We are looking for a Translator / Regulatory Associate Swedish Native Speaker to provide proactive monitoring and surveillance on changes in the global regulatory landscape covering the drug development lifecycle starting from preclinical through commercialization as well as the medical devices from concept stage to market.
This position will provide broad support on clinical, pharmacovigilance and manufacturing quality activities and requests.
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.
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 Swedish and Finnish
Proficient in at least Swedish and Finnish 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 communicator - - both written and oral - in a multi-discipline team environment
Proficient in the navigation of intelligence database(s)
Experience in the biotech / pharmaceutical industry
Experience with understanding and interpreting regulatory guidelines and documents
Strong understanding of the commercial aspects of the healthcare market.
We invite you to join IQVIA™
IQVIA recognized by Great Place to Work as the second best company to work for in Spain (March 2018)
FORTUNE Magazine's World's Most Admired Companies list for the third year in a row.
Recognised by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO)
Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year. A site-nominated award recognising contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity.
IQVIA™ named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.
IQVIA™ is an equal opportunity employer . We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other "protected status.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us .
You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career goals, we are here to ensure you get there!