20 Beste vacatures voor de functie van writer (nieuwe medewerkers gezocht)

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Principal Medical Writer - FSP
IQVIA —Amsterdam
- Fulltime
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- Onderzoek
9 dagen
Technical Writer
Global Factories —Den Haag
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LiveTicketGroup —Amsterdam Zuid
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EMVI Schrijver/ Bid Writer
Exactpi —Utrecht
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- Winstdeling
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Technical Writer
Highlite International —Kerkrade
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TicketSwap —Amsterdam
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Junior/ Medior Content Creator
Priva —De Lier
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Monumental —Amsterdam
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Commify —Amsterdam
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Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands, Spain
サイネオス・ヘルス —Amsterdam
- Microsoft Word
- Projectmanagement
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1 dag
Freelance — Senior Art Director
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JINGDONG RETAIL (UK) LIMITED —Rotterdam
- Engels
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Technical Writer Medical Devices and Combination Products
Kuros Biosciences —Bilthoven
- Fulltime
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Technisch Auteur - Technical Writer
Spring Engineering —Zuid-Holland
- E-mail
- Engineering
- Engels
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Software Engineering Consultant Amsterdam
Software Improvement Group —Amsterdam Zuid
- € 3.800 - € 4.000 per maand
- Engels
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- Analytisch vermogen
Snel solliciteren
10 dagen
Visual Designer (Private Label) Internship
Picnic —Amsterdam
- € 800 per maand
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- Engels
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Snel solliciteren
Project Manager Product Development
Lely —Maassluis
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- Hybride werken
- Engels
- Master
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- Flexibele werkuren
Snel solliciteren

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Principal Medical Writer - FSP

IQVIA -
Amsterdam

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Vacaturegegevens

Fulltime
9 dagen geleden

Kwalificaties

Microsoft Word
Doctor
Onderzoek
Master
Projectmanagement
Bachelor
Farmacie
Documentmanagementsystemen
Communicatieve vaardigheden
Tijdmanagement

Volledige vacaturetekst

Amsterdam, Netherlands | Full time | Home-based | R1523797

Overview

We are seeking an experienced Senior Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and marketing authorization applications (MAAs/NDAs/BLAs) are scientifically accurate, consistent, and aligned with program objectives and global regulatory requirements.

The successful candidate will act as a lead writer for key summary documents, providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the Director of Medical Writing (or above)

Key Responsibilities

Lead the development of high-quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, and marketing authorization submissions) in compliance with global regulatory guidelines (ICH, FDA, EMA) and internal standards
Serve as the lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs
Provide strategic guidance to cross-functional teams on document content, messaging, and regulatory positioning to ensure alignment with program goals
Manage medical writing projects, including planning, timelines, resource coordination, and delivery to ensure milestones and submission deadlines are met
Collaborate with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety, etc.) to gather, interpret, and accurately present clinical data
Mentor and support other medical writers, ensuring high-quality, scientifically sound, and consistent deliverables across projects
Review and edit project-related documents to ensure accuracy, clarity, consistency, and compliance with templates and style guides
Attend project and team meetings to provide expert input on document development, study data interpretation, and process improvements
Contribute to and lead process improvement initiatives to enhance efficiency, quality, and consistency in document preparation
Develop, maintain, and refine standard operating procedures (SOPs), templates, and best practices for medical writing
Stay current with evolving global regulatory requirements, industry trends, and therapeutic area knowledge to ensure compliance and innovation

Qualifications

Bachelor’s degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
Minimum of 5+ years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered
Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements
Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams
Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed
High attention to detail with a commitment to quality, consistency, and scientific accuracy
Proficiency in Microsoft Word and document formatting best practices
Experience with electronic document management systems (eDMS) and familiarity with document templates, style guides, and structured authoring tools

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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writer vacatures

Principal Medical Writer - FSP

Technical Writer

SEO Specialist

EMVI Schrijver/ Bid Writer

Technical Writer

Product Designer Buyer Activation

Junior/ Medior Content Creator

Exec Ops/Special Projects

Director of Meetings & Special Events (The St. Regis Aruba Resort)

Mid-Level Finance Officer

Senior Brand Designer

Customer Success Internship

Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands, Spain

Freelance — Senior Art Director

UX Designer

Technical Writer Medical Devices and Combination Products

Technisch Auteur - Technical Writer

Software Engineering Consultant Amsterdam

Visual Designer (Private Label) Internship

Project Manager Product Development

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van writer

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