Job Description

Data Transparency Regulatory Document Analyst

Johnson and Johnson Innovative Medicines has an outstanding opportunity for a Data Transparency Regulatory Document Analyst within the Data Transparency team located in the UK, Western Europe, or East Coast US.

At Johnson & Johnson, what matters most is helping people live full and balanced lives. We focus on treating, curing, intercepting and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Our mission drives us!

Position Summary:

The Data Transparency Regulatory Document Analyst is responsible for completing the end-to-end process for anonymization and redaction of Janssen documents in compliance with standard operating procedures (SOPs) and global and local regulations. This position works closely with the Data Transparency Regulatory Document Manager and Regulatory Document Lead to track internal and external requests for documents, review marked documents for personal protected data (PPD) and oversee review of documents for confidential commercial information (CCI).

The Data Transparency Regulatory Document Analyst:

• Interacts with internal functional partners and external vendors to fulfill these tasks.
• Reviews clinical trial documents in scope for publication under the European Union Clinical Trials Regulation for PPD and assists with reviewing them for CCI.
• Assists with anonymizing dossiers to be made public under the European Medicines Agency\'s (EMA\'s) policy on Clinical Data Publication and Health Canada\'s Public Release of Clinical Information regulation, and assists with anonymizing documents for the YODA Project, registries, journals, EMA\'s policy on Access to Documents, and other external requests.
• Supports continuous improvement to improve the efficiency and accuracy of the document anonymization process, including testing and implementing new technologies and detailing resource effort.
• Is an authority on data transparency and may advise functional partners on aspects of PPD and CCI.

Principal Responsibilities:

• Supervise end-to-end process for anonymization and redaction of Johnson and Johnson documents
• Review marked documents for appropriate protection of PPD
• Assist with CCI review projects for submission dossiers and external requests
• Complete expedited reviews of documents for freedom-of-information requests
• Support continuous improvement to improve the efficiency and accuracy of document anonymization process
• Document resource effort to evaluate efficiency of document anonymization and review process
• Maintain awareness of industry and competitor developments in the field of data transparency and document anonymization
• Ensure compliance with department SOPs, Job Aids, policies, and regulatory guidance documents
• Complete training requirements and timesheets by due dates

Principal Relationships:

• Collaborate with and assist Data Transparency Regulatory Document Manager and Regulatory Document Lead to facilitate the identification of PPD and CCI in documents and to follow regulatory requirements.
• Interact with functional partners and vendors.

Qualifications

Education and Experience Requirements:

• Proven pharmaceutical/scientific experience or demonstrated ability with regulatory, clinical, and/or nonclinical documents is required.
• Data transparency experience is required.
• High school or secondary education required; Bachelor\'s degree preferred.

In addition, the following proficiencies are required:

• Proven experience with document handling, including working with document repositories
• Proven project management experience, including supervising multiple simultaneous projects (eg, document reviews)
• Demonstrated experience with data transparency projects; eg, for Health Canada proposal packages
• Familiarity with PPD and document anonymization or redaction
• Familiar with principles of CCI
• Understanding of data transparency initiatives (eg, YODA Project, Vivli)
• Proven written and verbal communications skills
• Proven interpersonal skills to establish relationships with internal and external business partners

Preferred knowledge, skills, and abilities:

• Basic understanding of clinical operations, including roles and responsibilities of diverse partners (clinical, regulatory, biostatistics, manufacturing, etc)

Who we are?

At Johnson & Johnson, we\'re on a mission to change the trajectory of health for humanity. That starts by creating the world\'s healthiest workforce. Through powerful programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Johnson & Johnson