Ctry Approval Spec - Korea

Pharmaceutical Product Development (PPD)

KR-Seoul-Seoul KR Yeoksamdong


PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times. Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.

As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

Responsibilities: 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 strategyProvides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clientsProvides project specific local SIA services and coordination of these projectsMay have contact with investigators for submission related activitiesKey-contact at country level for either Ethical or Regulatory submission-related activitiesCoordinates, 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 activationAchieves PPD’s target cycle times for siteMay work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicableMay develop country specific Patient Information Sheet/Informed Consent form documentsMay assist with grant budgets(s) and payment schedules negotiations with sitesSupports the coordination of feasibility activities, as required, in accordance with agreed timelinesEntes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely mannerEnsures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPsMaintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Grow your career as a Senior Country Approval Specialist, a Feasibility Specialist, or a Site Contract Specialist - all supporting site activation. You could move into the country management career track, managing a country or groups of countries for site activation. Or, pursue other paths within our Global Clinical Development group. These are just a few career pathways available once you chose to Be with PPD.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect NextWe look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times. Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.

As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

Responsibilities: 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 strategyProvides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clientsProvides project specific local SIA services and coordination of these projectsMay have contact with investigators for submission related activitiesKey-contact at country level for either Ethical or Regulatory submission-related activitiesCoordinates, 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 activationAchieves PPD’s target cycle times for siteMay work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicableMay develop country specific Patient Information Sheet/Informed Consent form documentsMay assist with grant budgets(s) and payment schedules negotiations with sitesSupports the coordination of feasibility activities, as required, in accordance with agreed timelinesEntes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely mannerEnsures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPsMaintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Grow your career as a Senior Country Approval Specialist, a Feasibility Specialist, or a Site Contract Specialist - all supporting site activation. You could move into the country management career track, managing a country or groups of countries for site activation. Or, pursue other paths within our Global Clinical Development group. These are just a few career pathways available once you chose to Be with PPD.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect NextWe look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

Qualifications

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years)Knowledge, Skills, and Abilities:Effective oral and written communication skillsExcellent interpersonal skillsStrong attention to detail and quality of documentationGood negotiation skillsGood computer skills and the ability to learn appropriate softwareGood English language and grammar skillsBasic medical/therapeutic area and medical terminology knowledgeAbility to work in a team environment or independently, under direction, as requiredBasic organizational and planning skillsBasic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and

Qualifications

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years)Knowledge, Skills, and Abilities:Effective oral and written communication skillsExcellent interpersonal skillsStrong attention to detail and quality of documentationGood negotiation skillsGood computer skills and the ability to learn appropriate softwareGood English language and grammar skillsBasic medical/therapeutic area and medical terminology knowledgeAbility to work in a team environment or independently, under direction, as requiredBasic organizational and planning skillsBasic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and


2020-06-24 00:00:00


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