Medical Project Manager (all genders) based in Berlin, Germany, with hybrid work options. You will act as the owner of medical data generation projects, combining scientific excellence with operational rigor to lead studies in line with SOPs, EU Directives, Medicines Laws, and applicable regulatory guidelines. Responsibilities include managing global governance and local non-interventional studies (NIS) and observational studies (OS), including post-authorization and risk-management studies required by authorities; overseeing investigator-initiated research (IIR) projects and institution-sponsored collaborative studies (ISCS); designing and implementing novel study designs (e.g., digital device settings); setting up new NIS, IIR, and ISCS; providing feasibility, concept, and operations guidance; building and leading OS core teams for local NIS; coordinating internal and external partners (e.g., CROs) across the project lifecycle; ensuring adherence to internal SOPs and external approvals and codices; managing production of study documents and systems; planning and controlling project budgets; training involved parties; overseeing analysis, documentation, archiving, and communication of study results; maintaining compliance with international regulatory standards (IFPMA, EFPIA, FDA, VFA, FSA, BfArM) and trial postings; contributing to Digital Innovation initiatives as needed. The role includes collaboration with internal therapeutic areas, business units, MSLs, and external authorities and service providers. The successful candidate will possess a life science degree with re

Medical Project Manager (all genders) based in Berlin, Germany, with hybrid work options. You will act as the owner of medical data generation projects, combining scientific excellence with operational rigor to lead studies in line with SOPs, EU Directives, Medicines Laws, and applicable regulatory guidelines. Responsibilities include managing global governance and local non-interventional studies (NIS) and observational studies (OS), including post-authorization and risk-management studies required by authorities; overseeing investigator-initiated research (IIR) projects and institution-sponsored collaborative studies (ISCS); designing and implementing novel study designs (e.g., digital device settings); setting up new NIS, IIR, and ISCS; providing feasibility, concept, and operations guidance; building and leading OS core teams for local NIS; coordinating internal and external partners (e.g., CROs) across the project lifecycle; ensuring adherence to internal SOPs and external approvals and codices; managing production of study documents and systems; planning and controlling project budgets; training involved parties; overseeing analysis, documentation, archiving, and communication of study results; maintaining compliance with international regulatory standards (IFPMA, EFPIA, FDA, VFA, FSA, BfArM) and trial postings; contributing to Digital Innovation initiatives as needed. The role includes collaboration with internal therapeutic areas, business units, MSLs, and external authorities and service providers. The successful candidate will possess a life science degree with re