Strong scientific skills
– Literature/reference searching
– Critical review of scientific literature and reports
Strong written communication skills
– Accurate and thorough summaries
– Comprehensive and clear messages
– Correct Medical terminology
Strong analytical skills
– Interpretation of research data and statistics
– Visual presentation of data (diagrams, tables, graphs)
At RegFile we are happy to support you with your Medical Writing.
When your Marketing authorisation is granted, many local regulatory activities are still required prior to commercial launch. These requirements vary significantly between countries, and we recommend you to carefully plan the marketing in collaboration with local experts.
Below some actions that usually involve Regulatory Affairs:
– Strategy for common packs and serialisation
– Application for Nordic VNR and similar
– Local review and approval of educational materials, when available
– Ensuring PV and GDP functions are in place, in accordance with local requirements
– Review and adaption of promotional material according to local ethical code
– Registration in local data bases and update of compendia such as Fass in Sweden and Felleskatalogen in Norway
At RegFile we are happy to support with the regulatory launch activities for the five Nordic countries. Contact info@regfile.se for more information.
A regulatory Medical Writer combines knowledge in both writing and science to produce fit for submission documents in compliance with current guidelines, templates, and standards. The RegFile team support you in producing high quality documents ready to be shared with agencies, such as: clinical and non-clinical overviews and summaries, Periodic Safety Update reports,
Briefing documentation for Scientific Advice and more.
Let us help you compile a comprehensive overview of your scientific results and conclusions or just give your “drafty draft” the final professional touch.
RegFile’s next contribution to Kunskapsportalen is the presentation ”eCTD overview”. Kurskatalog (learnifier.com)
Kunskapsportalen is a platform created by SweLife and contain trainings within product development, , business development, specific regulations and intellectual property. Swedish incubators and innovation offices are behind the initiative. Read more: https://swelife.se/kunskapsportalen-sjosatt%ef%bf%bc/
Create an account in Kunskapsportalen: Kurskatalog (learnifier.com)
Vi söker förstärkning inom regulatory. Har du några års erfarenhet från industri eller myndighet – välkommen att söka! Se hela annonsen här:
RegFile AB
Eklundshovsvägen 1G,
752 37 Uppsala, Sweden
info@regfile.se
