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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.
· 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
· 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
· 350+ clients
· One of the largest users of the FDAs electronic gateway
· Support over 90 countries
The Regulatory Operations Specialist 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, the Regulatory Operations Specialist is responsible for managing the daily tasks associated with publishing, assigning publishing tasks, resolving document issues, and daily communication with the client. The Regulatory Operations Specialist 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 Specialist's 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
· High level of communication with project team
· Regular communication with the client, including, but not limited to, face to face meetings, presentations, telephone, email, and conference call interaction
· Ensure that specific Project Specifications, if they exist, are strictly adhered to throughout the duration of the project
· Take instruction and perform tasks as necessary as directed by reporting manager
· Be prepared to deploy without extended notice
· Demonstrate the ability to work independently of a Regulatory Operations Manager
Ideal candidate profile
· Minimum of 3 years of pharmaceutical/regulatory industry experience
· Minimum of 1 year experience with project management in handling registrations and maintenance of one or more of the following: pharmaceutical, medical device, consumer and/or cosmetic products
· Bachelor's degree
· Experience with publishing software and tools used throughout the Pharmaceutical industry
· Experience in coordination and publishing to Global Health Authorities in electronic or paper formats
· A working knowledge of Pharmaceutical Regulatory Submission requirements as defined by International Conference of Harmonization and Global Health Authority Guidelines International regulatory understanding and experience in handling business process excellence
· Ability to support a multidisciplinary project team across multiple geographic locations to build collaborative relationships
· Establish excellent working relationships with clients, peers and team members through integrity, credibility, reliability and trust
· Establish confidence in one's regulatory abilities and develops long term trusting relationships with project team members and clients 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.
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