Regulatory and Start Up Specialist

IQVIA MedTech Clinical Solutions, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products. IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions. Italian...

**Start Up - Specialist**: - ** Minimum 1 year of experience working as Start - Up Specialist.**: - ** Serve as local expert in project start-up activities for a particular country or region.**: - ** Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues.**: - ** Collect, track and perform a quality...

Study Start Up Specialist, IQVIA Biotech - Italy - Homebased - IQVIA Biotech is looking for an experienced Clinical Study Start-up professional to join our Study Start-Up Unit. - The Study Start-up Specialists are responsible for conducting and facilitating specific start-up activities that may include site identification, feasibility, essential document...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions. Italian...

Job Overview: A consultant is expected to have a comprehensive understanding of our operational processes and business objectives. Will work in specific projects according to his/her knowledge and experience Essential Functions - Help to define/enforce best practices and support management driven initiatives - Provide reports, analysis and offer...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions....

**Primary contact and liaison with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB submissions are made within the timelines agreed with project management and Start-up team.**: - ** Collect, track...

**Regulatory Affairs Specialist** At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As **Regulatory Affairs Specialist** in Italy, you will play a pivotal role in...

**Regulatory Affairs Specialist (maternity leave)** At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As **Regulatory Affairs Specialist (maternity leave)** in...

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...

Azienda internazionale presente sul mercato da oltre 20 anni, sta cercando una figura da inserire come Study Start Up/Regulatory Associate all'interno del dipartimento delle clinical operations. Tra le varie attivita', avrai il compito di fornire l'elenco dei documenti necessari per la presentazione iniziale a CA e CE per richiedere l'autorizzazione,...

Premi Tab per spostarti e passare al collegamento contenuto Seleziona la frequenza (in giorni) di ricezione di un avviso: Webuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l’energia idroelettrica, l’acqua, i green...

Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: Join our team of experts in regulatory...

e-work SpA ricerca Regulatory Affairs Specialist per start-up operante nell'ambito della produzione e commercializzazione di dispositivi medici chirurgici. La risorsa, assistita dal consulente esterno esperto e dalla direzione, si occuperà di preparare e gestire i fascicoli tecnici prodotti al fine di ottenere certificazioni ISO 13485, CE, FDA (USA) ed...

The COM is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially...

For our Clinical Chemistry Strategic Business Unit, based in Milan (Italy), we are looking for a: **Regulatory Affairs Specialist - Maternity Leave**: The Regulatory Affairs Specialist handles the Regulatory Affairs activities in the pre-market. The main accountabilities of the Regulatory Affairs Specialist are: Support registrations, understand the local...

Supporting for Identifying, mapping, analysing and maintaining updated all the information, market player and Regulatory Framework in SEE Countries of operation - Identify and maintaining strong relationships with Relevant Agencies representatives in SEE Countries of operation and supporting coordination with them - Attending meeting with local counterparts...

Webuild, nuovo nome di Salini Impregilo, è un player globale delle costruzioni specializzato nella realizzazione di grandi opere e infrastrutture complesse per la mobilità sostenibile, l’energia idroelettrica, l’acqua, i green buildings, il tunneling.   Espressione di 116 anni di esperienza ingegneristica applicata in 50 paesi dei cinque...

PROFILE: The resource will deal with the analysis of the content of the Authority’s provisions, also for aspects relating to the evolution of the regulatory context within the EU, ensuring the relevant communication within the company, ensuring their correct interpretation and supporting the company functions from time to time involved in the assessment of...