20 Jobs für Regulatory Writer
Stellenangebote Regulatory Writer Jobs
Job vor 12 Tagen bei Mindmatch.ai gefunden
K- Recruiting Life Sciences
• Stuttgart, BW
Freiberuflich
Freelance CMC
Regulatory Writer (m/w/D) Aufgaben: Erstellung und Pflege von CMC-relevanten Abschnitten in IMPDs und IND Applications Erstellung regulatorischer Dokumente für klinische Entwicklungsprogramme Phase 13 Vorbereitung von Unterlagen für FDA [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Type B/ C und Pre-IND Meetings Unterstützung bei EMA Scientific Advice Procedures Erstellung von Briefing Books, Meeting Packages, Q A-[. .. ]
Job vor 13 Tagen bei Neuvoo.com gefunden
K- Recruiting Life Sciences
Freelance CMC Regulatory Writer
• Baden- Württemberg
Freiberuflich
Freelance CMC
Regulatory Writer (m/w/D) Aufgaben: Erstellung und Pflege von CMC-relevanten Abschnitten in IMPDs und IND Applications Erstellung regulatorischer Dokumente für klinische Entwicklungsprogramme Phase 13 Vorbereitung von Unterlagen für FDA [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Type B/ C und Pre-IND Meetings Unterstützung bei EMA Scientific Advice Procedures Erstellung von Briefing Books, Meeting Packages, Q A-[. .. ]
Job vor 13 Tagen bei Neuvoo.com gefunden
K- Recruiting Life Sciences
Freelance CMC Regulatory Writer
Freiberuflich
Freelance CMC
Regulatory Writer (m/w/D) Aufgaben: Erstellung und Pflege von CMC-relevanten Abschnitten in IMPDs und IND Applications Erstellung regulatorischer Dokumente für klinische Entwicklungsprogramme Phase 13 Vorbereitung von Unterlagen für FDA [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Type B/ C und Pre-IND Meetings Unterstützung bei EMA Scientific Advice Procedures Erstellung von Briefing Books, Meeting Packages, Q A-[. .. ]
Job am 22.08.2026 bei StepStone gefunden
Unora GmbH
Regulatory Affairs Manager (m/w/d) , Elternzeitvertretung für ca. 2 Jahre
• Berlin
Beratungs-/ Consultingtätigkeiten Teilzeit Homeoffice möglich
Betriebliche Altersvorsorge
[. .. ] Unternehmenskultur. Wenn du nicht nur Teil des Wandels sein, sondern ihn aktiv mitgestalten möchtest, bist du bei uns genau richtig. Zur Unterstützung unseres Teams suchen wir zum [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] nächstmöglichen Zeitpunkt einen Regulatory Affairs Manager (m/w/d) als Elternzeitvertretung für die Dauer von ca. 2 Jahren mit Schwerpunkt auf Erstellung von klinischen Bewertungen, Produktregistrierungen, Vigilanz und Post Market Surveillance. Aufgaben Erstellung und Aktualisierung von klinischen Bewertungen gemäß Artikel 61 der MDR (EU 2017/ 745) Eigenverantwortliche Durchführung und Betreuung von Produktregistrierungen in der [. .. ] Benannten Stellen, Bevollmächtigten und internationalen Partnern Unterstützung bei Audits, Inspektionen und internen Qualitätsprojekten Profil Abgeschlossenes naturwissenschaftliches, technisches oder regulatorisches Studium (z. B. Medizintechnik, Biowissenschaften, Regulatory Affairs) Nachweisbare Erfahrung als Medical Writer im Bereich Medical Devices-praktische Erfahrung beim Erstellen von Clinical Evaluation Plans (CEP) und Clinical Evaluation Reports (CER) Berufserfahrung im Bereich Regulatory Affairs oder Produktzulassung für Medizinprodukte Gute Kenntnisse der regulatorischen Anforderungen für Medizinprodukte der Klasse I gemäß MDR (EU 2017/ 745) Erfahrung in der Erstellung und Pflege von Technischen [. .. ]
Job vor 3 Tagen bei Mindmatch.ai gefunden
Parexel International
• AT- 9 Wien
Führungs-/ Leitungspositionen
[. .. ] Austria. As a Clinical Trial Leader, you will support clinical research activities that advance new treatments for patients. This position plays a key role in study execution, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] patient safety oversight, regulatory compliance, and clinical data accuracy. Youll collaborate with crossfunctional teams, follow industrystandard processes, and contribute to study operations from planning through closeout. Responsibilities include managing the planning, implementation and tracking of the clinical trial processes as well as risk mitigation, with opportunities to deepen your expertise and influence study outcomes. [. .. ] of vendor services (including Central Lab) in conjunction with other functions. In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports trial medical writer in providing the CTR. Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors. Support results/ documents disclosure of global registries. May support publication of trial data. Candidate Profile Youll thrive in this role if you bring: Extensive experience [. .. ]
Job gestern bei Jobleads gefunden
Senior Medical Writer
