Regulatory Documentation (PDRD) is part of the PD Regulatory organization. PDRD interprets the needs of worldwide health authorities, defining and executing the content and documentation strategy to support development and maintenance of global licenses. PDRD leads documentation deliverables across all therapeutic areas and phases of product development, from entry in to human to product divestiture. Leading a local or global team of Clinical Project Managers (CPM) or Regulatory Documentation Scientists (RDSes), the Regulatory Documentation Team Lead (RDTL) provides strategic oversight, leadership, management, coaching, and functional expertise to their direct reports, thus ensuring delivery of regulatory documents for assigned molecules, documents assigned to their direct reports, and/or other functional projects. The RDTL supports CPMs and RDSes in defining the content and documentation strategy for molecular programs, and oversees delivery of documents and filings by Regulatory Documentation Teams. This includes oversight of the documentation strategy and review of documents in support of molecular programs. Partnering with stakeholders and business leaders across functions, the RDTL is accountable for timely delivery of high-quality, compliant regulatory documents. Engage in Site Leadership activities to protect site culture and overall engagement. May also work on complex projects to support and coordinate assigned deliverables, and to guide the efforts of multiple staff members. The RDTL may represent and advocate for the department in key internal and external meetings, through various communications channels, or in other ways.
Major Responsibilities and Accountabilities:
- People Leadership, Management and Development
- Leads a global/local team of Clinical Project Managers (CPMs) and/or Regulatory Documentation Scientists (Regulatory Documentation Team) in support of multiple products within a single therapeutic area or cluster of therapeutic areas.
- Acts as a key strategic thought partners for clinical scientists and other team members on the development and writing/editing Protocols, Protocol Amendments and Informed Consent Forms (ICF).
- Leads medical writing and editing for Late Stage Clinical Development programs by partnering closely with cross-functional stakeholders.
- Leads the group responsible for the development and collaborative authoring/editing of protocols including drafting/editing, coordination of review and adjudication process and project management aspects such as timelines.
- Provides Line Management, direction, and leadership to Regulatory Documentation Scientists in order to maximize their capability to produce high-quality regulatory documents for their projects.
- Leads and/or supports knowledge sharing activities with their direct reports and the broader department.
- Identifies resource needs and recruits, trains and develops appropriate talent, ensuring ongoing compliance with Company and regulatory standards.
- Plans the resource requirements, skillset and interactions needed to deliver or execute documents
- Responsible for scheduling and assigning documents and projects to CPMs/RDSes, working collaboratively within PDRD for internal and external resource planning.
- Conducts ongoing performance management dialogue and completes the required steps of the performance management cycle.
- Conducts individual development/career discussions.
- Actively contributes to the performance calibration, talent management, and succession planning process.
- Leads by example and creates a positive work environment by encouraging mutual respect, innovation, and accountability at all levels (local, global, functional, projects/programs).
- Leading by example, advocates for and drives changes within the organization
- Accountable for the approval of all functional and project spend of their employees (as appropriate by site).