22 Jobs für Regulatory Writer
Stellenangebote Regulatory Writer Jobs
Job am 21.04.2026 bei Mindmatch.ai gefunden
Croma- Pharma
• AT- 3 Gemeinde Leobendorf
An international pharmaceutical company in Leobendorf is looking for an experienced
regulatory writer. The role involves writing clinical and regulatory documents, ensuring compliance with EU regulations, and supporting global submissions. [...]
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[...] Required qualifications include a Masters degree in life sciences, at least 3 years of relevant experience, and strong English skills. The position offers flexible working hours, a competitive salary based on qualifications, and [. .. ]
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Job am 20.04.2026 bei Jobleads gefunden
Regulatory Medical Writer Clinical Submissions (Hybrid)
• Gemeinde Leobendorf, Niederösterreich
An international pharmaceutical company in Leobendorf is looking for an experienced
regulatory writer. The role involves writing clinical and regulatory documents, ensuring compliance with EU regulations, and supporting global submissions. [...]
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[...] Required qualifications include a Masters degree in life sciences, at least 3 years of relevant experience, and strong English skills. The position offers flexible working hours, a competitive salary based on qualifications, and [. .. ]
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Job am 20.04.2026 bei Mindmatch.ai gefunden
Croma- Pharma
• AT- 3 Gemeinde Leobendorf
Homeoffice möglich
[. .. ] Pharma, we are committed to developing and marketing innovative products that help our customers improve their wellbeing. Join us and grow with us. Responsibilities Write, review and [...]
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[...] maintain clinical and regulatory documents across the product lifecycle (e. g. Clinical Evaluation Plans and Reports, PMCF Plans and Reports, PSURs, Investigators Brochures) . Ensure compliance with applicable regulations and guidelines (EU MDR 2017/ 745, ICH-GCP, ISO 14155, FDA 21CFR) . Coordinate document review and approval processes, including comment reconciliation with internal stakeholders [. .. ]
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Job am 08.04.2026 bei Jooble gefunden
Senior Business Audit Manager
• Berlin Berlin, DE
About the opportunity The Senior Manager, Business Audit supports internal audit activities across the N26 group, including external contractors and subsidiaries, in line with professional and
regulatory standards. Key responsibilities [...]
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[...] include developing and executing a comprehensive risk-based annual audit plan, managing the full audit cycle to ensure operational effectiveness, compliance, and reliability, and auditing both in-house and outsourced processes. The position requires preparing detailed audit reports, regularly communicating findings and agreed actions to management and [. .. ] stakeholders and to withstand management pushback. Proficiency in audit tools, data analytics, and reporting systems Deep understanding of operational and financial (key) controls, process optimization, and risk mitigation Strong report writer focus on legal and factual subsumption. Robust and defensible reporting, Audit Leadership and audit quality assurance Whats in it for you: Accelerate your career growth by joining one of Europes most talked about disruptors. Employee benefits that range from a competitive personal development budget, work from home budget, discounts to [. .. ]
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Neu Job vor 4 Std. bei Jobleads gefunden
• Frankfurt, Hesse
ICON Beijing/ Shanghai Sr. Medical
Writer ICON plc is a worldleading healthcare intelligence and clinical research organization. Were proud to foster an inclusive environment driving innovation and excellence, and we [...]
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[...] welcome you to join us on our mission to shape the future of clinical development. As a Senior Medical Writer at ICON, you will lead the [. .. ] applying your expertise to complex challenges. Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs) , investigator brochures (IBs) , and regulatory submissions, ensuring accuracy, clarity Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, [. .. ]
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Job vor 4 Tagen bei Jobleads gefunden
FSP Principal Medical Writer-Germany (m/f/d)
FSP Principal Medical
Writer-Germany (m/f/d) Work Schedule: Standard (Mon-Fri) Environment: Office Job Summary We are expanding our Medical Writing FSP Team in Germany. This remote role will work from any [...]
