country ap proval specialistPPD

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:
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy
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.
To learn how PPD can advance your career, apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
Qualifications
Qualifications
Education and Experience:
Bachelor's degree in life science/healthcare-related courses (Nursing, Pharma, Med Tech, Bio, etc)
At least 2 years' experience in clinical trial site start-up/initiation activities and local regulatory submissions
Experience and knowledge in site feasibility and budget and contract negotiation is highly preferred
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 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 under pressure while prioritizing and
PPD

Taguig City, Metro Manila
Permanent
Full-time