As a Senior Medical Writer at ALK, you will play a key role in supporting our portfolio of products. You will join our team of highly-dedicated, skilled medical writers and work together with experts throughout the business, contributing with medical writing and communication perspectives to our activities.
Fields of responsibility
- Write and drive preparation of complex scientific and clinical documents for submission to regulatory authorities (e.g., clinical trial reports, clinical overview and summaries, briefing books, Q&A, pediatric investigational plans, protocols, investigator’s brochures)
- Write and contribute to high-quality manuscripts for peer-reviewed journals, as well as abstracts, posters and oral presentations for scientific congresses
- Interpret and communicate data generated from a variety of sources, including internal and external studies and research documentation
- Take a key role in cross-functional trial and project teams
- Contribute to development, optimisation and maintenance of processes, standards and systems within Global Clinical Development
- A relevant university degree in life sciences (Ph.D., M.Sc., M.D., or equivalent)
- >5 years of experience in the pharmaceutical industry, or in communication within the biotech/research environment
- Experience in preparing complex regulatory documents, including clinical dossiers and briefing packages
- A passion for written communication, founded upon solid clinical data-interpretation skills
- Exemplary and demonstrated stakeholder and project management skills
- A preference for working in an environment characterised by dynamic collaborations within and across functional areas
- A ‘can do’ attitude and ability to work to challenging timelines, whilst maintaining focus on adding value and delivery
- High standards for quality and an eye for detail
- Excellent written and spoken English; near fluency required
- Expertise in MS Office applications (Word, PowerPoint, Excel), Adobe Acrobat, and aptitude for grasping new applications
February 11th, 2020.
If this sounds like something for you, please send your application, in English, outlining your suitability and motivation for the position. If you have further questions, Victoria Fuller-Mikkelsen will be happy to answer, on +45 61913220.