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[...] location in Germany. The Principal Medical Writer will lead writing for a client in the FSP space, providing highquality medical [. .. ] and scientific documents (IBs, INDs, MAAs) and provide senior level review of routine and complex documents. Provide training and mentorship for writers and program managers on document preparation, software use, regulatory requirements, and therapeutic area knowledge. Ensure compliance with quality processes and regulatory requirements; develop and review best practices and lead process improvement initiatives. Represent the department at project launch and review meetings. Education Experience Bachelors degree in a scientific discipline or equivalent; advanced degree preferred. 8+ years of relevant experience, [. .. ]
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Job am 22.04.2026 bei Jobleads gefunden
• Frankfurt, Hesse
[. .. ] continuously advancing the documentation ecosystem for all Secusmart products in German and English. You hold endtoend responsibility for customerfacing product documentation, ensuring content is accurate, usercentric, compliant [...]
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[...] with corporate and regulatory standards, and aligned with highly secure, missioncritical product environments. In this senior capacity, you not only deliver highquality documentation but also serve as a trusted subjectmatter leader, influencing documentation strategy, standards, and best practices across the organization. Key Responsibilities Documentation Leadership Ownership Own the endtoend lifecycle of customerfacing documentation for [. .. ] experience creating professional technical documentation in both languages. Strong command of technical writing methodologies, documentation standards, and structured content principles. Professional Experience 5-10+ years of experience as a Technical Writer or Content Architect, with demonstrated progression to seniorlevel responsibility. Proven experience documenting complex software systems, preferably in securitysensitive, enterprise, or regulated environments. Familiarity with documentation requirements for government, defense, or regulated markets, including approval processes, audits, or formal evaluations will be an asset. Handson experience owning the endtoend documentation lifecycle, [. .. ]
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Job am 20.04.2026 bei Jobleads gefunden
Medical Writer (m/f/d)
• Gemeinde Leobendorf, Niederösterreich
Homeoffice möglich
[. .. ] Pharma, we are committed to developing and marketing innovative products that help our customers improve their wellbeing. Join us and grow with us. Responsibilities Write, review and [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] maintain clinical and regulatory documents across the product lifecycle (e. g. Clinical Evaluation Plans and Reports, PMCF Plans and Reports, PSURs, Investigators Brochures) . Ensure compliance with applicable regulations and guidelines (EU MDR 2017/ 745, ICH-GCP, ISO 14155, FDA 21CFR) . Coordinate document review and approval processes, including comment reconciliation with internal stakeholders [. .. ]
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Job am 19.04.2026 bei Jobleads gefunden
Senior Technical Content Architect Black Berry Secusmart
• Düsseldorf, Nordrhein- Westfalen
[. .. ] continuously advancing the documentation ecosystem for all Secusmart products in German and English. You hold endtoend responsibility for customerfacing product documentation, ensuring content is accurate, usercentric, compliant [...]
