FSP Country Approval Specialist

Location: Remote, Romania

Category: Clinical Research

Employment Type: Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Country Approval Specialist and 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, youll 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, youll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What you will do:

• Prepare, review and coordinate 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 EU/global submission strategy
• Provide local regulatory strategy advice (MoH &/or EC) to internal clients
• Provide project specific local start-up services and coordination of these projects
• May have contact with investigators for submission related activities
• Serve as key-contact at country level for either Ethical or Regulatory submission-related activities
• Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation
• Achieve target cycle times for site activation
• Prepare the regulatory compliance review packages, if applicable
• Develop country specific Patient Information Sheet/Informed Consent form documents
• May assist with grant budget(s) and payment schedules negotiations with sites
• May support the feasibility activities, as required, in accordance with agreed timelines
• Enter and maintain trial status information relating to start-up activities onto the study specific tracking databases in an accurate and timely manner
• Ensure the local country study files and filing processes are prepared, set up and maintained as per applicable SOPs
• Maintain knowledge of and understand SOPs, client directives, and current regulatory guidelines as applicable to services provided

Education and experience:

• Bachelors 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 environment
• Exposure to electrical office equipment