ICF Principal Medical Writer (FSP) 

North Carolina, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates must possess a Bachelor's degree in a scientific discipline or equivalent, with a preference for Life Sciences. A minimum of 4 years of experience in the pharmaceutical industry and/or clinical research organization, including 2 years in study start-up and ICF development, is required. Knowledge of global regulatory and compliance requirements for clinical research, such as US CFR, EU CTD, and ICH GCP, is essential. Experience with Structured Content Authoring systems and automation, Veeva, and a clinical background as an RN are preferred. Excellent organizational and program management skills, proven ICF authoring and management skills, and extensive knowledge of regulatory guidelines and drug development processes are necessary.

Responsibilities

The Principal Medical Writer will be responsible for the end-to-end development and management of Master Informed Consent Forms (ICFs) for clinical trials, driving process improvements to enhance quality, reduce turnaround time, and ensure compliance. This includes providing subject matter expertise, coordinating ICF kick-off meetings, preparing Master ICFs, supporting country and site-specific reviews, managing amendments, and ensuring stakeholder reviews are completed. The role also involves supporting updates to language libraries, reviewing protocols, supporting process improvement initiatives through training development, serving as a subject matter expert for ICF processes, and assisting with audit findings and CAPAs. During periods of reduced ICF workload, support may be provided for other study-related activities such as TMF review and drafting study plans.

Skills

Medical Writing

Informed Consent Forms (ICFs)

Clinical Trials

Structured Content Authoring

Regulatory Compliance

Project Management

Stakeholder Collaboration

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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