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Regulatory Ops Project Sr. Analyst

Job Location: PA - Berwyn

Regional Description: Northeast

Job Number: 00574295

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- Job description

Join Accenture and help transform leading organizations and communities around the world. The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance. Choose Accenture, and make delivering innovative work part of your extraordinary career.

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

Regulatory Operations Project Coordinators 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 (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
  • Acting as a role model in both performance and team morale
  • Being prepared to deploy on-site to support publishing projects
  • Following all Internal standards including: Standard Operating Procedures, Guidance Documents and Policies throughout the duration of the project
  • Taking instruction and performing tasks as necessary as directed by reporting manager
  • Demonstrate the ability to walk a client through the overall publishing process and an explanation of the publishing tools and tasks used to produce electronic submissions
  • Perform Sr Project Coordinator tasks in the absence of the team Sr Project Coordinator
  • Willing to take on a leadership role within group

Basic Qualifications:

  • Minimum of a Bachelor’s degree
  • Minimum of 2 years of pharmaceutical industry or regulatory service provider experience
  • Minimum of 1 year of using publishing tools, internal tools, and document tracking tools to produce regulatory submissions

 

Preferred Qualifications:

  • Knowledge in handling registrations and maintenance of pharmaceutical products from a regional or local perspective
  • Bachelor’s degree in life sciences
  • General knowledge of the drug development life cycle and the high-level content of a submission
  • Well-developed presentation and/or training skills

Professional Skills:

  • Proven success in contributing to a team-oriented environment 
  • Proven ability to work creatively and analytically in a problem-solving environment 
  • Desire to work in an information systems environment 
  • Excellent leadership, communication (written and oral) and interpersonal skills

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 (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

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

Accenture is a Federal Contractor and an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.

Equal Employment Opportunity 
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.

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

Accenture is committed to providing veteran employment opportunities to our service men and women.

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