Country Approval Specialist - FSP

Thermo Fisher Scientific GmbH; Deutschland; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

IT-Systemhaus der Bundesagentur für Arbeit is seeking a Country Approval Specialist to lead local regulatory submissions and coordinate with global strategy. You will join a team responsible for MoH and EC dossiers, ensuring timely and compliant country submissions across sites.

You will advise internal clients on local regulatory strategy, manage SIA projects, liaise with investigators, prepare patient information sheets as needed, and maintain trial status and filing per SOPs within an

Qualifikationen

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 2+ years of regulatory submission experience or equivalent.
• Equivalency may be considered with education, training and/or related experience.

Aufgaben

• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional local applications) in alignment with global submission strategy.
• Provides local regulatory strategy advice (MoH/EC) to internal clients.
• Provides project-specific local SIA services and coordination.
• May contact investigators for submission activities.
• Key-contact at country level for submission-related activities.
• Coordinates with internal departments to align site start-up activities with submission timelines.
• Achieves target cycle times for site activation.
• May assist with regulatory review packages and patient information sheets.
• May help with grant budgets and site payments negotiations.
• Supports feasibility activities within agreed timelines.
• Maintains trial status information in PPD tracking databases.
• Ensures local study files and filing meet SOPs.
• Keeps knowledge up-to-date with regulatory guidelines.

Kenntnisse

Communication skills

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English proficiency

Medical terminology

Teamwork/independence

Organizational skills

Regulatory guidelines knowledge

Ausbildung

Bachelor's degree or equivalent

Jobbeschreibung

Country Approval Specialist - FSP

Beginn

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

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 team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy.

What You’ll Do

• 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 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
• 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

Working Conditions and Environment

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves