PRA Health Sciences
Document Specialist (Non-Clinical)
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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