Country Approval Specialist, CZECH

PPD Czech Republic, s.r.o.

Place of work
Budějovická alej, Antala Staška, Praha 4, Czechia
Contract type
full-time
Wage (gross)
1 Kč/hourCompetitive

Information about the position

Job description, responsibilities and duties

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable. The Country Approval Specialist position is a fixed-term contract for 3 years.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

Responsibilities:

• Prepares, reviews and coordinates, 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
• Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
• Provides project specific local SIA services and coordination of these projects
• May have contact with investigators for submission related activities
• 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
• 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
• Entes 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 provided

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)

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

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.

Grow your career as a Senior Country Approval Specialist, a Feasibility Specialist, or a Site Contract Specialist - all supporting site activation. You could move into the country management career track, managing a country or groups of countries for site activation. Or, pursue other paths within our Global Clinical Development group. These are just a few career pathways available once you chose to Be with PPD.

To learn how PPD can advance your career, apply now!

What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

Employee perks, benefits

What we offer:
· Learning and development programme, ensuring you reach your potential
· Extensive benefits package based around the health and well- being of our employees
· Competitive salary
· Flexible working culture with work- life balance
· Collaborative and friendly environment
· 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.

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Language skills

English - Advanced (C1) and Czech - Advanced (C1)

Advertiser

Brief description of the company

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and approximately 27,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

Number of employees

1000 and more employees

Company address

PPD Czech, s.r.o.
140 00 Prague
http://www.ppdi.com

Contact

Kontaktní osoba: Maria Mazneva
E-mail: poslat životopis
ID: 4080771  Datum zveřejnění: 14.6.2021  Spodní hranice mzdy (brutto): 1 Kč/hour