Country Approval Specialist

Thermo Fisher Scientific · Madrid

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Job Description

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions and local site activation in line with the global start up strategy. As a Country Approval Specialist, you'll play a key role in ensuring that site activations are managed effectively and align with our strategic goals.
What You’ll Do:

• Prepares, reviews and coordinates 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 local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provides project specific local SIA services and coordination of these projects.
• Contact investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.

• Coordinates 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.

• Leads local strategy and oversight of internal local team towards expedited site activation.
• Achieves PPD’s target cycle times for site.
• Work with the clinical team to prepare the regulatory compliance review packages, as applicable.
• Develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• 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 provided.

Education and Experience Requirements:

• 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).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:

• Effective oral and written communication skills
• Excellent interpersonal skills

• Excellent organizational and planning skills
• Strong attention to detail and quality of documentation

• Good prioritization skills

• Good leadership skills
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills

• Knowledge of all applicable regional / national country regulatory guidelines and EC regulations
• Basic medical/therapeutic area and medical terminology knowledge

• Ability to work in an evolving environment, flexibility and adaptability
• Ability to work in a team environment or independently, under direction, as required

Working Conditions and Environment:
• Work is performed in an office.

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