participates in all aspects of Data Transparency including compliance to regulatory policies and privacy regulations.
• Researches critical data quality issues to drive root cause assessment and mitigation planning.
• Supports development and maintenance of Data Transparency tools and activities.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Understands and applies J&J's Credo and Leadership Imperatives in day-to-day interactions with team.
  
  Education and Experience Requirements:
• A bachelor's degree in a scientific, technology or healthcare discipline, or equivalent experience
• At least 3 years of relevant pharmaceutical/scientific experience in a related discipline; e.g. medical writing, data management, biostatistics, clinical programming
• Strong understanding of at least one of the following: regulatory clinical trial disclosure requirements, translation of scientific content for a lay audience, anonymization of clinical data and documents, data sharing
• Demonstrated written and verbal communications skills
• Demonstrated customer focus
• Demonstrated interpersonal skills to build relationships with internal business partners
• Demonstrated contributions to cross-functional projects
Other:
• Proficient in spoken and written English