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    Lifescience Regulatory Svs Associate

    Accenture
    1-3 years
    Not Disclosed
    Bengaluru
    10 June 3, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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 Opportunity: LifeScience Regulatory Services Associate at Accenture

    Skill Required: Regulatory Services - Life Sciences Regulatory Affairs
    Designation: LifeScience Regulatory Services Associate
    Qualifications: Bachelor of Pharmacy
    Experience: 1 to 3 years

    About Accenture

    Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities. Visit us at www.accenture.com.

    Job Description

    What Would You Do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, including research laboratories, clinical trials support, regulatory services, pharmacovigilance, and patient services solutions. Employees in this area will be part of one of the sub-offerings: Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life by improving outcomes through a patient-centric approach, connecting scientific expertise with unique insights into the patient experience.

    Key Responsibilities:

    • Perform regulatory operations tasks, including bookmarking and hyperlinking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities.
    • Review and transform source documents.
    • Conduct Quality Control (Document QC) checks for all submission components.
    • Collect, collate, and evaluate scientific data gathered as part of R&D.
    • Advise on legal and scientific restraints and requirements.
    • Ensure the organization's products comply with current regulations.
    • Build regulatory submission strategy, author CMC documents, and health authority packages.

    Desired Skills:

    • Adaptable and flexible
    • Ability to perform under pressure
    • Problem-solving skills
    • Results-oriented
    • Ability to work well in a team

    Roles and Responsibilities:

    • Solve routine problems, largely through precedent and referral to general guidelines.
    • Expected interactions are within your own team and with your direct supervisor.
    • You will receive detailed to moderate instructions on daily work tasks and detailed instruction on new assignments.
    • The decisions you make will impact your own work.
    • You will be an individual contributor as part of a team, with a predetermined, focused scope of work.
    • Please note that this role may require you to work in rotational shifts.

    Join Accenture and be part of a team that is making a global impact by enabling leading biopharma companies to improve patient outcomes through innovative regulatory services.

    For more information and to apply, please visit our Careers Page.

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