10 Jobs für Regulatory Documentation Writer
Stellenangebote Regulatory Documentation Writer Jobs
Neu Job vor 4 Std. bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] Dossier Coordination Operations Closely collaborate with the GVAP Portfolio Lead to drive the development of JCA dossier strategy and final JCA dossier delivery with cross functional teams [...]
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[...] team (incl. access, regulatory, HEOR, statistics, medical, clinical) . Lead day-to-day operations for the JCA dossier team: Share Point management, meeting scheduling, agenda drafting, minute-taking, and action tracking. Coordinate cross-functional inputs to ensure timely contribution to JCA strategy and dossier components. Work closely with HEOR to incorporate PICO simulation, consolidation, and feasibility assessments into JCA planning. Oversee evidence retrieval activities and ensure outputs are integrated into the dossier with the JCA writer. Coordinate epidemiology data collection across EEA markets and ensure alignment with Commercial/ Forecasting. Coordinate cross functional LT and EU HTA governance board, GPT review of JCA strategy and JCA dossier. Manage dossier uploads and submissions via the EU HTA IT platform and support procedural interactions with EU HTA Coordination Group. [. .. ] JSC. In alignment with the GVAP portfolio lead, coordinate JSC operational activities incl. collection of cross functional input, request form submission, briefing book development, briefing book review, meeting scheduling, and documentation tracking. Engage SMEs and cross-functional teams to ensure readiness and consistent evidence positions. Project Management Cross-Functional Leadership Communication Develop and maintain comprehensive project timelines for all JCA and JSC activities. Ensure alignment of EU HTA JCA and JSC timelines with regulatory milestones (e. g. , MAA) , in [. .. ]
Job gestern bei Jobleads gefunden
Director, Market Access, Health Technology Assessment Ops Hematology (EU)
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] Dossier Coordination Operations Closely collaborate with the GVAP Portfolio Lead to drive the development of JCA dossier strategy and final JCA dossier delivery with cross functional teams [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] team (incl. access, regulatory, HEOR, statistics, medical, clinical) . Lead day-to-day operations for the JCA dossier team: Share Point management, meeting scheduling, agenda drafting, minute-taking, and action tracking. Coordinate cross-functional inputs to ensure timely contribution to JCA strategy and dossier components. Work closely with HEOR to incorporate PICO simulation, consolidation, and feasibility assessments into JCA planning. Oversee evidence retrieval activities and ensure outputs are integrated into the dossier with the JCA writer. Coordinate epidemiology data collection across EEA markets and ensure alignment with Commercial/ Forecasting. Coordinate cross functional LT and EU HTA governance board, GPT review of JCA strategy and JCA dossier. Manage dossier uploads and submissions via the EU HTA IT platform and support procedural interactions with EU HTA Coordination Group. [. .. ] JSC. In alignment with the GVAP portfolio lead, coordinate JSC operational activities incl. collection of cross functional input, request form submission, briefing book development, briefing book review, meeting scheduling, and documentation tracking. Engage SMEs and cross-functional teams to ensure readiness and consistent evidence positions. Project Management Cross-Functional Leadership Communication Develop and maintain comprehensive project timelines for all JCA and JSC activities. Ensure alignment of EU HTA JCA and JSC timelines with regulatory milestones (e. g. , MAA) , in [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
• Wiesbaden, Hessen
Overview The Senior Medical
Writer is responsible for providing clinical EUHTA document support to the JCA core team, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the [...]
