Submission Specialist Regulatory Officer
شارك هذه الوظيفة
موقع الوظيفة:
الراتب شهرياً:
تاريخ النشر:
أمس
عدد الوظائف الشاغرة:
1 عدد الوظائف الشاغرة
ملخص الوظيفة
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.
Office-based 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 regulatory-related 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
Detail-oriented
Ability to learn plan and work in a dynamic team environment
Communication collaboration and problem-solving skills
*Please send your CV in English
Additional Information :
We offer:
- Excellent working conditions
- Extensive training and friendly team
- Competitive salary and benefits package
- Opportunities for personal and professional growth
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
Remote Work :
No
Employment Type :
Full-time
المهارات المطلوبة
- محامي الرعاية الصحية
- الأمن السيبراني
- أساسي
- العمليات القانونية
- خدمة التدبير المنزلي
عن الشركة
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... اعرض المزيد
