Associate Director, Adjudication Operations

Job Summary

The Associate Director, Adjudication Operations will participate in all aspects of adjudication start-up activities, including but not limited to, compiling a committee membership, providing review and input into the Adjudication Committee Charter(s), developing the Adjudication Services Operational Plan, providing review and input into workflows and data capture forms, and providing input into the development of tracking tools and reports. The Associate Director, Adjudication Operations will also oversee, manage and support Adjudication vendors and build and maintain strong working relationships across functional units, committee members and service providers in support of the adjudication process.

Responsibilities

• Support Adjudication Activities
• Oversee, manage, and support Adjudication Vendor(s) with all aspects of contracted adjudication activities
• Partner to establish a project team inclusive of internal staff as well as members from the vendor project team
• Develop and deliver staff training as required
• Monitor workflow and status of adjudication activities
• Review and distribute event adjudication status reports and metrics to relevant stakeholders
• Provide input into client invoicing and vendor payment
• Serve as central point of contact and communications representing Adjudication Services on assigned project(s)
• Interface regularly with customers, both internal and external (including adjudicators)
• Attend internal and client team meetings
• Coordinate and conduct Adjudication Services Team Meetings and create and distribute meeting minutes
• Coordinate and conduct relevant sessions of adjudication meetings and create and distribute meeting minutes
• Ensure compliance with project budget, actively identifying out of scope work and escalating potential scope changes to appropriate individuals
• Manage execution of all aspects of the workflow pertaining to the processing of events for adjudication. This includes, but is not limited to, oversight of procedures for:
• Maintaining event tracking systems
• Event case processing: intake and triage, event linking, event de-activation, tracking, data entry, document processing (e.g., redaction of specified content), review of incoming event information for completeness and accuracy, content review, identification of missing required data and/or documents, generation of queries, query review and closure/re-issue
• Contacting site personnel to obtain missing data and/or documents
• Escalating open events for issue resolution and closure, in accordance with relevant Escalation Plan
• Completing First Review QC Checklists or Second Review QC Checklists (as appropriate), assembling dossiers
• Conducting event reconciliation processes. May directly perform QC of assembled dossiers, complete Second Review QC Checklists (as appropriate).
• Manage implementation of adjudicator workflows. This includes, but is not limited to:
• Implementation of adjudicator disagreement resolution processes
• Implementation of re-review and re-adjudication processes
• Processing of adjudicator requests for additional documentation
• Processing of adjudicator notifications of potential un-reported events
• Perform periodic and final project file reviews and ensure any findings are addressed
• Provide mentoring and/or training for less experienced Adjudication Services staff, as appropriate
• May participate in bid defenses or other presentations
• Work in accordance with the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs)
• Build and maintain good working relationships within the Adjudication Services department and across functional units
• Support Adjudication Committee Members/ Support Regulatory Inspections
• Provide feedback and support to members in support of adjudication activities
• Support contracts and payments to adjudication members
• Support inspections in as operational adjudication support SME

Qualifications

• Education Qualifications
• Bachelor’s Degree in a Life Sciences field and a minimum of 7 years’ of experience in pharmaceutical or biotechnology drug development (or equivalent experience)
• Master’s Degree in a Life Sciences field and a minimum of 5 years’ experience in pharmaceutical or biotechnology drug development required
• Experience Qualifications
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Knowledge of Adjudication process and working with adjudication committees or IRCs