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    Reg Affairs Assistant

    Thermo Fisher Scientific
    0-2 years
    Not Disclosed
    Remote
    10 Oct. 10, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Work Schedule

    Standard: Monday to Friday
    Environmental Conditions: Office

    Job Description

    • Provide administrative support to the department, including travel arrangements, expense coordination, meeting planning, and presentation preparation.
    • Manage the document archiving and retrieval process, ensuring proper maintenance of archives for departmental processes, training materials, and regulatory metrics.
    • Assist in the management of Standard Operating Procedures (SOPs) and Work Procedure Documents (WPDs).
    • Help revise and maintain the department's webpage as needed.
    • Support the maintenance of utilization and resourcing tools.
    • Assist with the archiving of documents and submissions.

    Education and Experience

    • High school diploma or equivalent; relevant formal academic or vocational qualification preferred. Technical positions may require a specific certification.
    • Previous experience providing the knowledge, skills, and abilities to perform the job (minimum of 2 years). Prior experience in the pharmaceutical or CRO industry is preferred.

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