Country Approval Specialist

JOB DESCRIPTION External - We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life‑saving therapies to patients. Our goal‑driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations. Summarized Purpose As a Country Approval Specialist, you are responsible for pulling regulatory country submissions together in order to activate investigative sites. You have strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable. Essential Functions 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 Enters 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 Qualifications Education and Experience : Bachelor's degree or equivalent and relevant formal academic/vocational qualification; previous experience comparable to 2+ years; equivalency of education, training or experience may be considered 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 Working Environment Communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner Work upright, stationary and/or standing for typical working hours Lifting and moving objects up to 25 pounds Work in non‑traditional work environments Use and learn standard office equipment and technology with proficiency Possibility of exposure to potentially hazardous elements typically found in healthcare or laboratory environments Work under pressure while prioritizing PPD Defining Principles We have a strong will to win — We earn our customer’s trust — We are gamechangers — We do the right thing — We are one #J-18808-Ljbffr