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    Service Delivery Ops Specialist

    Accenture
    7-11 years
    Not Disclosed
    Bangalore
    10 May 15, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Service Delivery Ops Specialist
    Skill Required: Regulatory Services - Life Sciences Regulatory Affairs
    Designation: Service Delivery Ops Specialist
    Qualifications: Master of Pharmacy
    Years of Experience: 7 to 11 years

    About Accenture:
    Accenture is a global professional services company specializing in digital, cloud, and security solutions. With expertise across more than 40 industries, Accenture offers Strategy and Consulting, Technology, Operations services, and Accenture Song, powered by the world's largest network of Advanced Technology and Intelligent Operations centers. With 699,000 employees serving clients in over 120 countries, Accenture embraces change to create value and shared success for clients, people, shareholders, partners, and communities.

    Responsibilities:

    • Perform regulatory affairs tasks in accordance with ICH guidelines and other Health Authorities.
    • Review and transform Source Documents and perform Quality Control checks for all regulatory submissions.
    • Collect, collate, and evaluate scientific data gathered as part of R & D.
    • Advise on legal and scientific restraints and requirements, ensuring compliance with current regulations.
    • Build regulatory submission strategy, author Regulatory documents, and health authority packages.

    Skills Required:

    • Life Sciences Regulatory Affairs expertise
    • Ability to manage multiple stakeholders
    • Ability to perform under pressure
    • Agility for quick learning
    • Negotiation skills
    • Problem-solving skills
    • Proficiency in Microsoft Excel; Veeva Vault Regulatory Module

    Roles and Responsibilities:

    • Analyze and solve moderately complex problems, potentially creating new solutions and adapting existing methods and procedures.
    • Understand the strategic direction set by senior management and align team goals accordingly.
    • Interact with peers, management levels, and clients, with guidance provided for determining methods and procedures on new assignments.
    • Decisions made in this role often impact the team and may involve managing small teams or work efforts at client sites or within Accenture.
    • Note: This role may require working in rotational shifts.
     

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