Regulatory Publisher 2
Bangalore, Karnataka, Indien
Erf #178
Donnerstag, 20. Juni 2024
- 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 minimal guidance on day-today work and moderate guidance on new projects or assignments.
Weitere Details
- Tätigkeitsgruppe Regulatory Publishing
- Tätigkeitsfunktion Regulatory Publishing
- Entgelttyp Gehalt
- Beschäftigungsform Regular