PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.
Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-
changing therapies to improve health. The Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
Prepare, review and coordinate, under guidance, local EC submissions in alignment with global submission strategy
Support preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy
May coordinate, 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 have contact with investigators for submission related activities
May act as a key-contact at country level for either Ethical or Regulatory submission-related activities
Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
May assist in developing country specific Patient Information Sheet / Informed Consent form documents
May 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 manner
Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
Maintain knowledge of and understand PPD SOPs, Client SOPs / directives, and current regulatory guidelines as applicable to services provided* Bachelor's degree
Minimum of 2 years of related experience - EC / RA Submissions
Strong knowledge of national and international clinical trials legislation Required 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 Pharmaceutical 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.