[F-097] | SUBMISSIONS PUBLISHER/SPECIALIST 1-6

Freyr Solutions


Requirements: Submissions Publishing Team works closely with various stakeholders to ensure the timely completion of submission assemblies that adhere to Regulatory health authority guidelines for electronic/hard copy submissions. The incumbent will support global process; executing end - To - End submission assembly which includes submission publishing, quality control verification, finalization and dispatch to HA via Gateway or CD/DVD/Hard Copy **Responsibilities**: - Work closely with submission managers to produce high quality submission assemblies(eCTD/NeeS/Paper format) utilizing submission - Ready documents that adhere to internal and external electronic submission guidelines - Ensure submission assemblies meet the level of technical integrity required for health authority validation tools - Assist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right - First - Time submission assemblies - Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions - Manage regional submissions and support global submissions as a Publisher - Manage and/or mentor junior team members - Proactively communicate requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines.**Benefits**: Health Insurance, Full - Time CONDICIONES DEL EMPLEO Jornada laboral:Tiempo Completo Tipo de empleo:Trabajo Fijo Salario:A convenir Cantidad de vacantes:24 REQUERIMIENTOS Experiência Mínima:No especificado Sexo:Indistinto

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