Regulatory Operations Specialist +
Accenture - Philadelphia, PA

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Organization: Business Process Outsourcing (BPO) Service Delivery Operation

Location: Wayne, PA

Individuals within the BPO Service Delivery Operations (SDO) provide clients with proven solutions, proprietary software assets and industry best practices to deliver an outsourcing solution at a fraction of the cost required to run the process in house. The SDO model is based on the principle that efficiencies and economies of scale are achieved through procedural best practices and centralized relationships for our clients specializing in finance and accounting, procurement, customer service, human resources and other services. BPO SDO helps clients develop and deliver business process innovations with cutting-edge outsourcing services. These services transform enterprises and deliver high performance at lower costs. We offer a full array of BPO services founded on operational excellence and cost effectiveness.



resources can expect to:
Receive ongoing training to build and extend professional, technical and management skills in all areas

Enjoy our comprehensive and generous benefits package


Regulatory Operations Specialist

controls submission content, being accountable for the receipt and workflow completion of all submission components, resulting in a high quality final product.

Key responsibilities:
Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner

Communicates with the client, including, but not limited to, face-to-face meetings, presentations, telephone, email, and conference call interaction

Works with the manager to develop milestones and timelines, relays these objectives to the team, and ensures that the team is successful in obtaining these goals

Ensures that the team follows, and strictly adheres to, internal standards including standard operating procedures, guidance documents, and policies throughout the lifecycle of the submission

Ensures that specific project specifications, if they exist, are strictly adhered to throughout the lifecycle of the submission

Keeps the project within budget by properly managing resources

Acts as a role model to the entire publishing team


Basic Qualifications

Minimum four years of experience in electronic submissions and with eCTD

Minimum one year of experience in project management or in a team lead role

Preferred Qualifications

Knowledge of publishing software and tools used throughout the industry preferred

Professional Skill Requirements

Proven ability to work independently and as a team member

Excellent communication (written and oral) and interpersonal skills

Good organizational, multi-tasking, and time-management skills

Self-motivated with initiative and ability to work in a fast paced, high volume environment

Applicants for employment in the U.S. must possess work authorization which does not require now or in the future sponsorship by the employer

for a visa.

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

Accenture is an Equal Opportunity Employer.

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