Dermatology at Thermo Fisher Scientific

North Carolina, United States

Apply Now

Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, including a drug screening

Responsibilities

Provide medical oversight of clinical trials to ensure SOPs, client directives, good clinical practice, and regulatory requirements are followed
Attend and present at investigator and sponsor meetings; provide medical consultation to clients, investigators, and project team members; support business development activities
Provide medical review and analysis for clinical trial serious adverse events, marketed product ICSR, and periodic safety reports (e.g., PBRER, PSUR, DSUR) as well as other client deliverables (e.g., labeling reconciliation documents, CTD modules, REMS, RMP, and CSR)
Ensure tasks delegated to PVG are properly executed; adhere to applicable regulations and ICH guidelines; follow client SOPs/directives and project-specific WPDs; comply with corporate policies and SOPs/WPDs
Provide medical consultation to team members and answer study-related medical questions; maintain clear communication with associates and clients
Provide therapeutic training and protocol training on assigned studies, as requested
Assist in writing/review of CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules to ensure medical content is accurate and complete
Clinical Trial Support: monitor safety variables (AEs, lab abnormalities, changes in patient status, concomitant medications; unblinding requests); discuss medical concerns with principal investigators and clients using proper medical judgment
Provide medical review of adverse events of special interest, SAEs, and clinical outcomes events; perform data review as per contract and data validation manual
Marketed Products Support: manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management

Skills

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

Land your dream remote job 3x faster with AI

Try Jobo Free