Ctry Approval Assoc

The Country Approval Associate manages the preparation, review and coordination of Country Submissions in line with global submission strategy.Essential Functions and Responsibilities:Prepare, review and coordinate, under guidance, local EC submissions in alignment with global submission strategySupport preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategyMay coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensuresalignment of submission process for sites and study are aligned to the critical path for site activationAchieves PPD’s target cycle times for siteMay have contact with investigators for submission related activitiesMay act as a key-contact at country level for either Ethical or Regulatory submission-related activitiesWork with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicableMay assist in developing country specific Patient Information Sheet/Informed Consent form documentsMay assist with grant budgets(s) and payment schedules negotiations with sites.Enter and maintain trial status information relating to SIA activities onto PPD, or client (where contracted) tracking databases in an accurate and timely mannerEnsure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPsMaintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services providedThe Country Approval Associate manages the preparation, review and coordination of Country Submissions in line with global submission strategy.Essential Functions and Responsibilities:Prepare, review and coordinate, under guidance, local EC submissions in alignment with global submission strategySupport preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategyMay coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensuresalignment of submission process for sites and study are aligned to the critical path for site activationAchieves PPD’s target cycle times for siteMay have contact with investigators for submission related activitiesMay act as a key-contact at country level for either Ethical or Regulatory submission-related activitiesWork with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicableMay assist in developing country specific Patient Information Sheet/Informed Consent form documentsMay assist with grant budgets(s) and payment schedules negotiations with sites.Enter and maintain trial status information relating to SIA activities onto PPD, or client (where contracted) tracking databases in an accurate and timely mannerEnsure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPsMaintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services providedMinimum Required Education and Experience:High / Secondary school diplomaTypically requires a minimum of 4 years of related experienceRequired 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 regulationsPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.Minimum Required Education and Experience:High / Secondary school diplomaTypically requires a minimum of 4 years of related experienceRequired 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 regulationsPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.