Job Description

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 world’s 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.

 

Business Process Delivery professionals execute repeatable core business processes and/or technical transactions with a focus on efficiency, first-time quality and overall continuous process improvement.

 

Job Description

 

The Regulatory Operations Publishing Associate will be accountable for basic electronic submission tasks which underpin the Unit’s 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. 

 

Reporting directly to the Regulatory Operations Manager, the Regulatory Operations Publishing Associate’s primary responsibilities will include the following:

  • Project Document Processing including bookmarking, hyperlinking, identifying issues, and conducting initial RO 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.
  • Responsible for 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
  • Additional Responsibilities as required to include document level quality control, support internal development projects, and submission-level publishing activities.
  • This position has daily contact and interaction with peers in a team environment as well as with team leaders.
  • The position is indirectly exposed to clients through the identification of issues, and other written communications that may be escalated to a client.


Qualifications

Basic Qualifications

  • Bachelor’s degree or 4 years of experience working in an office setting doing administrative support or project coordination

Preferred Skills

  • Exposure to the Life Sciences industry preferable.
  • Understanding and basic experience in MS Office tools, Acrobat, and Windows
 

Professional Skills Requirements

  • Ability to identify problems/issues and follow directions to solve/resolve problems
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.


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