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[...] with corporate and regulatory standards, and aligned with highly secure, missioncritical product environments. In this senior capacity, you not only deliver highquality documentation but also serve as a trusted subject matter leader, influencing documentation strategy, standards, and best practices across the organization. Key Responsibilities Own the endtoend lifecycle of customerfacing documentation for all Black [. .. ] proven experience creating professional technical documentation in both languages. Strong command of technical writing methodologies, documentation standards, and structured content principles. Professional Experience 510+ years of experience as a Technical Writer or Content Architect, with demonstrated progression to seniorlevel responsibility. Proven experience documenting complex software systems, preferably in securitysensitive, enterprise, or regulated environments. Familiarity with documentation requirements for government, defense, or regulated markets, including approval processes, audits, or formal evaluations will be an asset. Handson experience owning the endtoend documentation lifecycle, [. .. ]
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Job am 19.04.2026 bei Jobleads gefunden
Senior Technical Content Architect Black Berry Secusmart
• Berlin
[. .. ] continuously advancing the documentation ecosystem for all Secusmart products in German and English. You hold endtoend responsibility for customerfacing product documentation, ensuring content is accurate, usercentric, compliant [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] with corporate and regulatory standards, and aligned with highly secure, missioncritical product environments. In this senior capacity, you not only deliver highquality documentation but also serve as a trusted subjectmatter leader, influencing documentation strategy, standards, and best practices across the organization. Key Responsibilities Own the endtoend lifecycle of customerfacing documentation for all Black Berry [. .. ] proven experience creating professional technical documentation in both languages. Strong command of technical writing methodologies, documentation standards, and structured content principles. Professional Experience 510+ years of experience as a Technical Writer or Content Architect, with demonstrated progression to seniorlevel responsibility. Proven experience documenting complex software systems, preferably in securitysensitive, enterprise, or regulated environments. Familiarity with documentation requirements for government, defense, or regulated markets, including approval processes, audits, or formal evaluations will be an asset. Handson experience owning the endtoend documentation lifecycle, [. .. ]
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Job am 17.04.2026 bei Jobleads gefunden
• Iphofen (VGem) , Bayern Iphofen (VGem)
Führungs-/ Leitungspositionen Homeoffice möglich
[. .. ] say yes? What youll do Lead and elevate EMEA safety leadership mentoring H S professionals and management, building strong talent pipelines, and ensuring gapless, regionwide training for [...]
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[...] technical, organizational, and regulatory competence Own H S strategy and governancedeploy policies and Group Safety Standards across EMEA in line with corporate goals and regional regulations, staying ahead of evolving Knauf and legal requirements Safeguard compliance endtoendoversee Risk Management and highrisk operations across plants and offices; drive audits, process/ equipment reviews, site inspections, and [. .. ] practical, shopfloor solutions Deep command of H S regulations, standards, and best practices; strong analytical problemsolver experienced in comprehensive risk assessments, audits, and incident investigations Exceptional communicator and people leaderclear writer and presenter for all audiences; adept at organizing, motivating, and leading diverse teams, collaborating crossfunctionally, and designing and delivering impactful training programs What we offer you Security: Permanent employment contract in a stable, successful familyowned company Flexibility: 30 days of vacation, special leave for certain occasions, flexitime account with a [. .. ]
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Job am 12.04.2026 bei Jobleads gefunden
Manager Quality Regulatory Affairs (m/w/d) - Voll-oder Teilzeit (min. 25 h)
• Bargteheide, Schleswig- Holstein
Teilzeit Abgeschlossenes Studium
Betriebliche Altersvorsorge Mitarbeiterevents
Manager Quality
Regulatory Affairs (m/w/d) - Voll-oder Teilzeit (min. 25 h) Weiterentwicklung des Qualitätsmanagementsystems (QMS) für Medizinprodukte und Qualitätsmanagementhandbuchs (QMH) Erstellung, Prüfung und Schulung SOPs unter Beachtung der gesetzlichen [...]
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[...] und normativen Regelungen hinsichtlich der MDR, FDA ISO 13485 Gestaltung und Überwachung des Konformitätsbewertungsprozesses gemäß MDR, FDA ISO 13485 Vorbereitung, Durchführung und Nachbereitung interner und externer Audits Beteiligung an Produktentwicklungsprojekten und Unterstützung der technischen Abteilungen bei regulatorischen Fragestellungen Steuerung der Dienstleister, insbesondere Testlabore und Medical Writer Erfahrung im Qualitätsmanagement oder Regulatory Affairs in der Medizintechnikbranche oder einem ähnlichen Umfeld Verständnis der Prinzipien und Anforderungen von MDR und ISO 13485 Studienabschluss in Ingenieurwissenschaften, Life Sciences, einer ähnlichen technischen Studienrichtung oder gleichwertige praktische Erfahrung Teamplayer mit umfassenden Kommunikations- und Problemlösungsfähigkeiten Arbeits- und Kommunikationsfähigkeit in Wort und Schrift in [. .. ]
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Job am 05.04.2026 bei Jobleads gefunden
• Berlin
About The Opportunity The Senior Manager, Business Audit supports internal audit activities across the N26 group, including external contractors and subsidiaries, in line with professional and
regulatory standards. Key [...]