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[...] clinical writing process. The Senior Medical Writer will help to establish the new capability (eg medical writing) for IMAP. Provides HTA medical writing [. .. ] HTA; oncology is a plus within a therapeutic area. Interfaces with JCA core and extended teams (e. g. , HTA Strategy, Access, DSS HTA Stats, VAC, HEOR S, Medical Affairs, Regulatory, Safety) to ensure accurate and timely completion/ delivery of information and review of clinical EUHTA submissions. Responsibilities Demonstrated capability to write all HTA dossier document types in remit, regardless of complexity. Independently writes highly complex clinical JCA submissions documents and dossier components including but not limited to Sections, Appendices of [. .. ] establish medical writing capability within IMAP through the support of process and governance development. Develops knowledge of JCA and international regulations, requirements, and guidelines pertaining to the preparation of JCA documentation. Provides guidance associated with preparation of JCA documentation. Participates in execution of tactical process improvements. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. Qualifications A minimum of 6+ years of bio-pharmaceutical industry experience in global pharma, biotech, [. .. ]
Job vor 8 Tagen bei Jobleads gefunden
• Berlin
Homeoffice möglich
Work-Life-Balance
[. .. ] cancer research in the clinical trial setting. Our passionate team is committed to bringing the cancer treatments of the future to the patients of today. TRIO is [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] seeking a Medical Writer to join our Medical Writing and Training team. This position reports to the Medical Writing Manager and is home-based in Germany. This position is a fixed-term role starting on March 2, 2026, and ending at the end of August 2026. Responsibilities Prepare, edit, and finalize trial-related documents, [. .. ] Clinical Trial Protocols and Synopses Clinical Study Reports Patient Narratives Safety Update Reports Abstracts and Manuscripts for publication Coordinate document-related meetings, including agendas and minutes. Ensure documents meet timelines, regulatory guidelines (ICH) , SOPs, and sponsor requirements. Perform quality control checks and address findings. Maintain and update SOPs and templates for medical writing deliverables. Collaborate on data analysis and interpretation to ensure accuracy in documents. Submit abstracts, presentations, and manuscripts to conferences or journals. Stay current with industry standards and [. .. ] experience as a medical writer, including clinical trial documents. Strong ability to write clear, accurate, and engaging medical/ scientific content for diverse audiences. Proven experience managing multiple trials and related documentation. Solid understanding of clinical research concepts, ICH guidelines, and drug development processes. Familiarity with statistical principles applied to clinical trials. Strong communication and collaboration skills with internal and external stakeholders. Proficiency in Microsoft Office and reference management tools. Native English speaker or highly proficient in English. Must be legally authorized [. .. ]
Job am 06.10.2025 bei Jobleads gefunden
Medical Writer
• Berlin
Abgeschlossenes Studium
[. .. ] cancer research in the clinical trial setting. Our passionate team is committed to bringing the cancer treatments of the future to the patients of today. TRIO is [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] seeking a Medical Writer to join our Medical Writing and Training team. This position reports to the Medical Writing Manager and is home-based in Germany. This position is a fixed-term role starting on March 2, 2026, and ending at the end of August 2026. Responsibilities Prepare, edit, and finalize trial-related documents, [. .. ] Clinical Trial Protocols and Synopses Clinical Study Reports Patient Narratives Safety Update Reports Abstracts and Manuscripts for publication Coordinate document-related meetings, including agendas and minutes. Ensure documents meet timelines, regulatory guidelines (ICH) , SOPs, and sponsor requirements. Perform quality control checks and address findings. Maintain and update SOPs and templates for medical writing deliverables. Collaborate on data analysis and interpretation to ensure accuracy in documents. Submit abstracts, presentations, and manuscripts to conferences or journals. Stay current with industry standards and [. .. ] experience as a medical writer, including clinical trial documents. Strong ability to write clear, accurate, and engaging medical/ scientific content for diverse audiences. Proven experience managing multiple trials and related documentation. Solid understanding of clinical research concepts, ICH guidelines, and drug development processes. Familiarity with statistical principles applied to clinical trials. Strong communication and collaboration skills with internal and external stakeholders. Proficiency in Microsoft Office and reference management tools. Native English speaker or highly proficient in English. Must be legally authorized [. .. ]
Job am 07.09.2025 bei Jobleads gefunden
• Wettenberg, Hessen
[. .. ] add to their department. Responsibilities Develop high-quality English-language product marketing materials, including brochures, website content, and social media posts, while coordinating closely with corporate marketing. Oversee and [...]
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[...] coordinate documentation processes end-to-end, ensuring compliance with regulatory requirements and industry standards. Create precise, order-related operating instructions for products and systems. Act as the technical liaison across departments, conducting research and clarifying complex technical issues. Produce clear and accurate graphical representations of assemblies, layouts, and technical processes. Your Profile You hold a technical degree or completed training as a technical writer, technical product designer, or in a related technical field. You bring solid experience in technical documentation and a strong understanding of mechanical and plant engineering concepts. You are fluent in German and English and communicate confidently in both languages. You have a talent for transforming complex technical content into clear, [. .. ]
Job am 14.08.2025 bei Jobleads gefunden
Medical Writer
[. .. ] will also develop market access content. You should be recognized as a brand expert with an ability to translate the science and data into compelling promotional copy [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] complying with medical, regulatory, legal and compliance guidelines. The aim is to make the complex simple adapting larger pieces of content to create smaller, easy-to-read materials for digital and non-digital channels, maintaining key medical messaging and being able to anchor medical literature references. Creativity, innovative thinking, and problem-solving should be [. .. ] policies, ensuring that content development activities are supported by authentic and up-to-date references. Follow best practices in the department regarding processes, communication (internal and external) , project management, documentation and technical requirements such as language, grammar, stylization, content search, summarizing, data conflicts, and referencing. Participating in assigned training programs and working on assignments as per requirement. Participating in client calls as per project requirements. Use of, overseeing and harnessing the advantages of AI tools in providing accurate and relevant [. .. ]
Job am 05.07.2025 bei Jobleads gefunden
• Wien
[. .. ] software medical device and combination products for all phases of the product lifecycle including design, development, manufacture, distribution, and product support processes. Ensure all device and combination [...]