[. .. ] investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and e CTD submissions, journal manuscripts, abstracts, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] posters, and presentations Apply regulatory standards, company SOPs, client standards, approved templates, authorship requirements, and style/ formatting guides Coordinate quality and editorial reviews Lead team document reviews and review documents as needed Act as peer reviewer for internal teams Review statistical analysis plans and table/ figure/ listing specifications Collaborate with clients and data management, biostatistics, [. .. ]
Job gestern bei Jobleads gefunden
[. .. ] to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. The [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Principal Clinical Medical Writer has functional oversight responsibilities for medical writing staff and for the medical writing requirements for clinical development programs, including authoring/ editing documents. RESPONSIBILITIES: Oversight responsibilities for Medical Writing staff Works with the Head of Medical Writing to establish and maintain timelines for program planning. Drafts and edits documents used in [. .. ] reporting aggregate safety and efficacy information for a molecule, such as investigators brochures and periodic safety reports (e. g. PBRERs, DSURs) Drafts and edits documents used in the preparation of regulatory filings (e. g. briefing books, CTD Module 2/ Module 5 clinical or integrated summaries) . Manages study team participation in the preparation of such documents, including scheduling and chairing meetings, developing and managing timelines, and managing the document review and comment adjudication processes Represents CMW at cross-functional team meetings [. .. ]
Job gestern bei Jobleads gefunden
Associate Director, Medical Regulatory Writing
Führungs-/ Leitungspositionen
Serve as medical
writer and subject matter expert preparing clinical
regulatory documents through all phases of clinical research Execute the clinical trial transparency and disclosure book of work and provide [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] vendor oversight Collaborate with regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, and other crossfunctional teams Manage document review processes and resolve conflicting or ambiguous comments Establish and [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
• Puchheim, Bayern
Flexible Arbeitszeiten Betriebliche Altersvorsorge 30+ Urlaubstage
[. .. ] an der Ladesäule. Mit über 35 Jahren Erfahrung sind wir Technologie- und in einzelnen Segmenten sogar Weltmarktführer als Teil der Allegion plc. verbinden wir Mittelstands-Agilität mit globaler [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Reichweite. Technical Writer (m/w/d) Embedded Systems and RFID Zeppelinstraße 1, 82178 Puchheim, Deutschland Vollzeit Bis zu 50 mobiles Arbeiten Stellenbeschreibung In dieser Rolle erstellst und pflegst Du die technische Dokumentation für unsere RFID-, NFC- und BLE-Produkte von Produktdokumentationen bis zu regulatorischen Unterlagen. Dabei arbeitest Du eng mit Entwicklung, Produktmanagement und Qualitätssicherung zusammen. Technische Produktdokumentation Du erstellst und pflegst Datenblätter, Integrationsleitfäden und Benutzerhandbücher für unsere RFID-, NFC- und BLE-Leser. Regulatory und Certification Du erstellst und pflegst Dokumentationen für Zulassungen und Zertifizierungen, wie FCC, CE, Ro HS, RED und ETSI, sowie länderspezifische Funkzulassungen. Technische Zusammenarbeit gemeinsam mit Entwicklung, Produktmanagement, Qualitätssicherung und externen Zertifizierungsstellen stellst Du sicher, dass technische Inhalte korrekt und aktuell sind. Standards und Qualität Du sorgst für eine einheitliche Terminologie, [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
Medical Writer (Remote, US) (Boston, MA, US)
[. .. ] edits clinical study documentation, including clinical investigational plans/ protocols, Investigators Brochures, Periodic reports, Clinical Investigational Reports/ Clinical Study Reports. Ensure high quality study documentation that is submission-ready [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] for various regulatory agency and external distribution. Serves as a subject matter expert on clinical aspects of Technical documentation. Writes and/or supports the development of manuscripts relating to clinical study data or clinical evidence for submission to peer-reviewed medical journals. Works with medical professionals to ensure alignment with journal requirements for [. .. ]
Job vor 9 Tagen bei Jobleads gefunden
• Hamburg
