Submissions/Sr Submissions Specialist, Denmark – Pharmaceutical Product Development (PPD) – Copenhagen

We have a new opening for theposition of Senior/Submssions Specialist (internally called: Country / Senior Country Approval Specialist) in our Start Up (SIA) team based at our Copenhagen office 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 Denmarkas 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 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

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 packages

We have a new opening for theposition of Senior/Submssions Specialist (internally called: Country / Senior Country Approval Specialist) in our Start Up (SIA) team based at our Copenhagen office 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 Denmarkas 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 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

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 packages

Qualifications and experience University degree in a health/science-related field will be an advantage or certified health care training or equivalent experience Demonstrated experience in start-up activities (EC and CA submission management; ICF customization; Biobank submission; Radiation Committee submission) Deep knowledge in EU and Danish regulations Understanding of ICH GCP Strong attention to detail Customer focus Effective communication and interpersonal skills Good organizational and time management skills Ability to work in a team or independently as required Fluency in Danish and English, both written and spoken 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.

#LI-MC2

#LI-Remote

Qualifications and experience University degree in a health/science-related field will be an advantage or certified health care training or equivalent experience Demonstrated experience in start-up activities (EC and CA submission management; ICF customization; Biobank submission; Radiation Committee submission) Deep knowledge in EU and Danish regulations Understanding of ICH GCP Strong attention to detail Customer focus Effective communication and interpersonal skills Good organizational and time management skills Ability to work in a team or independently as required Fluency in Danish and English, both written and spoken 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.

#LI-MC2

#LI-Remote

2021-01-29 00:00:00

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