Principal Documentation Director (Doc Lead)
About the Job
To drive the development and implementation of the regulatory documentation strategy to meet time and quality performance goals for filing global regulatory dossiers as planned by the Immuno-Oncology Full Development Team(s).
Expected Areas of Competence
Leads the development of worldwide regulatory documentation strategy in support of the full development strategy to achieve target labeling objectives and timely approvals Ensures documentation strategy is integrated to support filings and approvals in the intended key markets Identifies opportunities to influence regulatory policy and climate with respect to documentation and dossier presentation in support of project goals and BMS preferences. Applies knowledge of internal and external guidances in providing feedback to the FDT on issues related to regulatory documentation.
Ensures effective planning and resourcing of all documentation activities required to produce high quality and consistent dossiers for submission to health authorities Coordinates documentation activities of multi-functional authors and reviewers from discovery, pharmaceutical development, clinical discovery and development; and manages the document review process to maximize speed and quality on behalf of the FDT Contributes to the development of effective documentation processes and standards; implements the processes to support FDT goals and ensures maintenance of PRI documentation standards In conjunction with appropriate disciplines, identifies and ensures management of external documentation support when required In conjunction with appropriate disciplines, identifies, and fulfills documentation training needs for project authors Supports the FDT core team members in the development and management of key dossier messages and issues; ensures their appropriate integration into the documentation in a consistent way Drives the document prototyping and preparation processes to ensure
- coordination and efficient use of messages between internal development plans, IND and NDA documentation
- appropriate prioritization of critical versus non-critical path activities
Critically reviews project-specific model documents, key data texts and displays during dossier prototype creation and facilitates reaching a consensus at key findings/ final document review meeting. Influences the FDT in tracking milestone activities and proactively identifies any issue(s), particularly the ones with a potential to impact the dossier quality or timelines In conjunction with the team members, manages and coordinates responses to dossier-related health authority questions
MD/PhD or equivalent, with thorough understanding of scientific principles and hypothesis testing and at least 8 years of pharmaceutical regulatory documentation. Demonstrated strong writing skills as evidenced by good quality writing in publications in peer-reviewed journals or in regulatory documentation. Analyzed and interpreted complex data from a broad range of scientific disciplines.
At least one major filing (NDA / MAA). Significant experience in writing high-level summary documents (preferably clinical). Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities Worked successfully in a cross-functional project team; ability to lead/facilitate discussions and decision-making with cross-functional team members. Assessed the requirements and provided tools, information and/or training to external documentation resources in order to produce document(s) that meet sponsor’s documentation standards.