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Reg Affairs Assistant

2+ years
Not Disclosed
10 Oct. 30, 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, 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

Job Title: Administrative Support Specialist
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office

Job Description:

  • Provide administrative support to the department, including travel arrangements, coordination of expenses, meeting planning, and preparation of presentations.
  • Manage the document archiving and retrieval process, maintaining archive areas for departmental processes, training materials, regulatory metrics, and business development documentation.
  • Assist in the management of Standard Operating Procedures (SOPs) and Work Practice Documents (WPDs).
  • Support the revision and maintenance of the department webpage as needed.
  • Help maintain utilization and resourcing tools.
  • Assist with the archiving of documents and submissions.

Education and Experience:

  • High school diploma or equivalent, along with relevant formal academic or vocational qualifications. Technical positions may require a certificate.
  • Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to at least 2 years). Prior experience in the pharmaceutical/CRO industry is preferred.