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Country Approval Specialist, Czech Republic or Slovakia
PPD Czech Republic, s.r.o.
Place of work
Budejovicka alej, Antala Staska 2027/79, 140 00 Praha 4, Slovak Republic, Prague
Budejovicka alej, Antala Staska 2027/79, 140 00 Praha 4, Slovak Republic, Prague
Contract type
full-time
full-time
Wage (gross)
Competitive
Competitive
Information about the position
Job description, responsibilities and duties
PPD is a leading global Contract Research Organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 18 000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit http://www.ppdi.com/.
Would you like to become part of a newly formed Site and Patient Access (SPA) group in PPD located either in Czech Republic or in Slovakia?
Then we have an opportunity for you - join our team of global professionals!
The Country Approval Specialist will manage the preparation, review and coordination of Ethics and Regulatory submission.
Main duties and Responsibilities include:
• Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy
• Provide, under guidance, local regulatory strategy advice to internal clients
• Provide project specific local submission service and coordination oversight for projects in collaboration with relevant internal departments
• Act as a key-contact at country level for all submission-related activities
• Coordinates, under guidance, with internal functional departments to ensure various study site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for study sites and study are aligned to the critical path for study site activation
• Prepare the regulatory compliance review packages with CRA, as applicable
• May develop country specific Patient Information Sheet/Informed Consent form documents
• May Support the coordination of feasibility activities, as required, in accordance with agreed timelines
• Ensures that trial status information relating to SPA activities are accurately maintained in the database and is current at all times.
• Oversees country study files and ensures that they meet PPD WPD's or client SOP's
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Would you like to become part of a newly formed Site and Patient Access (SPA) group in PPD located either in Czech Republic or in Slovakia?
Then we have an opportunity for you - join our team of global professionals!
The Country Approval Specialist will manage the preparation, review and coordination of Ethics and Regulatory submission.
Main duties and Responsibilities include:
• Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy
• Provide, under guidance, local regulatory strategy advice to internal clients
• Provide project specific local submission service and coordination oversight for projects in collaboration with relevant internal departments
• Act as a key-contact at country level for all submission-related activities
• Coordinates, under guidance, with internal functional departments to ensure various study site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for study sites and study are aligned to the critical path for study site activation
• Prepare the regulatory compliance review packages with CRA, as applicable
• May develop country specific Patient Information Sheet/Informed Consent form documents
• May Support the coordination of feasibility activities, as required, in accordance with agreed timelines
• Ensures that trial status information relating to SPA activities are accurately maintained in the database and is current at all times.
• Oversees country study files and ensures that they meet PPD WPD's or client SOP's
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Information about the selection process
HOW TO APPLY:
Please visit our internal corporate website go to Careers / Career Opportunities and select the appropriate location to find the job.
Please submit your CV in English.
This is an ongoing search. Suitable candidates will be contacted accordingly.
Please visit our internal corporate website go to Careers / Career Opportunities and select the appropriate location to find the job.
Please submit your CV in English.
This is an ongoing search. Suitable candidates will be contacted accordingly.
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
Personality requirements and skills
Requirements:
• Scientific degree, a higher qualification in a relevant subject and/or post-graduate courses in Regulatory Affairs would be an advantage
• 2 years related regulatory/ submission experience or equivalent combination of education, training & experience would be an advantage
• Effective oral and written communication skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills and native level in Czech and Slovak language
• Ability to work in a team environment or independently, with minimal supervision
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
• Scientific degree, a higher qualification in a relevant subject and/or post-graduate courses in Regulatory Affairs would be an advantage
• 2 years related regulatory/ submission experience or equivalent combination of education, training & experience would be an advantage
• Effective oral and written communication skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills and native level in Czech and Slovak language
• Ability to work in a team environment or independently, with minimal supervision
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
Advertiser
Brief description of the company
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Number of employees
1000 and more employees
ID: 3089300
Dátum zverejnenia: 1.6.2017
2017-06-01
lokalita: Budejovicka alej, Antala Staska 2027/79, 140 00 Praha 4, Slovak Republic, Prague Pozícia: Regulatory Affairs Specialist Spoločnosť: PPD Czech Republic, s.r.o.
Základná zložka mzdy (brutto) a ďalšie odmeny: Competitive