We are currently recruiting for a Medical Writer position based in the Nordics.
The role will be for an initial 9-12 month contract.
• Write and/or review clinical regulatory documents such as clinical study reports and NDA/MAA submission documents
• Act as lead medical writer for submission documents and contribute scientifically and strategically at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing
• Contribute to the planning of data analyses and presentation for clinical study reports and submission documents; review statistical analysis plans and related documents
• Act as subject matter expert for regulatory requirements within clinical study and submission teams to ensure compliance of documentation to internal company standards and external regulatory guidelines
• Effectively collaborate with cross-functional stakeholders, including Therapeutic Area, Clinical Pharmacology, Biostatistics, Drug Safety, Clinical Operations, Preclinical Research, and Drug Regulatory Affairs
If this would be something of interest to you., or someone in your network, please reach out via E: email@example.com