LAVORO SENIOR CLINICAL TRIAL REGULATORY

We’re looking for a  senior regulatory affairs manager  to lead and support regulatory activities across europe... senior regulatory affairs manager (remote - eu/uk) ...

• superior clinical research operational knowledge... • 6-8 years clinical trial management experience in the pharmaceutical industry or cro...

Strong understanding of gcp, regulatory requirements, and clinical trial methodologies... clinical section of the investigator’s brochure, protocols and clinical...

Req • knowledge of clinical trials - knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i...

Align with project and portfolio management (ppm) to identify key milestones for gra to meet business objectives, from clinical trial initiation, regulatory submission...

Base regulatory strategy recommendations on precedents and other regulatory    intelligence as well as regulations and guidelines...   minimum requirements/qualifications:...

The clinical trial assistant is responsible for providing operational and administrative support for the day-to-day execution of clinical trials following established...

Hirevo lifescience è la specializzazione di gi group, prima multinazionale del lavoro italiana, dedicata a valorizzare le esperienze, le competenze e il potenziale...

Prior experience in clinical trial development is essential, as the selected candidate will define regulatory processes, oversee implementation, and prepare key...

Strong understanding of gcp, regulatory requirements, and clinical trial methodologies...     provide clinical leadership within the core team, ensuring the...

Strong understanding of gcp, regulatory requirements, and clinical trial methodologies...   they ensure scientific and medical integrity in the development...

Gra, etc) and external key opinion leader/ investigator    management of the interaction with external cro and consultants to support the clinical pharmacology...

Accountabilities: work with gcsc planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines...

Strong knowledge of ich-gcp, clinical trial lifecycle, regulatory requirements, and cro/vendor management...   who we are looking for purpose the clinical project...

clinical research and program management experience working with clinical programs within medical affairs, clinical research, regulatory, cmc or other drug development...

Understanding of clinical trial design, execution, and regulatory requirements (e... external collaborators include academic and clinical researchers...

•   ensures study (s) compliance by maintaining and updating trial management systems, clinical trial management system (ctms), trial master file (etmf) and trial...

Ensure that clinical pathways activities align with regulatory standards and internal policies... experience with pathway modelling tools, health economics software...