Country Approval Spec - 1 year FTC
Pharmaceutical Product Development (PPD)
Lisbon PT Av da Liberdade, Lisbon, PT
há 2 dias

Country Approval Specialist (Submissions Specialist) -Lisbon

PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people.

We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

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.

PPD are currently hiring for an experienced Country Approval Specialist to join our team in Portugal, working from our Johannesburg office.

As a Country Approval Specialist, you will be responsible for :

Prepar ing , review ing and coordinat ing local regulatory submissions ( MoH , EC, additional special national local applications if applicable ) Provid ing local regulatory strategy advice ( MoH & / or EC) to internal clients Develop ing and implementing local submission strategy Provid ing technical expertise and coordination oversight for projects Acting as the primary contact for investigators and with the local regulatory authorities to ensure submissions are managed in a timely manner Act ing as a key-contact at country level for all submission-related activities Achiev ing PPD’s target cycle times for site activations Prepar ing the regulatory compliance review packages Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy Developing country specific Patient Information Sheet / Informed Consent form documents Support ing the coordination of feasibility activities, as required, in accordance with agreed timelines.

Ensur ing that trial status information relating to SIA activities are accurately maintained Oversee ing country study files and ensures that that they meet PPD WPDs or client SOPs

Country Approval Specialist (Submissions Specialist) -Lisbon

PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people.

We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

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.

PPD are currently hiring for an experienced Country Approval Specialist to join our team in Portugal, working from our Johannesburg office.

As a Country Approval Specialist, you will be responsible for :

Prepar ing , review ing and coordinat ing local regulatory submissions ( MoH , EC, additional special national local applications if applicable ) Provid ing local regulatory strategy advice ( MoH & / or EC) to internal clients Develop ing and implementing local submission strategy Provid ing technical expertise and coordination oversight for projects Acting as the primary contact for investigators and with the local regulatory authorities to ensure submissions are managed in a timely manner Act ing as a key-contact at country level for all submission-related activities Achiev ing PPD’s target cycle times for site activations Prepar ing the regulatory compliance review packages Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy Developing country specific Patient Information Sheet / Informed Consent form documents Support ing the coordination of feasibility activities, as required, in accordance with agreed timelines.

Ensur ing that trial status information relating to SIA activities are accurately maintained Oversee ing country study files and ensures that that they meet PPD WPDs or client SOPs

Requirements B achelor's degree in Life Science related discipline Pr evious experience that provides the knowledge, skills, and abilities to perform the job - CRA experience will also be considered Knowledge of all applicable regional / national country regulatory guidelines and EC regulations Effective oral and written communication skills , including fluency in English Strong attention to detail and quality of documentation Good negotiation and interpersonal skills G ood computer skills and the ability to learn appropriate software Good judgment and decision-making skill s Basic medical / therapeutic area and medical terminology knowledge Ability to work in a team environment or independently, with minimal supervision, as required

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.

  • 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 only short-listed candidates will be contacted.

  • LI-MP1
  • Requirements B achelor's degree in Life Science related discipline Pr evious experience that provides the knowledge, skills, and abilities to perform the job - CRA experience will also be considered Knowledge of all applicable regional / national country regulatory guidelines and EC regulations Effective oral and written communication skills , including fluency in English Strong attention to detail and quality of documentation Good negotiation and interpersonal skills G ood computer skills and the ability to learn appropriate software Good judgment and decision-making skill s Basic medical / therapeutic area and medical terminology knowledge Ability to work in a team environment or independently, with minimal supervision, as required

    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.

  • 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 only short-listed candidates will be contacted.

  • LI-MP1
  • 2020-06-05 00 : 00 : 00

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