Non-clinical Drug Safety Senior Project Manager

**Define and implement the Pharmacometrics Plan for New Chemical Entities (NCE) and New Biological Entities (NBE) to support registration dossiers** - Develop the PMx strategy and contribute to modeling and simulation activities for non-clinical and clinical development projects. - Identify opportunities for MIDD to enhance project support. - Optimize study...

The clinical Biomarkers principal scientist will be responsible for defining the biomarker strategy, from biomarker identification, through clinical implementation, and up to companion diagnostics development, for multiple programs covering all three therapeutic areas, where needed. He/She will also be responsible for monitoring biomarkers in clinical...

The Senior Clinical Monitoring lead is fully accountable for all clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Phase I to III clinical studies in accordance with GCP guidelines and regulations. - He/she builds strong relationships with investigators and proactively acts as...

**Responsibilities**: - Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) - Partner with the study lead on oversight of clinical trial activities, including safety reviews...

**Purpose of the Position** Sr. Manager of Training will be responsible for developing and administering Job level training for each role within Clinical Operations. They are also responsible for developing and administering Therapeutic area training for the studies **Main Responsibilities & Technical Competencies** - Developing and executing training...

**Summary / purpose of the position** **To develop and maintain Core labelling documents and support USPI/other local product information throughout the product life cycle in accordance with Ipsen Processes for assigned product(s)** **To provide labelling guidance to support product teams and senior management in defining labelling strategy** **To provide...

**Purpose of the position** - Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of...

Please send your CV in English ! **Purpose of the position** - Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the...

**Job Title**:Senior Manager, CMC Regulatory Strategy - ** Division / Function**: Global Regulatory Affairs (GRA) - Prepare throughout the different phases of development CMC regulatory strategy roadmaps for assigned projects aligned with pre-clinical, clinical and LCM programs. - Collaborate closely with Pharmaceutical Development, and Technical Operations...

**Main responsabilities** Ensure clinical activities coordination & oversight: - Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc ): to verify timely collection of essential study documents, such as regulatory and...