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[...] responsibilities include developing and executing a comprehensive riskbased annual audit plan, managing the full audit cycle to ensure operational effectiveness, compliance, and reliability, and auditing both inhouse and outsourced processes. The position requires preparing detailed audit reports, regularly communicating findings and agreed actions to management and committees, monitoring [. .. ] stakeholders and to withstand management pushback. Proficiency in audit tools, data analytics, and reporting systems. Deep understanding of operational and financial (key) controls, process optimisation, and risk mitigation. Strong report writer focus on legal and factual subsumption. Robust and defensible reporting. Audit leadership and audit quality assurance. Whats In It For You Accelerate your career growth by joining one of Europes most talked about disruptors. Employee benefits that range from a competitive personal development budget, work from home budget, discounts to [. .. ]
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Job am 28.03.2026 bei Jobleads gefunden
Technical Editor (m/f/d)
• Wettenberg, Hessen
[. .. ] English-language product marketing materials, including brochures, website content, and social media posts, while coordinating closely with corporate marketing. Oversee and coordinate documentation processes end-to-end, ensuring compliance with [...]
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[...] 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, [. .. ]
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Job am 27.03.2026 bei Jobleads gefunden
• Mainz, Rheinland- Pfalz
Führungs-/ Leitungspositionen
[. .. ] Role As an Associate Director Scientific/ Medical Writing, you will play a pivotal role in advancing Bio NTechs mission to revolutionize medicine by ensuring the timely creation [...]
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[...] of highquality scientific and regulatory documents. Your contributions will directly impact the development and approval of novel therapeutic agents, supporting Bio NTechs efforts to address diseases with high medical needs. Collaborating within a dynamic and innovative environment, you will work closely with crossfunctional teams to maintain excellence in scientific communication. You will join a workplace that [. .. ] background knowledge in immunology and oncology. 5 years (handson) experience: working in drug development in a therapeutically relevant field, preferably in oncology and/or immunology. as a scientific and medical writer in the pharmaceutical/ biotech industry. Prior experience: drafting documents for multiple indications, preferably in Bio NTechrelevant indications. drafting alone new or updated CTPs and CSRs required for Phase IIII trials. drafting low to medium complexity variants of the following (new or updated variants) : IBs, clinical CTD modules, DSURs/ Annual Reports, [. .. ]
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Job am 26.03.2026 bei Jobleads gefunden
Commercial Counsel/ Senior Commercial Counsel
• Fully, Wallis
[. .. ] Rx, so we need team members that are at the top of their game and can shift gears, alter direction, and keep going at pace. You must [...]
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[...] be a playbook writer and executor, able to make plans that both meet the current moment and contemplate the future and then implement them. No matter your job level, you will own your work from beginning to end, take feedback well, prioritize what matters, never rest on your laurels, stay positive and resilient, and [. .. ] complex or highrisk issues appropriately and collaborate with other members of the legal team Help develop and improve contract templates, playbooks, and contracting processes Stay current on relevant legal and regulatory developments as well as industry trends affecting commercial transactions and Nuvem Rxs business Qualifications J. D. from an accredited law school Active bar membership in at least one U. S. jurisdiction, in good standing 47 years of experience negotiating and drafting commercial contracts with substantial time at a law firm [. .. ]
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Job am 17.03.2026 bei Jobleads gefunden
• Frankfurt, Hesse
We are seeking a Principal Medical
Writer to support full Clinical Study Report (CSR) writing for Phase 1, protocol development, and preparation of
regulatory modules (2.7. 1/ 2.7. [...]
