Udsendt dato23. maj 2022
Udløbsdato1. juni 2022
KLIFO is expanding and wants to engage a Medical Writer into a dynamic and experienced team within Clinical Operations Solutions. The right candidate can be located in the Danish, Swedish or German office.
The position as Medical Writer:
The MW is responsible for creation of medical and scientific documents and the factual and formally correct display of scientific results and findings within clinical trials and non-interventional studies according to the FDA/EMA and ICH guidelines, i.e.:
- Writing of clinical study protocols
- Generation of clinical study reports
- Generation of IBs and other documents related to the conduct of clinical trials and non-interventional studies
- Generation of patient facing material, e.g. patient information
- Support the project team in preparation and compilation of narrative safety reports
- Advise the project team in preparation of study documents
Furthermore, the MW will generate or contribute to the generation of regulatory documents, i.e.:
- Briefing documents for authority meetings (primarily EMA, FDA and national EU authorities)
- Orphan Drug Designation Applications (EU and US)
- Paediatric Investigation Plans/Pediatric Study Plans (EU/US)
- General Investigational Plans (US)
- Fast Track Designation Requests (US)
- Break-through Designation Requests (US)
- Non-clinical and clinical overviews and summaries for Module 2 (IND, MAA, NDA and BLA)
The qualifications of the Medical Writer:
- MSc in the life sciences field or related discipline, preferable with a PhD and a minimum of 3 years in a similar position in the pharmaceutical industry/CRO
- Experience in medical writing, particularly in the creation of Clinical Study Protocols/Clinical Study Reports conforming to ICH-GCP and writing of documents for EMA/FDA submissions
- Good statistical understanding in the area of descriptive statistics
- Ability to reproduce scientific data and complex issues accurately and in an understandable form
- Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
- Ability to translate client’s needs into writing
- Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
- Microsoft Office Skills
- Work within different therapeutic areas and with tasks of varying complexity
- A heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
- Build international client relations
- Use and elaborate your competences and experience
- Work in an interactive, flexible and positive working environment
Our core ambition is to support our clients by advancing the progress of their drug development projects, and over the past decade, we have grown to a point, where we can offer all the necessary end-to-end expertise and competences to achieve this.
It has enabled us to partner with both biotech and pharmaceutical companies and assist them in navigating the drug development process and successfully bring their products to market. Our more than 150 highly-qualified staff, all with industry experience, offer expert consulting and operational services throughout the entire drug development process.
Our solutions span all areas of drug development. No matter your need, or where you are in the drug development process, we can assemble a team of experts appropriate to the task at hand. We can support you by:
- Providing your organisation with the right expert advice at the right time
- Being a strategic partner throughout the entire drug development process
- Being a reliable supplier to take care of all your project needs
Whether your organisation is pressed on time, resources or expertise, we are able to assemble a team of relevant expert consultants to assist you. We strive to build flexible and trust-based partnerships, in which we work as an integrated part of your team to deliver solutions that are not only cost-effective and compliant, but also tailored to your project-specific needs. This approach to working with our clients has deep roots in our core values.
KLIFO has operational sites in Copenhagen, Denmark, Munich, Germany, Lund, Sweden and Eindhoven, the Netherlands.
Please apply as soon as possible – interviews will be held on an ongoing basis.