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Reg Affairs Assistant

2+ years
Not Disclosed
10 Sept. 11, 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

Work Schedule:
Standard (Monday-Friday)

Environmental Conditions:
Office-based

Job Description:

  • Provides administrative support to the department, including organizing travel arrangements, handling expense coordination, planning meetings, and preparing presentations.
  • Manages the document archiving and retrieval process, ensuring the maintenance of archive areas for departmental processes/mapping, department-level training materials, job aids, regulatory metrics, and business development documents.
  • Assists in the management of SOPs and Work Process Documents (WPDs).
  • Supports the revision and upkeep of the department's webpage as needed.
  • Assists in maintaining utilization and resourcing tools.
  • Supports the archiving of documents and submissions.

Education and Experience:

  • High school diploma or equivalent formal academic/vocational qualification.
  • Previous experience providing the necessary knowledge, skills, and abilities for the role (minimum of 2 years).
  • Prior experience in the pharmaceutical or CRO industry is preferred.