Top 17 Biotechnology Jobs in Cullowhee, Nc

FSP Country Approval Specialist
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- Computer literacy
- English
- Mid-level
Lab Scientist
Stellar IT Solutions LLC —Hazelwood, NC
- $60 - $70 an hour
- Contract
- Ability to walk for extended periods
- Mid-level
- 3 years
Quick Apply
Special Agent: STEM—Physical Sciences Background
Federal Bureau of Investigation —United States
- $103,236 - $133,200 a year
- Full-time
- Mid-level
- Analysis skills
- Bachelor's degree
14d

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Medical Laboratory Scientist
Highlands-Cashiers Hospital —Highlands, NC
Required Education: Bachelor’s degree in Clinical Laboratory Science or related field from an accredited institution.
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Lab Technician 1
Pace Analytical Services —Asheville, NC
Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of…
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Lead Biotech Recruiter
Atrium —Westerville, OH
Join intake calls with hiring managers and department leads to understand recruitment needs, define job requirements and ensure alignment with candidate…
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CRA 1, IQVIA Biotech
IQVIA —Columbus, OH
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the…
$71,900 - $145,300 a year

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FSP Country Approval Specialist

Thermo Fisher Scientific -
North Carolina

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Job Details

Full-time

Qualifications

Computer literacy

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 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 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:

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).

Previous Contract Research Organization (CRO) experience is highly preferred.

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

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biotechnology jobs in cullowhee, nc

FSP Country Approval Specialist

Lab Scientist

Special Agent: STEM—Physical Sciences Background

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