Design of global, EU affiliate and USA affiliate Medical Affairs Standard Operating Procedure (SOP) documentation.
- Determine and agree on a list of core SOP documentation required for the newly created Medical Affairs departments working in the clients worldwide sites.
- Design, author and deliver the agreed list of SOP documentation
- Within the EU, SOP documentation will need to be duplicated and tailored for each applicable country, to ensure alignment with the correct local laws and regulations.
- In the first instance, EU documentation will be tailored for the UK, France, Germany, Italy, Spain, with a scope to expand the project to all ensure compliance with all EU member states.