Sr Submission Specialist - fluent Finnish (Start Up Team) - Sweden

Submission for the position: Sr Submission Specialist - fluent Finnish (Start Up Team) - Sweden - (Job Number: 180283)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.

Site Intelligence and Activation (Start Up Team):

Our goal-driven teams combine and deliver start up 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 start up timelines and exceed expectations.

We have a new opening for a Senior Country Approval Specialist in our Start Up team based at our Stockholm office but supporting primarily our Finnish operations. This is a permanent, full-time position. We may consider a homebased location depending on experience.

As a CAS, you will manage the preparation, review and coordination of country submissions and start up activities in Sweden and Finland as part of international projects.

With a life sciences degree or nursing qualification and experience of Phase II to IV trials, you will have good knowledge of EU and local regulations and ICH GCP requirements.

A background as a Clinical Research Associate with previous experience in activities associated with the start-up of clinical trials would be an advantage.

Main duties and Responsibilities include:

Prepare, review and coordinate local Regulatory and Ethics Committee submissions in alignment with global submission strategy Provide local regulatory strategy and advice Act as a key contact on a country level for all submission related activities and provide oversight for projects in start up in Sweden and Finland Coordinate, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelines Prepare regulatory compliance review (Regulatory green light) packages

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.

Site Intelligence and Activation (Start Up Team):

Our goal-driven teams combine and deliver start up 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 start up timelines and exceed expectations.

We have a new opening for a Senior Country Approval Specialist in our Start Up team based at our Stockholm office but supporting primarily our Finnish operations. This is a permanent, full-time position. We may consider a homebased location depending on experience.

As a CAS, you will manage the preparation, review and coordination of country submissions and start up activities in Sweden and Finland as part of international projects.

With a life sciences degree or nursing qualification and experience of Phase II to IV trials, you will have good knowledge of EU and local regulations and ICH GCP requirements.

A background as a Clinical Research Associate with previous experience in activities associated with the start-up of clinical trials would be an advantage.

Main duties and Responsibilities include:

Prepare, review and coordinate local Regulatory and Ethics Committee submissions in alignment with global submission strategy Provide local regulatory strategy and advice Act as a key contact on a country level for all submission related activities and provide oversight for projects in start up in Sweden and Finland Coordinate, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelines Prepare regulatory compliance review (Regulatory green light) packages

Qualifications and experience

University degree in a health/science-related field or certified health care training or equivalent experience Demonstrated experience in start-up activities (EC and CA submission management; ICF customization) Deep knowledge in EU and Finnish regulations Understanding of ICH GCP Ability to work in a team or independently as required Fluent in Finnish, Swedish and English, both in written and spoken language Effective communication and interpersonal skills Strong attention to detail Customer focus

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - 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.

#LI-MC2

#LI-Remote

Qualifications and experience

University degree in a health/science-related field or certified health care training or equivalent experience Demonstrated experience in start-up activities (EC and CA submission management; ICF customization) Deep knowledge in EU and Finnish regulations Understanding of ICH GCP Ability to work in a team or independently as required Fluent in Finnish, Swedish and English, both in written and spoken language Effective communication and interpersonal skills Strong attention to detail Customer focus

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - 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.

#LI-MC2

#LI-Remote

Submission for the position: Sr Submission Specialist - fluent Finnish (Start Up Team) - Sweden - (Job Number: 180283)