Ctry Approval Spec

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
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**:

- 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
- 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.-
**What To Expect Next**Qualifications**

**Education and Experience**:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to2+ years)

**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
- 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 manner
- Able to work upright and stationary and/or standing for typical working hours
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments
- Able to use and learn standard office equipment and technology with proficiency
- May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments
- Able to perform successfully