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Reg Affairs Assistant

2+ years
Not Disclosed
10 Oct. 14, 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 Description

  • Provide comprehensive administrative support to the department, including travel arrangements, expense coordination, meeting planning, and preparation of presentations.
  • Manage the document archiving and retrieval process, ensuring proper maintenance of 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).
  • Contribute to the revision and maintenance of the department's webpage as needed.
  • Support the upkeep of utilization and resourcing tools.
  • Aid in 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 specific certification.
  • A minimum of 2 years of relevant experience that provides the knowledge, skills, and abilities necessary for the role, preferably in the pharmaceutical or contract research organization (CRO) industry.