Top 2272 Language specialist Jobs in 'remote

Country Approval Specialist - FSP
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- English
- Mid-level
- Office
Remote Editorial Content Specialist
Turing —Remote
- $100 - $150 an hour
- Contract
- Remote
- English
- Mid-level
- Master's degree
Quick Apply
2d
Literacy Specialist
Wilson Language Training —Remote
- $73,700 - $100,000 a year
- Full-time
- Remote
- Mid-level
- Presentation skills
- Travel
- Paid holidays
- Disability insurance
Literature Specialist – Freelance AI Trainer Project
Meridial —Remote
- $6 - $65 an hour
- Remote
- Analysis skills
- Teaching
- Entry level
- Health insurance
Partner Education Specialist
Ellevation —Remote
- $70,000 - $80,000 a year
- Full-time
- Remote
- School experience
- Up to 50% travel
- Mid-level
- Paid holidays
- Health insurance
Psychology Specialist - Freelance AI Trainer Project
Meridial —Remote
- $8 - $65 an hour
- Remote
- Mid-level
- Bachelor's degree
- Psychology
- Health insurance
Travel Specialists - Worldwide
Datavio.ai —Remote
- Part-time
- Writing skills
- Communication skills
- Entry level
Healthcare Compliance Specialist- Remote
CHP Health —Remote
- $130,000 - $190,000 a year
- Remote
- Continuous improvement
- Senior level
- 4 years
- Continuing education credits
- Paid holidays
Quick Apply
Scheduling Implementation Specialist
Empeon —Remote
- $75,000 - $100,000 a year
- Call employer
- Remote
- Skilled nursing facility
- Mid-level
- Presentation skills
Quick Apply
Sports Specialist - Freelance AI Trainer Project
Meridial —Remote
- $8 - $65 an hour
- Remote
- Mid-level
- Analysis skills
- Communication skills
- Health insurance
Customer Success Specialist
LighthouseAI, a Pharma Solutions Company —Remote
- $70,000 - $80,000 a year
- Full-time
- Remote
- Microsoft Excel
- Computer literacy
- Writing skills
- Paid holidays
- Disability insurance
Quick Apply
Technical Support Specialist
Yello —Remote
- $65,000 - $85,000 a year
- Mid-level
- 3 years
- Analysis skills
Training and Development Specialist - Freelance AI Trainer Project
Meridial —Remote
- $8 - $65 an hour
- Remote
- Mid-level
- Education
Employee Relations Intake Coordinator
MedStar Health —Remote
- $31.28 - $56.39 an hour
- Full-time
- Remote
- Computer literacy
- Mid-level
- Bachelor's degree
4d
Amazon Compliance Specialist
Kitsch LLC —Remote
- Full-time
- Remote
- Mid-level
- 3 years
- Training & development
Patient Support Specialist (9:30am -6pm PST)
Zócalo Health —Remote
- $26 - $28 an hour
- Full-time
- Remote
- Spanish
- HIPAA
- English
- Health insurance
- Dental insurance
Medical Content Specialist (Contract)
Everlywell —Remote
- $45 - $55 an hour
- Part-time
- Remote
- Clinic experience
- Mid-level
- 3 years
Professional Learning Specialist, Northeastern US
IXL Learning —Remote
- Full-time
- School experience
- 5 years
- Bachelor of Science
Payroll specialist
Intone Networks —Remote
- Contract
- Customer service
- Mid-level
- Administrative experience
English Language Evaluation Specialist
AuraOne Human Data —Remote
- Remote
- Writing skills
- Mid-level
- US work authorization

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Country Approval Specialist - FSP

Thermo Fisher Scientific -
North Carolina

Apply Now

Job Details

Full-time

Qualifications

FDA submissions
Critical path method
Informed consent
Document control experience within pharmaceutical industry
Drug regulation
English
Mid-level
Clinical research protocol review
Bachelor's degree
Quality control
Informed consent procedures implementation
Clinical trial standard operating procedures
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Computer skills
Clinical trial site selection
Clinical consent forms
Ethical review application preparation
Grammar Experience
Standard operating procedures (SOPs)
Medical terminology
Communication skills
Negotiation

Full Job Description

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 biotech's, 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 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.

What You’ll Do:

Prepare, review, and coordinate local regulatory submissions (EC, additional special national local applications if applicable, e.g. therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy for the initial application and amendments as necessary.
Provide local regulatory strategy advice (RA &/or EC) to key stakeholders.
Provide local submission strategy for their country in consultation with regional oversight lead and key team members.
Provide technical expertise and coordination oversight for study in collaboration with relevant stakeholders.
Serve as primary contact for investigators and with the local regulatory authorities and ethics committees (in collaboration with their People Manager for complex issues) to ensure submissions are managed in a timely manner.
Serve as a key contact at the country level for submission-related activities and ensure guidelines and processes are followed for effective communications with study teams, investigators, and RAs and ECs to ensure submissions are managed in a timely manner.
May identify issues or anomalies in the regulatory process of a study and escalate as appropriate.
May support country specific Informed Consent Form (ICF) negotiations with EC/IRB or RA and raise any country-level ICF risks to Informed Consent Manager (ICM) and study leadership.
Develop site-specific ICFs manage ICF negotiations with EC/IRB, and document site ICF approvals.
Adapt country and site specific ICF changes for protocol and Investigator Brochure (IB) amendments as necessary.
Coordinate with key stakeholders 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.
Align with the site on the critical start-up path upon site selection and take accountability for maintaining accurate tracking of the site’s critical path throughout the start-up phase.
Achieve set baseline cycle times for site activation.
Responsible for Essential Documents (ED) creation, collection and QC.
May prepare Essential Document Packs (EDPs).
If required for the study, support the coordination of feasibility activities, in accordance with agreed timelines.
Ensure that trial status information relating to start-up activities is accurately maintained in the database and is always current.
Ensure current investigator and site staff contact details are appropriately maintained in systems.
Ensure TMF is current for country and sites according to sponsor SOPs.
Maintains knowledge of and understand PPD SOPs, sponsor SOPs/directives, and current regulatory guidelines as applicable to services provided.
Complete handover document and provide to Site Manager at the appropriate point – which will be study dependent.
Participate as required in Team Meetings.
May be required to support activation readiness at the site level to ensure training completion, system access, and supplies are onsite.

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.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

Apply Now

Refine Your Search

language specialist jobs in 'remote

Country Approval Specialist - FSP

Remote Editorial Content Specialist

Literacy Specialist

Literature Specialist – Freelance AI Trainer Project

Partner Education Specialist

Psychology Specialist - Freelance AI Trainer Project

Travel Specialists - Worldwide

Healthcare Compliance Specialist- Remote

Scheduling Implementation Specialist

Sports Specialist - Freelance AI Trainer Project

Customer Success Specialist

Technical Support Specialist

Training and Development Specialist - Freelance AI Trainer Project

Employee Relations Intake Coordinator

Amazon Compliance Specialist

Patient Support Specialist (9:30am -6pm PST)

Medical Content Specialist (Contract)

Professional Learning Specialist, Northeastern US

Payroll specialist

English Language Evaluation Specialist

I want to receive the latest job alert for language specialist in 'remote

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