19 beste Stellen als medical science in offenbach – aktuell auf Personalsuche

Principal Medical Writer - FSP
IQVIA —Frankfurt am Main
- Vollzeit
- Microsoft Word
- Doktorat
- Forschungserfahrung
3 Tage
Scientist II - Physical Functional Testing
Smithers MDT —Frankfurt am Main
- Microsoft Word
- Microsoft Excel
- Textverarbeitung
Direkt bewerben
2 Tage
Associate Account Director, QualityMetric / Patient Centered Solutions (PCS)
IQVIA —Frankfurt am Main
- Vollzeit
- Vertrieb
- Bachelor
- Wirtschaft
Informatics Service Specialist
Waters Corporation —Eschborn
- Homeoffice
- Azure
- Oracle
- Informatik
Senior SAP Consultant (m/f/d)
Heraeus Holding GmbH —Hanau
- Vollzeit
- Kommunikationsfähigkeit
Senior Software Engineer - Trade Automation
Bloomberg —Frankfurt am Main
- Informatik
- Java
- C++
Global Product Manager Digital Products – Connectivity & Ecosystem Interoperability (m/f/d)
Fresenius Medical Care —Bad Homburg vor der Höhe
- Vollzeit
- Informatik
- Englisch
- Master
10 Tage
Director Market Access - Innovative products (m/f/d)
Viatris —Bad Homburg vor der Höhe
- Vollzeit
- Master
Senior Machine Learning Engineer - Medizinische KI-Entwicklung - Arbeitsgruppe Machine Learning
Universitätsmedizin Frankfurt —Frankfurt am Main
- Vollzeit
- Medizin
- Doktorat
- Informatik
Direkt bewerben
8 Tage
Senior Software Engineer - Market Oversight
Bloomberg —Frankfurt am Main
- Informatik
- Java
- C++
Technical Sales Manager (m/f/d)
Heraeus Holding GmbH —Hanau
- Vollzeit
- Vertrieb
- Englisch
- Projektmanagement
- Reisekostenerstattung
Sales Development Manager - Germany & Switzerland
Waters Corporation —Eschborn
- Microsoft Powerpoint
- Microsoft Excel
- Vertrieb
Business Development Manager
Smithers MDT —Frankfurt am Main
- Homeoffice
- Vertrieb
- Master
- Unternehmensentwicklung
Direkt bewerben
Head of Marketing (m/w/d)
Viatris —Bad Homburg vor der Höhe
- Vollzeit
- Vertrieb
- Englisch
- Master
Global Sales Manager Lamp (m/f/d)
Heraeus Holding GmbH —Kleinostheim
- Vollzeit
- Vertrieb
- Projektmanagement
(Senior) IT Consultant (m/f/d) Microsoft Cloud D365
Heraeus Holding GmbH —Hanau
- Überstunden
- Informatik
- Vertrieb
- Master
Dualer Student (m/w/d) Wirtschaftsinformatik E-Health
NEXUS AG —Frankfurt am Main
- Vertrieb
- Krankenhaus
- Hochschulreife
Senior Generative AI Engineer(M/W/D)
IQVIA —Frankfurt am Main
- Vollzeit
- Azure
- Informatik
- Master
Contracts Analyst
ICON Plc —Frankfurt am Main
- Vollzeit
- Forschungserfahrung
- Bachelor
- Mit Reiseanteil
1 Tag

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Scientist II - Physical Functional Testing
Smithers MDT —Frankfurt am Main
Conduct physical testing of medical devices and materials to generate high-quality scientific data. Physical testing experience involving materials or products.
Direkt bewerben
2 Tage

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Principal Medical Writer - FSP

IQVIA -
Frankfurt am Main

Jetzt bewerben

Details zur Stelle

Vollzeit
vor 3 Tagen

Qualifikationen

Microsoft Word
Doktorat
Forschungserfahrung
Master
Projektmanagement
Bachelor
Dokumentenmanagementsysteme
Zeitmanagement

Vollständige Stellenbeschreibung

Frankfurt am Main, Germany | 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.

Jetzt bewerben

Erweiterte Suche

medical science Jobs in offenbach

Principal Medical Writer - FSP

Scientist II - Physical Functional Testing

Associate Account Director, QualityMetric / Patient Centered Solutions (PCS)

Informatics Service Specialist

Senior SAP Consultant (m/f/d)

Senior Software Engineer - Trade Automation

Global Product Manager Digital Products – Connectivity & Ecosystem Interoperability (m/f/d)

Director Market Access - Innovative products (m/f/d)

Senior Machine Learning Engineer - Medizinische KI-Entwicklung - Arbeitsgruppe Machine Learning

Senior Software Engineer - Market Oversight

Technical Sales Manager (m/f/d)

Sales Development Manager - Germany & Switzerland

Business Development Manager

Head of Marketing (m/w/d)

Global Sales Manager Lamp (m/f/d)

(Senior) IT Consultant (m/f/d) Microsoft Cloud D365

Dualer Student (m/w/d) Wirtschaftsinformatik E-Health

Senior Generative AI Engineer(M/W/D)

Contracts Analyst

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