KLIFO is looking for a talented and committed Medical Writer
KLIFO A/S is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling. KLIFO A/S has offices in Denmark, Sweden and Germany.
KLIFO now wants to appoint a talented and commited Medical Writer into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.
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 study protocols
• Generation of clinical study reports
• Generation of IBs and other documents related to the conduct of clinical trials, non-interventional studies according to the FDA/EMA and ICH guidelines
• Generation of patient facing documents, 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
• Prepare and give presentations when required
• Ad hoc tasks within the department and KLIFO
• Develop and review of SOPs to support department activities
The qualifications of the Medical Writer:
The Medical Writer should possess the f...