Accenture Regulatory Operations Submissions Coordinator in Overland Park, Kansas
Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Interactive, Technology and Operations services—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 674,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities. Visit us at www.accenture.com (https://blog.accenture.com/nacandidatemarketing/2021/03/24/updated-accenture-boilerplate-new-of-employees/www.accenture.com) .
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Operations is one of four services that make up one Accenture –the others are Strategy and Consulting, Interactive and Technology.
The Regulatory Submissions Coordinator within Accenture will perform project coordination of regulatory submissions, defining and producing all high-end publishing tasks along with associated documentation. Expectations for this role is that it requires enormous attention to detail, willingness to mentor, and initiative to be a motivator for the team and the organization. The Regulatory Submissions Coordinator’s primary responsibilities will include the following:
Document level quality control
Project coordination, including Client interaction in person, via phone and email
Issue management of both client and publishing issues
Submission publishing electronic and paper formats
Creation of electronic media for client or submission deliverables
Participation in client teleconferences by taking meeting minutes and distributing these minutes to the team members
Delivery of contacted commitments within budget
Participation in the development of internal projects
Creation and delivery of presentations for departmental training and new hire training
Being prepared to deploy on site to support publishing projects
Follow all internal standards including standard operating procedures, guidance documents and policies throughout the duration of the project
Perform Senior Project Coordinator tasks in the absence of the team Senior Project Coordinator
Minimum of 1 year of regulatory operations experience
Minimum of 1 year of experience with publishing and document tracking tools in eCTD format to produce regulatory submissions
Bachelor’s degree, preferably in life sciences
Knowledge in handling registrations and maintenance of pharmaceutical products from a regional or local perspective
General knowledge of the drug development life cycle and the high-level content of a submission.
Well-developed presentation and or training skills
As required by the Colorado Equal Pay Transparency Act, Accenture provides a reasonable range of minimum compensation for roles that may be hired in Colorado. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For the state of Colorado only , the range of starting pay for this role is $48,600 - $85,099 and information on benefits offered is here. (https://www.accenture.com/us-en/careers/your-future-rewards-benefits)
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Subject to applicable law, please be aware that Accenture requires all employees to be fully vaccinated as a condition of employment. Accenture will consider requests for accommodation to this vaccination requirement during the recruiting process.
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Requesting An Accommodation
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