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People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.
Pharmaceuticals Processes professionals enable the processes involved in creating a new drug/therapeutic agent, from initial to manufacturing/distribution to marketing/sales and all related processes.
Regulatory Operations Managers are subject matter experts in multiple areas of regulatory operations. As part of project teams, Operations Managers are the primary operational contact for clients on regulatory submission content and quality so that client input is reflected as appropriate in the submission, and the submission format meets regulatory authorities' stated requirements. Acting as or working closely with the Account Manager, in conjunction with the Project Manager, they track and resolve all budget, time, resource, and contractual issues to ensure smooth project deployment and maintenance. Additionally, the Operations Manager must be prepared to assist the department by helping to define and achieve department goals. In addition to their project management responsibilities, including monitoring and reporting on execution of deliverable through all program/project phases, Operations Managers also have direct supervisory responsibilities.
Reporting directly to the Regulatory Operations Associate Director, the Regulatory Operations Manager’s primary responsibilities will include the following:
- Oversees all activities conducted on the assigned team. Escalation point for all team members.
- Responsible as the team leader for being a role model to the entire publishing team
- Perform submission Quality Control, resulting in a high quality final product.
- Conduct issue resolution, communicating with the client and their functional areas to ensure that all issues are resolved in a compliant manner.
- Regular communication with the client, including face-to-face meetings, presentations, telephone, email, and conference calls.
- Provide project-specific training to internal staff as well as offer ongoing direction/guidance to all team members throughout the project duration.
- Develop milestones and timelines, relay these objectives to the team, and ensure that the team is successful in obtaining these goals.
- Ensure that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the duration of the project. Maintaining a strong working knowledge of SOPs, GCPs and Regulatory guidance applicable to project scope (including corrective action plans and identifying trends)
- Ensure that specific Project Specifications, if they exist, are strictly adhered to throughout the duration of the project.
- Act as the primary liaison between third-party vendors and Accenture to ensure all submission project expectations are met in a timely manner.
- Keep the project within budget by properly managing resources.
- Adhere to sound Account Management principles, accountable for delivery of contracted commitments within budget and accuracy of all project information including, forecasts, costing and timelines for projects associated with the assigned portfolio of projects; and minimizing EACs.
- Client relationship management, building relationships with clients and potential clients, leading to growth of assigned accounts
- Assist/lead departmental committees and innovation initiatives in the definition and achievement of standards and processes (e.g., continuous improvement, automation).
- Create and deliver presentations, internally and externally (to clients/industry)
- Responsible for development and management of direct reports
- Conduct performance reviews of team