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The Regulatory Ops Project Coordinator will perform project coordination of regulatory submissions, defining and producing all high-end publishing tasks along with associated documentation. This role should have the capacity to grow into a team lead and become a role model for the members on the team. 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. Reporting directly to the Regulatory Operations Manager, the Regulatory Operations Project Coordinator’s primary responsibilities will include the following:
- Document level quality control
- Project coordination, including Client interaction in person, via phone and email
- Workflow management
- 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 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.
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Our more than 600,000 people in more than 120 countries, combine unmatched experience and specialized skills across more than 40 industries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.