Submission Specialist Regulatory Officer
صاحب العمل نشط
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكتروني
شارك هذه الوظيفة
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكتروني
الوصف الوظيفي
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products while taking a step further in your professional career.
Officebased role in Raanana Israel
You will:
Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities
Communicate with regulatory authorities ethics committees project teams and vendors on regulatoryrelated matters
Review translations of essential documents subject to clinical trial submission
Track the regulatory project documentation flow
Review documents to greenlight IP release to sites
Manage safety reporting to authorities
Deliver regulatory training to project teams
Assist with feasibility research and business development requests
Qualifications :
- College/University degree or an equivalent combination of education training and experience. Life science degree is a plus
Prior experience of at least one year with clinical trial submissions in Israel within the CRO or Pharmaceutical industries
Full working proficiency in English and Hebrew
Proficiency in MS Office applications and Matarot software
Detailoriented
Ability to learn plan and work in a dynamic team environment
Communication collaboration and problemsolving skills
*Please send your CV in English
Additional Information :
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people then PSI is the right choice for you.
Remote Work :
No
Employment Type :
Fulltime
نوع التوظيف
دوام كامل
