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Reg Affairs Assistant

2+ years
Not Disclosed
10 Nov. 11, 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

Job Title: Administrative Support Specialist

Location: [Insert Location]
Job Type: Full-Time


Job Description:

As an Administrative Support Specialist, you will provide critical administrative assistance to the department, ensuring smooth operations and supporting a variety of functions including travel arrangements, meeting coordination, and document management. Your responsibilities will include:

  • Administrative Support: Provide support with travel arrangements, coordination of expenses, planning and organizing meetings, and preparing presentations.
  • Document Management: Oversee the document archiving and retrieval process. Maintain archives for departmental processes, training materials, job aids, regulatory metrics, and business development documentation.
  • SOP and WPD Management: Assist in the management of Standard Operating Procedures (SOPs) and Work Practice Documents (WPDs), ensuring they are updated and compliant.
  • Webpage Maintenance: Help with the revision and maintenance of the department’s webpage, ensuring it stays current and relevant.
  • Utilization & Resourcing Tools: Assist in maintaining tools for resource planning and utilization tracking to support departmental efficiency.
  • Archiving & Submissions: Assist with the archiving of documents and the submission process to ensure compliance and timely processing.

Education and Experience:

  • Education: High School diploma (or equivalent) with relevant formal academic or vocational qualifications. Technical positions may require a certificate.
  • Experience: At least 2 years of relevant experience that provides the knowledge, skills, and abilities to perform the job. Prior experience in the pharmaceutical or Contract Research Organization (CRO) industry is preferred.

Skills and Competencies:

  • Strong organizational skills with attention to detail.
  • Proficiency in document management and archiving systems.
  • Excellent communication skills, both written and verbal.
  • Ability to manage multiple tasks efficiently and meet deadlines.
  • Familiarity with SOPs, WPDs, and compliance documentation.
  • Basic understanding of webpage maintenance and resource management tools.

Reasonable Accommodations:

[Insert Company] is committed to providing reasonable accommodations to individuals with disabilities during the application and interview process. If you require assistance, please reach out to us directly.


Recruitment Fraud Notice:

[Insert Company] has discovered instances of fraudulent recruitment activities. Please be cautious when sharing personal information during the hiring process. For more details on how to protect yourself, review our Recruitment Fraud Notice.