Data Transparency Regty Document Analyst

at  Johnson Johnson

Integrated Data Analytics and Reporting (IDAR)
Sr. Analyst, Clinical Data Transparency
Position Summary:
Functions as a seasoned individual contributor in Clinical Data Transparency (DT), who works independently with minimal supervision. Helps establish and implement projects, programs, and processes in support of the organization’s overall DT strategy. Applies advanced knowledge of the DT field to establish best-in-class policies, procedures, and plans for the clinical registries, document anonymization, plain language summaries, data sharing and data anonymization.

Principal Responsibilities:

• Helps establish and implement programs and innovative initiatives for the organization to advance DT initiatives.
• Contributes to projects, programs, or processes for the DT area.
• Integrates methods based on analyses of trends and the competitive landscape to continually improve the organization’s DT 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.
• Process document sharing 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.
• Support continuous process and technology improvements.

Principal Relationships:
Internal:
Align, collaborate, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory Affairs, Data Sciences, Legal, Global Privacy, Data Transparency and others as needed.
External
Interact with vendors.

QUALIFICATIONS

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

• Helps establish and implement programs and innovative initiatives for the organization to advance DT initiatives.
• Contributes to projects, programs, or processes for the DT area.
• Integrates methods based on analyses of trends and the competitive landscape to continually improve the organization’s DT 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.
• Process document sharing 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.
• Support continuous process and technology improvements