Oferta


Project Manager - Pharmaceuticals
We are a preclinical-stage biopharmaceutical company focused on the development of novel chemical entities for the treatment of inflammatory chronic diseases such as multiple sclerosis and scleroderma. Based in Córdoba, Spain, we are on a solid growth trajectory and have a highly energized and accomplished team. We are seeking a highly motivated individual to join us as a Project Manager to actively participate in all daily project management activities in support of IND/CTA of our lead products, and other milestones.
 
Essential duties and responsibilities include but are not limited to the following:

• Manage the transition from drug discovery to preclinical development, and to PhaseI/Proof of Concept (POC) clinical trials.
• Responsible for planning and developing the protocols in conjunction with a toxicologist who will be available through the CRO, as well as for the implementation and the operational and financial follow-up of the preclinical studies.
• Manages all daily project management activities, including project schedule development, project budget, project communication, staffing activities, status reporting, and resource plan development.
• Ensures scientific research, clinical studies, or biomanufacturing projects are completed on time, on-schedule and within budget.
• Recording meeting minutes, tracking action items, preparing meeting agendas, coordinating global and sub-team activities and disseminating project information.
• Communication with Contract Research Organisations (CROs) to keep timelines on track
• Work closely with Quality System team to create full process and method characterization plans and studies/protocols.
• Review and validation of the studies documentation (DDP), analysis and discussion about the results with the CROs.
• Review and validation of the writing of the preclinical part of the regulatory documents (ODD, IMPD, IND, IB, etc).

Requirements:

• PhD or Bachelor’s Degree in Life/Technical Sciences
• Master or Excellent knowledge of regulatory requirements for Drug Development.
• Fluency in both written and spoken English and Spanish
• Experience (3-5 years) in the pharmaceutical industry within Pre-Clinical sector.
• Experience in Project management, regulatory preclinical development studies, including Tox-ADME, GLP environments, managing CRO relationships
• Proficient with PC based office computers and standard Microsoft Office applications
• Willingness to travel to collaborators’ facilities
• Good team skills and ability to work in an interdisciplinary and international environment
• Possess a high degree of personal responsibility

If you are interested in applying for this opportunity, please submit your CV to info@vivacellspain.com , cover letter and salary requirements.
 
 
 
 
ENVIAR CURRÍCULUM
 
Permalink  
 
Desarrollado por Web4Bio