Regulatory Publisher 2
3 days ago
Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.
- Minimum Education Requirement - Bachelor’s degree or international equivalent in life sciences or computer science
- Minimum Experience Requirement - 02 to 05 years of relevant work experience
- Acts as primary publisher of assigned regulatory documents according to SOPs within established timeframes.
- Word formatting and document publishing of regulatory documents to meet local, regional, and ICH regulatory and technical requirements.
- Compilation and review of the source documents for regulatory publishing deliverables.
- Manage publishing workload responsibilities effectively as required to meet all timelines for all deliverables and milestones.
- Works closely with cross-functional teams to ensure the documents are of high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals.
- Performs quality control review of published documents as per client and regulatory agency specifications.
- Proactively identifies and escalates publishing issues as necessary. Proposes solutions for technical publishing issues.
- Provides strategy on planning and publishing timeframe required for assigned publishing projects.
- Actively participates in global publishing meetings to ensure publishing processes are consistent across regions.
- Good ability to work in cross functional teams. Works independently to drive publishing process for assigned publishing projects.
- In-depth understanding of drug development process, clinical research design and methodology, ICH GCP guidelines, federal and local regulations.
- Strong proofreading, editing and research skills and excellent attention to detail.
- Good written and oral communication skills.
- Receives mínimal guidance on day-today work and moderate guidance on new projects or assignments.
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