Ctry Approval Spec

**JOB DESCRIPTION**:
Who is PPD Clinical Research Services?

PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers. PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine

The PPD FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

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
- 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**

**Job Qualification**:**
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 to 2+ 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

Our 4i values:

- Integrity - Innovation - Intensity - Involvement

Work Environment Requirements:
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:
PPD® FSP: People Who Deliver | PPD Careers - Read about PPD employee experiences
- LI-