[Remote] Associate Medical Director/Medical Director - Cardiology at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

NoVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Medical expertise in Cardiology (implied by job title and responsibilities)

Responsibilities

Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed
Attends and presents at investigator and sponsor meetings
Provides medical consultation to clients, investigators, and project team members
Supports business development activities
Provides medical review and analysis for clinical trial serious adverse events, marketed products 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, CSR)
Ensures tasks delegated to PVG are properly executed and adheres to applicable regulations, ICH guidelines, client SOPs/directives, project-specific WPDs, and PPD’s corporate policies/SOPs/WPDs
Provides medical consultation to team members and answers all study-related medical questions
Communicates clearly with associates and clients to ensure all procedures are followed appropriately
Provides therapeutic training and protocol training on assigned studies, as requested
Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure medical content is accurate and complete
Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies
Discusses all medical concerns with principal investigators and clients (e.g., discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in interpretation and decision-making
Provides medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites
Performs data review as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess for potential safety concerns
Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, and supports dossier maintenance for marketed products

Skills

Key technologies and capabilities for this role

PharmacovigilanceClinical TrialsMedical OversightSerious Adverse EventsICSRPBRERPSURDSURGCPRegulatory ReportingMedical ReviewSafety MonitoringInvestigator MeetingsBusiness Development

Questions & Answers

Common questions about this position

Is this position remote?

Yes, the position is remote based in the U.S. or Canada.

What is the salary range for this role?

This information is not specified in the job description.

What are the key responsibilities of this role?

The role involves providing medical oversight of clinical trials, reviewing serious adverse events and safety reports, attending investigator meetings, and offering medical consultation to teams and clients.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work with positive global impact, enabling career goals through resources and collaboration to solve tough challenges like environmental protection and finding cures for cancer.

What are the application requirements?

Candidates must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check including drug screening.

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.

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