Country approval associate / specialist I/II - fsp, customer-dedicated – At top tier biopharmaceutical, Czech Republic

Who is PPD?

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.


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.


Our FSP client

This role will be embedded within a client dedicated team. You will work alongside the clients own experienced personnel, as well as PPD colleagues to deliver leading edge clinical support.


Responsibilities:

• Prepare, review and coordinate, 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
• Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
• Provide project specific local SIA services and coordination of these projects
• Work directly and interact with investigator sites to complete critical information and readiness for site activation; inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, study contracts contacts, clinical supply shipment information, payment information, IRB submission and status
• 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
• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines
• Take the Lead and Coordinate the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
• Support the coordination of feasibility activities, as required, in accordance with agreed timelines
• Enter and maintain trial status information relating to SIA activities onto sponsor tracking databases in an accurate and timely manner
• Coordinate the timely communication, documentation and responses between Sponsor and Central Ethics committee to bring clinical study to approval (country dependent)
• Attend study Start-up meeting and provide functional updates on a country and site level
• 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

Education and Experience

• School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
• Relevant experience within a clinical trials environment and deep knowledge of clinical site activation (comparable with 2 to 5 years of experience, depending upon level)
• Experience working in the pharmaceutical industry/or CRO is an asset
• Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Must be fluent in Local language and in English.
• For individuals based in Canada: Bilingualism (French, English) is an asset
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Good technical skills and ability to learn and use multiple systems
• Experience working in a global environment
• Experience in working in more than 1 country is an asset


Knowledge, Skills and Abilities:

• Demonstrated knowledge and understanding of key operational elements of a clinical trial and processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain command of these processes
• Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach
• Proven ability to work independently and also as a team member
• Ability to organize tasks, time and priorities, ability to multi-task
• Understand basic medical terminology, GCP requirements and proficient in computer operations.
• Good computer skills and the ability to learn appropriate software

What we offer:

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development program, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Please note that due to the high volume of applications, only short-listed candidates will be contacted.


Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

What we offer:

o Learning and development programme, ensuring you reach your potential
o Extensive benefits package based around the health and well- being of our employees
o Competitive salary
o Flexible working culture with work- life balance
o Collaborative and friendly environment
o Global exposure and opportunity to work on international assignments


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 PPD
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.