Country Approval Specialist - Beijing, Shanghai, Homebased

Submission for the position: Country Approval Specialist - Beijing, Shanghai, Homebased - (Job Number: 150394)PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading U.S. based CRO and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company. Since opening in 2007, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You’ll have the opportunity to work on multinational trials—with top-tier sponsors, and on an industry-leading platform. This is a great time to join PPD China. Currently PPD is recruiting for Country Approval Specialist to join our Site Intelligence & Activation (SIA) department. Our goal-driven teams combine and deliver study start-up activities for clinical trials in China, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease start-up timelines and exceed expectations. Essential Functions and Other Job Information: Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. Provides project specific local SIA services and coordination of these projects. May have contact with investigators for submission related activities. Key-contact at country level for either Ethical or Regulatory submission-related activities. Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. Achieves PPD's target cycle times for site. May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. May develop country specific Patient Information Sheet/Informed Consent form documents. May assist with grant budgets(s) and payment schedules negotiations with sites. Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner. Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading U.S. based CRO and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company. Since opening in 2007, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You’ll have the opportunity to work on multinational trials—with top-tier sponsors, and on an industry-leading platform. This is a great time to join PPD China. Currently PPD is recruiting for Country Approval Specialist to join our Site Intelligence & Activation (SIA) department. Our goal-driven teams combine and deliver study start-up activities for clinical trials in China, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease start-up timelines and exceed expectations. Essential Functions and Other Job Information: Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. Provides project specific local SIA services and coordination of these projects. May have contact with investigators for submission related activities. Key-contact at country level for either Ethical or Regulatory submission-related activities. Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. Achieves PPD's target cycle times for site. May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. May develop country specific Patient Information Sheet/Informed Consent form documents. May assist with grant budgets(s) and payment schedules negotiations with sites. Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner. Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. Education and Experience: Bachelor's degree or above Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years') or equivalent combination of education, training, & experience. Knowledge, Skills and Abilities: Effective oral and written communication skills Excellent interpersonal 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 Basic medical/therapeutic area and medical terminology knowledge Ability to work in a team environment or independently, under direction as required Basic organizational and planning skills Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations Our offer:As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company.At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position. Locations we are hiring in are: Office based Beijing Office based Shanghai Home based China Education and Experience: Bachelor's degree or above Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years') or equivalent combination of education, training, & experience. Knowledge, Skills and Abilities: Effective oral and written communication skills Excellent interpersonal 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 Basic medical/therapeutic area and medical terminology knowledge Ability to work in a team environment or independently, under direction as required Basic organizational and planning skills Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations Our offer:As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company.At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position. Locations we are hiring in are: Office based Beijing Office based Shanghai Home based China Submission for the position: Country Approval Specialist - Beijing, Shanghai, Homebased - (Job Number: 150394)