FSP Country Approval Associate

Responsibilities

• Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy
• Support preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy
• Coordinate, under guidance, 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 company’s target cycle times for site
• May have contact with investigators for submission related activities
• May act as a key-contact at country level for either Ethical or Regulatory submission-related activities
• Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
• Assist in developing country specific Patient Information Sheet/Informed Consent form documents
• Assist with grant budgets(s) and payment schedules negotiations with sites
• Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) 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 PPD WPDs or applicable client SOPs
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Benefits

• Fully remote work
• A collaborative environment where development is part of the everyday experience
• Glassdoor
• 3.5
• Scientific technologies and biotech/pharmaceutical services.
• Waltham, Massachusetts, USA
• https://www.thermofisher.com
• Distribution of Different Job Fields Receiving Sponsorship
• Represents job field similar to this job
• Legal and Compliance
• Engineering and Development
• Management and Executive
• Product Management
• Accounting and Finance
• Marketing
• Sales
• Customer Service and Support
• Human Resources
• Arts and Entertainment
• Creatives and Design
• Trends of Total Sponsorships
• *2026
• (123)
• 2025
• (272)
• 2024
• (224)
• 2023
• (233)
• 2022

Qualifications

• 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 0 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
• 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
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

Required skills

• EC Regulations

Experience

• Entry level