15 days old

Regulatory Operations Senior Submission Coordinator

Philadelphia, PA 19133
Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions underpinned by the worlds largest delivery network Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 469,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.

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 Senior Submission Coordinator will be accountable for providing technical guidance across all aspects of regulatory operations in order to ensure generation of the highest quality regulatory submissions for the client. Under the direction of an Operations Manager, they will be responsible for managing the daily tasks associated with publishing, assigning publishing tasks, resolving document issues, and daily communication with the client. They must also be prepared to perform presentations, both to the client as well as internally at Accenture. This role requires the holder to demonstrate a high level of regulatory operations expertise in one or more global regions e.g., US, Europe, Japan, Canada, Australia, Emerging Markets, etc .

Reporting directly to the Regulatory Operations Manager, the Regulatory Operations Sr Project Coordinators primary responsibilities will include the following:
Submission publishing in electronic and paper formats
Control submission content, being accountable for the receipt and workflow completion of all submission components, resulting in a high-quality final product
Conduct issue resolution, communicating with the client and their functional areas to ensure that all issues are resolved in a compliant manner
For some projects submissions, perform submission QC, resulting in a high-quality final product
Responsible for delivery of contracted commitments within budget and cost forecasting
Drive improved capacity management of team operational resources
Work with the Operations Manager to develop milestones and timelines, to relay these objectives to the team, and to ensure that the team is successful in obtaining these goals
Ensure that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the duration of the project.


Basic Qualifications:
Bachelors degree
Minimum of 3 years of experience with regulatory submission coordination and publishing to Global Health Authorities in electronic or paper formats, using Pharmaceutical Industry standard publishing software and tools
Minimum of 1 year of experience with project management in handling registrations and maintenance of one or more of the following: pharmaceutical, medical device, consumer and/or cosmetic products
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 and with Accenture.

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. Our rich diversity makes us more innovative, more competitive and more creative, which helps us better serve our clients and our communities.

All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

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

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

Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

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.

Categories

Posted: 2020-10-12 Expires: 2020-11-11

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Regulatory Operations Senior Submission Coordinator

Accenture
Philadelphia, PA 19133

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