Ctry Approval Associate (Warsaw, Poland)

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. 

As a Country Approval Associate, you will be responsible for assisting for regulatory Country Submissions together in order to activate investigative sites.

Essential Functions: Performs all administrative tasks in order to 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 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 provide

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. 

As a Country Approval Associate, you will be responsible for assisting for regulatory Country Submissions together in order to activate investigative sites.

Essential Functions: Performs all administrative tasks in order to 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 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 provide

Education and Experience:

Bachelor's degree in life-science field

At least 1 year experience in start-up activities

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

What we offer

At PPD we hire the best, develop ourselves and each other, and recognise 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 programme, 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 organisation but with a local feel.

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. 

Education and Experience:

Bachelor's degree in life-science field

At least 1 year experience in start-up activities

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

What we offer

At PPD we hire the best, develop ourselves and each other, and recognise 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 programme, 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 organisation but with a local feel.

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.