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[...] 2) . This role requires strong writing skills and attention to detail to ensure high-quality, inspectionready deliverables. Key Responsibilities Ensure all deliverables are inspectionready and compliant with regulatory and internal guidelines Maintain central planning for document writing and QC deliverables Provide recommendations for [. .. ]
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Job am 11.03.2026 bei Jobleads gefunden
Associate Director, Regulatory Medical Writing, Oncology
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https:/ [...]
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[...] / Associate Director, Regulatory Medical Writing, Oncology Requisition Numbers United States Requisition Number: R-061111 United Kingdom Requisition Number: R-062446 Switzerland Requisition Number: R-062450 Netherlands Belgium Requisition Number: R-062452 Canada Requisition Number: R-062453 Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose Able to function as a lead writer on any compound independently. Leads in setting functional tactics/ strategy. Leads project-level strategy (eg, submission team, global program team, clinical team) . May represent therapeutic area (TA) head at high-level and cross-functional TA meetings and has some independent decision-making authority. Able to write and coordinate complex [. .. ]
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Job am 04.03.2026 bei Jobleads gefunden
[. .. ] 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 [...]
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[...] 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 [. .. ]
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Job am 02.02.2026 bei Jobleads gefunden
Manager, Strategic HTA Writer
• Wiesbaden, Hessen
[. .. ] areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at Job [...]
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[...] Description The HTA 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 clinical writing process. Provides HTA writing expertise for multiple compounds and/or projects, expertise in 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 Strategy, Medical Affairs, Regulatory, Safety) to ensure accurate and timely completion/ delivery of information and review of EUHTA submissions. Responsibilities Able to write less complex document types (unmet need, disease burden sections) , with little supervision. Requires close supervision/ mentoring on more complex document type and relies on review of subject matter experts and [. .. ]
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Job am 21.12.2025 bei Jobleads gefunden
Freelance Technical Writer (m/f/d) Medical Technology/ Regulatory Documentation
Freiberuflich
Freelance Technical
Writer (m/f/d) Medical Technology/
Regulatory Documentation Germany Freelance Technical Writer (m/f/d) Medical Technology/ Regulatory Documentation Remote Start: immediately Project-based/by arrangement About us We are an innovative [...]
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[...] Med Tech start-up (Cor Lector Gmb H) based in Nuremberg that develops software solutions for cardiology. Our products are about to be approved, which is [. .. ]
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Job am 25.04.2026 bei Neuvoo.com gefunden
N26 GmbH
Senior Business Audit Manager
[. .. ] more than 80 nationalities. About the opportunity The Senior Manager, Business Audit supports internal audit activities across the N26 group, including external contractors and subsidiaries, in line [...]
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[...] with professional and regulatory standards. Key responsibilities include developing and executing a comprehensive risk-based annual audit plan, managing the full audit cycle to ensure operational effectiveness, compliance, and reliability, and auditing both in-house and outsourced processes. The position requires preparing detailed audit reports, regularly communicating findings and agreed actions to management and [. .. ] stakeholders and to withstand management pushback. Proficiency in audit tools, data analytics, and reporting systems Deep understanding of operational and financial (key) controls, process optimization, and risk mitigation Strong report writer focus on legal and factual subsumption. Robust and defensible reporting, Audit Leadership and audit quality assurance Accelerate your career growth by joining one of Europes most talked about disruptors. Employee benefits that range from a competitive personal development budget, work from home budget, discounts to fitness wellness memberships, language apps [. .. ]
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Häufig gestellte Fragen
Wieviel verdient man als Regulatory Writer pro Jahr?
Als Regulatory Writer verdient man zwischen EUR 50.000,- bis EUR 80.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Regulatory Writer Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 22 offene Stellenanzeigen für Regulatory Writer Jobs.
In welchen Bundesländern werden die meisten Regulatory Writer Jobs angeboten?
Die meisten Stellenanzeigen für Regulatory Writer Jobs werden derzeit in Berlin (3 Jobs), Hessen (2 Jobs) und Sachsen-Anhalt (2 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Writer Jobs?
Regulatory Writer Jobs gehören zum Berufsfeld Technische Dokumentation / Redaktion.