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[...] product quality and regulatory standards/ requirements are met. Provide quality support for, but not limited to, internal/ external inspections, product submissions/ approvals, CAPA, complaint handling, and change control Represents DQ in support of Scarletredss medical device and combination product development efforts (e. g. , new software applications, changes to existing software applications, bug fixes, [. .. ] assigned medical devices or combination products. Responsible for quality assessment during supplier qualification for assigned development projects. Supports internal and external audits including readiness as an SME on product lifecycle documentation. Can effectively lead and execute commercial lifecycle management support activities including but not limited to change control, deviation investigation, CAPA, and complaint handling Requirements Bachelors or Master Degree in Engineering or equivalent technical discipline required, and at least 5 years of experience working with software medical devices in Quality Assurance [. .. ] Services Referrals increase your chances of interviewing at SCARLETRED Holding Gmb H by 2x Get notified about new Software Quality Engineer jobs in Vienna, Vienna, Austria. Senior Software Test Engineer Documentation Writer (w/m/d) Software Development Engineer in Test II Software Development Engineer in Test III (All Genders) JAVA Software Engineer-Test Automation (f/m/d) Full Stack Software Engineer-Med Tech Vienna or Remote (EU) Lead Golang Software Engineer, Commercial Systems Were unlocking community knowledge in a new way. Experts [. .. ]
Job vor 2 Tagen bei Neuvoo gefunden
Rentschler Biopharma
• Laupheim, Baden- Württemberg
Jobticket
[. .. ] all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. Turn complex biopharmaceutical data into clear insights [...]
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[...] As a Scientific Writer (m/f/d) , you will be responsible for creating precise, scientifically sound documentation for early, late-stage, and commercial process development. Your work ensures transparency and compliance across projects and supports the successful transfer of biopharmaceutical processes from development to manufacturing. Responsibilities and tasks Documentation Analysis Analyze raw data from process development Prepare and review reports from Process Science and Manufacturing Science and [. .. ] project management knowledge Ability to present complex data clearly and logically Strong attention to detail in language, scientific accuracy, and formatting Proficiency in MS Office and JMP Experience in preparing regulatory documents is advantageous Skills in visualizing scientific Content is a plus Affinity for interdisciplinary collaboration What we offer Meaningful Work: Become part of a company that makes a real difference for critically ill patients by developing and producing vital medications Inspiring Work Atmosphere: Experience the joy of working in a [. .. ]
Job vor 10 Tagen bei Neuvoo gefunden
Translational Research in Oncology
Medical Writer
• Berlin
Homeoffice möglich
Work-Life-Balance
[. .. ] cancer research in the clinical trial setting. Our passionate team is committed to bringing the cancer treatments of the future to the patients of today. TRIO is [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] seeking a Medical Writer to join our Medical Writing and Training team. This position reports to the Medical Writing Manager and is home-based in Germany. This position is a fixed-term role starting on March 2, 2026, and ending at the end of August 2026. Responsibilities: Prepare, edit, and finalize trial-related documents, [. .. ] Clinical Trial Protocols and Synopses Clinical Study Reports Patient Narratives Safety Update Reports Abstracts and Manuscripts for publication Coordinate document-related meetings, including agendas and minutes. Ensure documents meet timelines, regulatory guidelines (ICH) , SOPs, and sponsor requirements. Perform quality control checks and address findings. Maintain and update SOPs and templates for medical writing deliverables. Collaborate on data analysis and interpretation to ensure accuracy in documents. Submit abstracts, presentations, and manuscripts to conferences or journals. Stay current with industry standards and [. .. ] experience as a medical writer, including clinical trial documents. Strong ability to write clear, accurate, and engaging medical/ scientific content for diverse audiences. Proven experience managing multiple trials and related documentation. Solid understanding of clinical research concepts, ICH guidelines, and drug development processes. Familiarity with statistical principles applied to clinical trials. Strong communication and collaboration skills with internal and external stakeholders. Proficiency in Microsoft Office and reference management tools. Native English speaker or highly proficient in English. Must be legally authorized [. .. ]
Häufig gestellte Fragen
Wieviel verdient man als Regulatory Documentation Writer pro Jahr?
Als Regulatory Documentation Writer verdient man zwischen EUR 45.000,- bis EUR 70.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Regulatory Documentation Writer Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 10 offene Stellenanzeigen für Regulatory Documentation Writer Jobs.
In welchen Bundesländern werden die meisten Regulatory Documentation Writer Jobs angeboten?
Die meisten Stellenanzeigen für Regulatory Documentation Writer Jobs werden derzeit in Berlin (3 Jobs), Sachsen-Anhalt (2 Jobs) und Hessen (2 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Documentation Writer Jobs?
Regulatory Documentation Writer Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
