Manages the process to verify, through risk-based independent audit, compliance of PV activities with national/international regulations and guidelines on Good Pharmacovigilance...
This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...
The candidate with be responsible for creating and maintaining Medical Affairs slide decks. The Medical Writer will collaborate with Medical Affairs stakeholders to create...
You will lead a team of QC Microbiology Analyst’s supporting site activities related to Bioburden and Endotoxin testing of utilities, in-process, drug substance and drug product...
Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product...
Ensure customer service level promises and logistics costs with the cluster VP & EMEA SC VP. In accordance with the Cluster Executive Committee, lead the Cluster Order Policy...
You will be responsible for leading global, complex extractables and leachables (E&L) projects with internal and external laboratories. You will work with site and global teams to...
Lead Global Med. Excellence and Stakeholder Engagement Team (Med. Communication, Med. Info, Capabilities and Learnings, Medical Service Hub, Medical Evidence Generation Management...
Contribute towards the development of novel biotherapeutics, focusing on human immunology and assay development. This is a research-based role, working to discover therapeutics for...
Your key responsibilities will be people management, coordinating screening workflows for projects at different discovery stages, and maintaining a versatile assay platform...
Create and Review regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals; Track status and progress of regulatory...
Ensuring clinical studies are conducted according to the study protocol, SOPs, ICH/GCP regulations, and study-specific manuals and procedures; Participating in the development of...
Isolate RNA and DNA from human samples (blood, tissue) in high throughput using laboratory automation/automated liquid handlers; Prepare libraries for RNA-Seq using a dedicated...
This position is responsible for the study-level management (prior to submitting to IRB/EC to closeout) of clinical studies, including preparation of applicable clinical study...
Develop and maintain excellent thought leader relationships in the field of rare disease specifically Fabry Disease, Pompe Disease and Batten Disease; Lead on medical initiatives...
Responsible for managing GCP and GVP Quality Management Systems of Research and Development activities in accordance with applicable legal, regulatory and other Quality standard...
Responsible for Neuropsychiatry products launch activities, cross-functional leadership and management of Medical Science Liaisons (MSLs). You will represent medical affairs at...
Moderna is seeking a talented, experienced, and motivated Senior Scientist to join the Immuno-Assays group to serve as a scientific expert and point of contact for the oversight of...