[Remote] Principal Medical Writer at Thermo Fisher Scientific

France

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Life Sciences, PharmaceuticalsIndustries

Requirements

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years)
Experience in managing and directing complex medical writing projects required
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Significant knowledge of global, regional, national and other document development guidelines
In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Excellent project management skills
Advanced interpersonal, oral and written communication, and presentation skills
Excellent negotiation skills
Excellent judgment; high degree of independence in decision making and problem solving

Responsibilities

Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients
As the lead writer, reviews documents for the team and provides training and guidance to junior team members
Provides advice on document development strategy, regulations and industry best practices
Demonstrates subject matter and therapeutic area expertise
Acts as backup program manager
Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence
Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies
May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
Provides senior level review of routine and complex documents
Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge
Ensures compliance with quality processes and requirements for assigned documents
As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives
May also develop, review and manage performance metrics for assigned projects
May serve as backup program manager; identifies and resolves out-of-scope activities; duties could include developing timelines, budgets, forecasts and contract modifications, and assisting business development with client presentations and proposal text review, and attending bid defense meetings and capabilities presentations
Represents the department at project launch meetings, review meetings, and project team meetings

Skills

Medical Writing

Scientific Writing

Clinical Study Reports

Study Protocols

Investigator Brochures

INDs

MAAs

Regulatory Compliance

Document Review

Therapeutic Expertise

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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