TRABAJO CLINICAL REGULATORY AFFAIRS LEAD BARCELONA, BARCELONA

• lead clinical-regulatory authoring teams during the regulatory response period up through approval... • lead development of the clinical submission communication...

Product realization (without responsibility for clinical aspects, usability, and pms)... asphalion is growing and we are looking for a regulatory affairs – medical...

We are looking for an it solution design expert to join our regulatory affairs team... 10+ years of experience in it technology development experience, preferably...

Guide internal teams for clinical programs in choosing the appropriate coas for clinical trials and provide input into the majority of clinical documents, throughout...

Additionally, the gpd may lead or contribute to improvement and change projects within clinical operations and/or other business areas, as well as potential line...

  the clinical project support specialist reports to cts team lead in gbs barcelona... locally main contact are the clinical operations manager 3 and 4, study...

regulatory compliance... clinical trials... provides safety support to the clinical development teams... regulatory and professional inquiries:  respond to inquiries...

Documentation preparation: prepare comprehensive regulatory documentation for medical devices, including ivds and medical device software, ensuring compliance with...

The lead will tackle a lead role for specific european and international markets and support/lead specific omap or regional projects and initiatives...

Collaborating in global initiatives to standardize processes within and across countries (collaboration with other local and global csas) assist with local language...

Desirable requirements basic understanding of clinical trials methodology... at morgan philips, we are looking for a knowledgeable clinical data manager to join...

Expert understanding of the clinical trial b usiness processes, end to end drug development process experience an advantage... prior working experience in analytics...

Desirable relevant clinical or biomedical ph... the clinical scientist is the link between the project team and all external clinical research for the program...

Prepare regulatory documentation and design processes with the quality and regulatory affairs teams to comply with the artificial intelligence regulation and other...

Pre-process process and analyze data from clinical trials including demographic clinical and device usability data... prepare regulatory documentation and design...

Extensive knowledge of clinical research regulatory requirements (incl ich-gcp) and demonstrated abilities in clinical study management processes and clinical/drug...

Strong understanding of regulatory requirements and guidelines for clinical trials, including ich-gcp and local regulatory requirements... in addition to your competitive...

) • perform study lead activities for less-complex studies (e... • participate in and/or lead departmental initiatives and/or sme function... • aggregation and communication...

Proactively address potential gaps and risks relevant to clinical development and clinical operations processes, while identifying valuable opportunities for continuous...

We would prefer for you to have: · scientific degree of a clinical nature · experience in training instructional design and content management · medical affairs...