Principal Medical Writer- Client Embedded

Maryland, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Candidates must possess a Bachelor's degree in a scientific discipline or equivalent, with an advanced degree preferred. A minimum of 8 years of regulatory writing experience in the pharmaceutical/CRO industry is required, including experience managing complex medical writing projects and extensive experience in Phase 3 CSRs and/or protocol development. EU CTR experience and familiarity with structured content management systems, AI-driven content creation, and Natural Language Generation are preferred. Excellent organizational, program management, and leadership skills are essential, along with extensive knowledge of regulatory guidelines and drug development processes.

Responsibilities

The Principal Medical Writer will lead the development, writing, and editing of complex clinical and regulatory documents, ensuring accuracy and timeliness. Responsibilities include collaborating with cross-functional teams, ensuring documents align with regulatory guidelines and company standards, and providing strategic input on document content and structure. The role also involves mentoring junior medical writers, managing multiple projects, and staying current with industry trends and regulatory requirements.

Skills

Medical Writing

Clinical Regulatory Documents

Structured Content Authoring

Automation

Biotechnology

Autoimmune Diseases

Scientific Writing

Regulatory Writing

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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