Project Manager II – Investigator Sponsored Research (ISR) and Collaborative (CO) studies (Sponsor Dedicated/Remote)
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment. Experience with regulatory...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position... preparation;Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA);Manage...
(FDA, EMA, ICH, USP). Partners cross-functionally with Quality Assurance, Manufacturing, Regulatory Affairs, and CMC teams...
inspections is a plus (FDA, MHRA and EMA);Strong communication skills;Strong quality mindset;Excellent written and verbal...
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
guidelines (e.g. ICH, EMA, FDA, etc.) Supports regulatory requests and inspections Supports the QC AD team to investigate...