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.
In today’s business environment, growth isn’t just about building value—it's fundamental to long-term business survival. So how do organizations sustain themselves? The key is a new operating model—one that's anchored around the customer and propelled by intelligence to deliver exceptional experiences across the enterprise at speed and at scale. You will deliver breakthrough business outcomes for clients—by harnessing talent, data and intelligence to revolutionize their operating models.
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
- 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 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.
The safety and well-being of our candidates, our people and their families continues to be a top priority. Until travel restrictions change, interviews will continue to be conducted virtually.
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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We have an unwavering commitment to diversity with the aim that every one of our people has a full sense of belonging within our organization. As a business imperative, every person at Accenture has the responsibility to create and sustain an inclusive environment.
Inclusion and diversity are fundamental to our culture and core values. Our rich diversity makes us more innovative and more creative, which helps us better serve our clients and our communities. Read more here
Equal Employment Opportunity Statement
Accenture is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation.
Accenture is committed to providing veteran employment opportunities to our service men and women.
For details, view a copy of the Accenture Equal Opportunity and Affirmative Action Policy Statement.
Requesting An Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Accenture and have accommodation needs for a disability or religious observance, please call us toll free at 1 (877) 889-9009, send us an email or speak with your recruiter.
Other Employment Statements
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.
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