PRA Health Sciences

Document Specialist (Non-Clinical)


PayCompetitive
LocationRemote
Employment typeOther

This job is now closed

  • Job Description

      Req#: 111400
      Employer Industry: Healthcare Intelligence and Clinical Research

      Why Consider this Job Opportunity:
      - Competitive compensation based on geographic location, work experience, education/training, and skill level
      - Opportunity for career advancement and growth within the organization
      - Range of health insurance offerings for you and your family's needs
      - Global Employee Assistance Programme for 24-hour access to support professionals
      - Flexible country-specific optional benefits for work-life balance

      What to Expect (Job Responsibilities):
      - Generate quality and nonclinical basic structures and content for regulatory submissions
      - Ensure compliance with regulatory-authority document naming conventions
      - Edit submission documents, including cross-referencing and creating hyperlinks
      - Contribute to the preparation and maintenance of submission document templates
      - Participate in project teams related to deliverables standards

      What is Required (Qualifications):
      - Bachelor’s degree or equivalent industry-relevant experience
      - Expertise in using Document Management System in a pharmaceutical environment
      - Knowledge of nonclinical dossier structures and common file formats
      - Understanding of regulatory authorities’ requirements on electronic submissions
      - Experience working in cross-functional, global project teams

      How to Stand Out (Preferred Qualifications):
      - Advanced knowledge of publishing tools such as ISI Toolbox and Adobe Acrobat
      - Familiarity with eCTDXPress
      - Strong influencing skills and interactive communication
      - Ability to set and manage priorities, resources, goals, and project initiatives

      #HealthcareIntelligence #ClinicalResearch #CareerOpportunity #CompetitivePay #WorkLifeBalance

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      We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
  • About the company

      We are a global healthcare intelligence partner with everything you need to take your assets from concept to compound to cure.