1+ months

Regulatory Ops Publishing Associate

Berwyn, PA 19312

Join Accenture and help transform leading organizations and communities around the world. The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance. Choose Accenture, and make delivering innovative work part of your extraordinary career.

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.

Job Description

The Regulatory Operations Publishing Associate will be accountable for basic electronic submission tasks which underpin the Units electronic submission output service, including bookmarking and hyperlinking of regulatory documentation for submission to multiple regulatory agencies. Repetition of tasks is a part of this role, yet demands flexibility in taking on responsibilities connected to the role and an attention to detail to ensure high quality deliverables.

Key Responsibilities

+ Project Document Processing including a. Bookmarking b. Hyperlinking c. Identifying Issues d. Initial Reg Ops Reviews

+ Completion of assigned tasks with a high degree of quality in a timely manner and within budget

+ Use of MS Office and Adobe Acrobat programs

+ Use of Internal and External Publishing Tools

+ Follow all internal standards including Standard Operating Procedures, Guidance Documents and Policies throughout the submission lifecycle

+ Reading and learning external guidance documentation related to electronic submissions such as Health Authority Guidance documents or ICH guidance

+ Be prepared to deploy on site to support Regulatory Operations projects

+ Take instruction and perform tasks as necessary as directed by reporting manager

+ Document level Quality Control

+ Assistance with Accenture's internal development projects

+ Submission level publishing activities

+ Daily contact and interaction with peers in a team environment as well as with team leaders

+ Exposure to clients through the identification of issues, and other written communications that may be escalated to a client

Job requirement

+ Ability to work overtime hours as required


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Regulatory Ops Publishing Associate

Berwyn, PA 19312

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Berwyn, PA

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