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Lead Regulatory Publisher, Insight Publisher

2+ years
Not Disclosed
10 Nov. 22, 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

Company Description

Katalyst HealthCares & Life Sciences Inc. specializes in hiring entry-level and experienced candidates for contract research in clinical trials of drugs, biologics, and medical devices. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners to provide dynamic career opportunities.


Position Overview

Role: Lead Regulatory Publisher
Location: Remote/Onsite
Job Type: Contract


Key Responsibilities

  • Serve as the Lead Regulatory Publisher with oversight of publishing activities.
  • Utilize expertise in Insight Publisher for regulatory submissions.
  • Coordinate and execute publishing tasks for submissions across multiple regulatory platforms.
  • Maintain compliance with industry standards and regulatory guidelines.

Qualifications

  • Experience:

    • Minimum 6 years of regulatory publishing experience.
    • At least 3 years of hands-on experience with Insight Publisher.
    • Minimum 2 years of experience in a Regulatory Lead role.
  • Skills:

    • Strong expertise in regulatory publishing tools, specifically Insight Publisher.
    • Excellent organizational and communication skills.
    • Proven ability to manage and prioritize tasks effectively in high-pressure environments.

Additional Information

All candidate information will be handled confidentially as per EEO guidelines.