[Remote] FSP Principal Medical Writer at Thermo Fisher Scientific

North Carolina, United States

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
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 an advanced degree preferred. A minimum of 12 years of relevant experience is required, including experience managing and directing complex medical writing projects. Experience in the pharmaceutical/CRO industry and with submission documents is advantageous, as are additional qualifications in medical writing. Expert knowledge of global, regional, national, and other document development guidelines, as well as expertise in one or more specialty areas, is essential.

Responsibilities

The Associate Medical Writing Director will lead multiple large, complex, strategic client programs, often requiring significant client engagement. This role involves reviewing documents, providing training and guidance to junior team members, and acting as a subject matter expert to advise on document development strategy, regulations, and industry best practices. Responsibilities include writing complex documents, providing senior review, overseeing the work of other medical writers and program managers, ensuring compliance with quality processes, and leading process improvement initiatives. The role also involves partnering with business development and senior management to secure new business, including making client presentations and supporting contract negotiations.

Skills

Medical Writing
Clinical Trials
Oncology
Regulatory Submissions
Document Development
Project Management
Client Management
Team Leadership
Communication

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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