The Regulatory Document Manager is responsible for coordinating and managing 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 Lead to maintain partnerships with Therapeutic Areas, Clinical Registry, Publications, Regulatory Affairs, other cross-functional partners, and vendors to track internal and external requests for documents, locate documents in internal repositories, and review marked documents for appropriate protection of personally identifiable information (PII). The Regulatory Document Manager manages review of confidential commercial information (CCI) for dossiers to be made public under regulations including European Medicine Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information, as well as CCI review of documents for the YODA Project, registries, journals, and other external requests. The Regulatory Document Manager trains and advises reviewers on identification and justification for redaction of CCI. This position collaborates with Regulatory Affairs and coordinates expedited reviews of documents for freedom-of-information requests (eg, EMA Policy 0043).
The Regulatory Document Manager assists the Regulatory Document Lead in developing continuous improvement mechanisms to enhance the efficiency and accuracy of the document anonymization process, including developing effective working relationships with new vendors, testing and implementing new technologies, and tracking resource effort. The Regulatory Document Manager is a subject matter expert in data transparency and advises functional partners on aspects of PII and CCI.
- Bachelor’s Degree or equivalent
- At least 5 years of relevant pharmaceutical and scientific experience, at least 3 years of experience with regulatory, clinical, and/or nonclinical documents.
- Demonstrated experience with document handling, including working with document repositories
- Demonstrated project management experience, including tracking multiple simultaneous projects (eg, document reviews)
- Familiarity with global regulatory data transparency initiatives, such as EMA Policy 0070 and Health Canada PRCI
- Demonstrated written and verbal communications skills
- Demonstrated customer focus and solution-oriented experience
- Demonstrated interpersonal skills to build relationships with internal and external business partners
- Demonstrated leadership on cross-functional projects
- At least 1 year of data transparency experience
- Demonstrated experience handling complex data transparency projects; eg, for EMA Policy 0070 redaction proposal packages
- Good understanding of pharmaceutical clinical operations, including the roles and responsibilities of diverse stakeholders (clinical, regulatory, biostatistics, manufacturing, etc)
- Good understanding of pharmaceutical data transparency initiatives (eg, YODA Project, csdr.com, Vivli) and external trackers (eg, AllTrials, Final Rule Tracker)
- Familiarity with principles of PII, risk-based anonymization, and qualitative anonymization
- Familiarity with CCI and regulatory guidance on identifying and justifying redaction of CCI
- Basic understanding of global requirements for registration of clinical trials and posting of study results
- Demonstrated leadership in decision making and problem solving
United States-New Jersey-Raritan-
Janssen Research & Development, LLC (6084)