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Scientific and Regulatory Specialist

  • PHARMINNOVA P.C.
  • Αθήνα
  • 7/5/2018

Στοιχεία αγγελίας

Σχέση απασχόλησης - Πλήρης ΑπασχόλησηΕλάχιστη Απαιτούμενη Εκπαίδευση - ΜεταπτυχιακόΑπαιτούμενη Προϋπηρεσία - ΑδιάφοροΚατηγορίες - Επαγγέλματα Υγείας, Έρευνας & Ανάπτυξης, Επιστήμες

Περιγραφή

PHARMINNOVA P.C. is an experienced, consulting Company, focused on the global pharmaceutical industry, covering services for an extensive portfolio of medicinal products. The aim of PHARMINNOVA is to provide our customers with a reliable, flexible and effective strategic, regulatory and scientific affairs service, covering all stages of pharmaceutical development and authorisation process in a timely and cost-effective manner. Our mission is to assist pharmaceutical companies in rationalizing drug development and we use innovative approaches and services, in order to translate the scientific knowledge into tangible benefits for patient care.

PHARMINNOVA is currently recruiting to expand the Scientific Affairs team. The ideal candidate will participate as a member of the team and contribute under the wider scope of providing scientific and regulatory advice services to Pharma Industry clients.
 
Basic Role and Responsibilities
• Scientific literature search and review related to the non-clinical and clinical aspects of pharmaceutical products
• Preparation of non-clinical and clinical expert documents to be included in submission dossiers according to EMA scientific guidelines and EU regulatory framework
• Contribution to the preparation of response to deficiency letters, strategic and scientific advice documents and scientific assessments related to non-clinical and clinical issues
• Participation in meetings with clients and health authorities 
• Co-ordination of research and development projects 

Experience & Qualification
• University degree in Pharmacy or Biology
• Education to an M.Sc. level in Pharmacology, Biopharmaceutics/Pharmacokinetics, Clinical Pharmacy, Biostatistics or similar scientific disciplines
• Basic knowledge of EU regulatory environment, CTD Dossier format and EMA clinical efficacy and safety guidelines would be an advantage
• Excellent English oral and written communication and basic scientific writing skills
• PC literacy, excellent knowledge of MS® Office tools
• Ability to work to tight deadlines and multi-task, as an individual as well as a member of a team.

Pharminnova P.C.  Offers
• Competitive salary based on Industry standards and depending on qualifications and experience
• Training opportunities 
• Challenging working environment

Περιγραφή Εταιρίας