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 425,000 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.

This role resides within Accenture's Applied Life Sciences Solutions (ALSS) group. This group helps clients make a meaningful impact on patients’ lives by combining new science with leading-edge technology. We’re working with our clients to revolutionize how medical treatments are Discovered, Developed and Delivered.  Helping 90% of the Fortune 500 life sciences companies (including all of the Top Ten) with 15,000+ life sciences professionals in 50+ countries.

 

Clinical Operations services we provide:
  • Clinical data management services
  • CDISC based clinical data conversion services
  • Biostatistics and statistical programming services
  • Clinical data transparency and disclosure
  • Accenture data operations professionals leverage their domain expertise for authoring data management plans, EDC database design, data review, reconciliation and coding.

 
Accomplishments: 
  • Processing and/or authoring of over 6.5 million case files
  • Over 2,000 clinical databases created
  • Over 900 clinical databases locked

 
Clinical Statistics and Programming services we provide:
  • Collaboration with sponsor on Integrated Summary of Effective (ISE) and Integrated 

 
Summary of Safety Strategy (ISS): 
  • Pooling and analysis activities
  • ISS/ISE Statistical Analysis Plan (including Mock Table Listings and Figures)
  • ISS/ISE Analysis Datasets from pooled and standardized SDTM database
  • ADaM Compliance

 
Accomplishments:
  • Experience representing sponsors or preparing sponsors for FDA  Advisory Committee
  • meetings or respective regulatory authority
  • Extensive technical knowledge and industry-leading CDISC standards expertise
  • Proven track record includes the analysis of over 4,000 datasets

 
Regulatory Services we provide:
  • Clinical Trial and Drug Application Submissions
  • Clinical Data Transparency and Anonymization
  • RoW Marketing Authorization Submissions
  • Document and Dossier Re-formatting
  • License Maintenance Submissions
  • Dossier Consolidation, Gap Analysis and Remediation
  • Submission Continuity Management

 
Regulatory Accomplishments
  • 350+ clients 
  • One of the largest users of the FDAs electronic gateway
  • Support over 90 countries 

 
Regulatory Operations Managers are subject matter experts in multiple areas of regulatory operations. As part of project teams, Operations Managers are the primary operational contact for clients on regulatory submission content and quality so that client input is reflected as appropriate in the submission, and the submission format meets regulatory authorities' stated requirements.  Acting as or working closely with the Account Manager, in conjunction with the Project Manager, they track and resolve all budget, time, resource, and contractual issues to ensure smooth project deployment and maintenance.  Additionally, the Operations Manager must be prepared to assist the department by helping to define and achieve department goals. In addition to their project management responsibilities, including monitoring and reporting on execution of deliverable through all program/project phases, Operations Managers also have direct supervisory responsibilities.

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

 
  • Oversees all activities conducted on the assigned team.  Escalation point for all team members.
  • Responsible as the team leader for being a role model to the entire publishing team 
  • Perform submission Quality Control, 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. 
  • Regular communication with the client, including face-to-face meetings, presentations, telephone, email, and conference calls. 
  • Provide project-specific training to internal staff as well as offer ongoing direction/guidance to all team members throughout the project duration. 
  • Develop milestones and timelines, relay these objectives to the team, and 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. Maintaining a strong working knowledge of SOPs, GCPs and Regulatory guidance applicable to project scope (including corrective action plans and identifying trends) 
  • Ensure that specific Project Specifications, if they exist, are strictly adhered to throughout the duration of the project. 
  • Act as the primary liaison between third-party vendors and Accenture to ensure all submission project expectations are met in a timely manner. 
  • Keep the project within budget by properly managing resources. 
  • Adhere to sound Account Management principles, accountable for delivery of contracted commitments within budget and accuracy of all project information including, forecasts, costing and timelines for projects associated with the assigned portfolio of projects; and minimizing EACs.
  • Client relationship management, building relationships with clients and potential clients, leading to growth of assigned accounts
  • Assist/lead departmental committees and innovation initiatives in the definition and achievement of standards and processes (e.g., continuous improvement, automation).
  • Create and deliver presentations, internally and externally (to clients/industry)
  • Responsible for development and management of direct reports 
  • Conduct performance reviews of team 

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Qualifications

Basic Qualifications

  • Minimum of a Bachelor’s degree 
  • Minimum of 3 years of experience in a Life Sciences industry
  • Minimum of 3 years of experience in pharmaceutical regulatory operations
  • Minimum of 2 years of experience with managing clients and projects
  • Minimum of 2 years of experience with Pharmaceutical Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)

     

 

Preferred Skills

  • Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective
  • Proven regulatory generalist with a good knowledge of drug development
  • Excellent international regulatory understanding and experience in handling business process excellence
  • Experience with publishing software and tools used throughout the Pharmaceutical industry
  • Experience in coordination and publishing of regulatory submissions for Invesitigational or Marketing Applications to Global Health Authorities in electronic, and paper formats
  • Proven ability to establish reputation as a regulatory operations subject matter expert
  • Experienced Team Leader or People Manager, skilled in managing employees
 
Professional Skills:
  • Self-motivated individual with initiative and an ability to work in a fast paced, high volume environment
  • Ability to promote the professional growth of self and others to achieve individual and organizational goals. 
  • People oriented with a mindset for customer service
  • Ability to travel
  • Excellent communication (written and oral) and interpersonal skills
  • Excellent organizational, multi-tasking, time-management skills; effective at managing many competing projects and consistent ability to fulfill commitments
  • Proven abilities to lead and/or work with multidisciplinary project teams across multiple geographic locations to build collaborative relationships
  • Proven ability to establish excellent working relationships with clients, peers and team members through integrity
  • Proven abilities to anticipate and address stakeholder needs in problem solving and risk mitigation


 

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.

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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