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Translator (Regulatory) Baltics Languages
hace 1 mes
We are recruiting an awesome new team member to join us at our Madrid Center of Excellence office This position will provide broad support on monitor and analyze the changes and evolution of the local regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders for both drug and medical devices. y activities and requests.
**Responsibilities**:
- Assess regulatory intelligence information for relevance and impact to industry’s internal processes, drug development projects and/or regulatory strategies to create and enrich the IQVIA proprietary documents.
- Monitoring agency and professional websites, local specialized press, conferences and selecting documents to be integrated in line with the IQVIA scope, editorial and intelligence management processes.
- Identify business critical aspects and communicate effectively to internal and external stakeholders. This includes regular updates on new information that could impact clinical trial execution, pharmacovigilance activities, manufacturing quality as well as other ad hoc requests.
- Synthesize information from regulatory documentation as well as interaction with local country experts as needed.
- Share/Input data into systems or tools to enable effective knowledge management of country level operational intelligence data.
- Develop and refine regulatory intelligence processes and procedures to build efficiencies.
**Required Knowledge, Skills And Abilities Essential**
- Proficient in proof reading and editing in Baltics Languages (Latvian, Estonian, Lithuanian)and English
- Proficient in at least Baltics Languages and English
- Capability to work remotely with peers in an international environment.
- Good understanding of the drug development and commercialization process
- Ability to research, analyze and extrapolate critical regulatory information
- Highly organized and able to work independently to meet deliverable on time and on target
- Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization and externally.
- Attentive to details and focused on quality output.
- Effective communicatorboth written and oral - in a multi-discipline team environment
- Proficient in the navigation of intelligence database(s)