[Remote] FSP Medical Writer (EMEA) at Thermo Fisher Scientific

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Clinical ResearchIndustries

Requirements

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years of regulatory writing)
Experience working in the pharmaceutical/CRO industry preferred
Experience in scientific writing advantageous
Experience in the therapeutic areas of Immunology, Oncology or Vaccines advantageous
Solid medical writing skills, including grammatical, editorial, and proofreading skills
Ability to interpret and present complex data accurately and concisely
Effective administrative, organizational, and planning skills; attention to detail and quality
Ability to work on own initiative and effectively within a team
Effective oral and written communication skills
Good knowledge of regulatory documentation and drug development process
Great judgment and decision-making skills
Good computer skills and skilled with client templates; good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Responsibilities

Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies
May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
Ensures compliance with quality processes and requirements for assigned documents
May assist in determining best practices, methods, and techniques for achieving optimal results
May assist in program management activities, including assisting with developing timelines, budgets, forecasts for assigned deliverables
Represents the department at project launch meetings, review meetings, and project team meetings
Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients
Collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence

Skills

Medical Writing

Clinical Study Reports

Study Protocols

Investigator Brochures

INDs

MAAs

Immunology

Oncology

Vaccines

Scientific 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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