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.
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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
- 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.)
- 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
- 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
Equal Employment Opportunity Statement
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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