TRABAJO REGULATORY AFFAIRS LEAD STUDY BARCELONA, BARCELONA

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...

Develop and maintain relevant study plans (e... clinical study protocol (csp) through to clinical study report (csr)) in accordance with relevant az sops...

) • perform study lead activities for less-complex studies (e... • supports the study lead (gsad, gsd) with developing and maintaining relevant study documents/plans...

• lead clinical-regulatory authoring teams during the regulatory response period up through approval... the clinical regulatory writing director is encouraged to:...

Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence providing guidance and support to study teams...

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

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

study guide documentation, different study instructions, study newsletters, financial disclosure summary tables, invoices) to support all different roles of the...

Supports the review of the clinical study report external: supports development of investigator/site relationships to support site selection and study start up activities...

For associate director role, experience of program design knowledge of the technical and regulatory requirements related to the role leadership capabilities to be...

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

Pharmacovigilance), clinical research, or regulatory affairs solid knowledge in drug safety related processes (incl... reports events or reactions as required by...

The role will be focused on product demand, strategic projects lead and execution, customer experience and operational improvement...  drive the necessary processes...

The director will lead the ta group, liaise with subject matter experts, manage vendors and collaborate with global and local therapeutic leaders to produce engaging...

The gpd may also act as the lead for cross-functional teams in delivery of clinical program team (cpt) activities assigned... the gpd may provide project leadership...

Proactively keeps the lead programmer updated on progress of deliveries...   desirable skills/experience: broad experience across multiple therapeutic areas and...

At least 2 years of experience should demonstrate full responsibility as a study data manager, or equivalent roles in in a scientific, data-driven position in the...