About Freyr
Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.
Why Freyr?
At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.
Join Our Team:
If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.
📢 To Apply:
Please apply to this job post or you can visit our Careers page for more openings
Visit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application.
Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!
Position : Medical Writer - Clinical
Location : United Kingdom
Duration : 1 year fixed term employment
Job Description:
* Comprehensive QC review of clinical sections of regulatory documents, including but not limited to, IBs, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), briefing packages for regulatory agency meetings/advice, including verification of all references and source data, to achieve the highest quality from a technical, regulatory, and compliance perspective. Verify internal consistency within a document and across related documents.
* Comprehensive content QC of clinical data/reports.
* Documentation of QC findings in the appropriate manner/ tool
* Content QC activity is applicable for all therapeutic areas, development phases, modalities and geographic regions.
* Checking of data presented in text and tables/figures against source documents for consistency and accuracy.
* Verification of the data/content (100%) including text, tables, and figure as per the source documents.
* Review for grammar, punctuation, spelling and compliance with specified styles/standards.
* Maintenance of the QC records and checklists.