[. .. ] (m/f/d) with a clinical life science background. In this position, you combine scientific expertise with strategic thinking, you help shape a highquality development pipeline and contribute to [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] strong regulatory outcomes. You will work closely with interdisciplinary teams and external partners to drive projects forward efficiently. This role offers you the opportunity to actively influence clinical development decisions and create real value for customers. Become part of a dynamic environment where your work has a real impact Your tasks: You [. .. ] This also includes consultation and design of trial concepts with competent authorities and the preparation of scientific advice packages. Part of your role will also include tasks as a Medical Writer, where you prepare and review scientific documentation on the efficacy and safety of our products. Here, you ensure the timely preparation of nonclinical and clinical documentation for regulatory submissions, including the commissioning and review of modules2.4 and2.5. In doing so, you respond to deficiency letters during registration procedures [. .. ]
Job vor 10 Tagen bei Jobleads gefunden
Senior Medical Writer Promotional Medical Writing
[. .. ] good publication practice, and company policies Work with account teams to refine content according to strategic imperatives Communicate medical content with internal teams and pharmaceutical clients Attend [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] medical, legal, and regulatory review meetings as needed Participate in project kick-off, status, client, brainstorm, and review meetings Contribute ideas for new business proposals and tactical planning Mentor junior staff Travel for occasional client meetings Requirements BA/ BS in life sciences BA/ BS in English combined with experience in a pharmaceutical agency, medical [. .. ]
Job am 30.08.2026 bei Jobleads gefunden
• Puchheim, Bayern
Flexible Arbeitszeiten Betriebliche Altersvorsorge 30+ Urlaubstage
[. .. ] regulatorischen Unterlagen. Dabei arbeitest Du eng mit Entwicklung, Produktmanagement und Qualitätssicherung zusammen. Technische Produktdokumentation Du erstellst und pflegst Datenblätter, Integrationsleitfäden und Benutzerhandbücher für unsere RFID-, NFC- und [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] BLE-Leser. Regulatory Certification Du erstellst und pflegst Dokumentationen für Zulassungen und Zertifizierungen wie FCC, CE, Ro HS, RED und ETSI sowie länderspezifische Funkzulassungen. Technische Zusammenarbeit Gemeinsam mit Entwicklung, Produktmanagement, Qualitätssicherung und externen Zertifizierungsstellen stellst Du sicher, dass technische Inhalte korrekt und aktuell sind. Standards Qualität Du sorgst für eine einheitliche Terminologie, Struktur und [. .. ] ist, nutzt Du KI aktiv zur Unterstützung Deiner Arbeit von Recherche und Strukturierung über Erstellung und Überarbeitung bis zur Pflege und Aktualisierung von Dokumentationen. Berufserfahrung Du hast Erfahrung als Technical Writer in einem Umfeld wie Elektronik, Embedded Systems, Io T oder RFId/NFC. Alternativ kommst Du aus einem technischen Bereich, z. B. Embedded Support oder Engineering, und möchtest Dich gezielt in Richtung Technical Writing entwickeln. Technisches Verständnis Du bist bereit, Dich tief genug in unsere RFID-, NFC- und BLE-Produkte sowie [. .. ]
Job am 23.08.2026 bei Jobleads gefunden
Technical Writer-Robotics (Human)
• Riederich, Baden- Württemberg
[. .. ] Documentation and Product Documentation This role focuses on creating, structuring, and continuously improving standards-compliant product documentation for robotics products, while helping to make technical documentation future-proof for [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] upcoming regulatory, digital, terminology, and AI-supported documentation requirements. Your general tasks: Creation of high-quality, standards-compliant technical documentation in English, tailored to the relevant target groups (e. g. , operating, user, assembly, repair, and maintenance instructions, software manuals, and system documentation) Structured creation, maintenance, and further development of modular content [. .. ] collaboration with interdisciplinary, cross-site teams throughout the product development process Use of modern collaboration and knowledge-management tools: Confluence, Jira, Teams, Share Point Your profile: Training as a Technical Writer or a comparable qualification; alternatively, a technical degree or graduation from a technical college, preferably with a focus on technical communication or technical documentation At least three years of professional experience in creating technical documentation or comparable practical experience in technical communication Excellent writing skills and the ability to present [. .. ]
Job am 21.08.2026 bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: As part of our expanding European organization, we are seeking [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] an experienced Principal Regulatory Medical Writer to support the preparation of high-quality regulatory documentation for clinical development and marketing authorization activities across Europe. Working closely with Regulatory Affairs, Clinical Development, Clinical Operations, Biometrics, Pharmacovigilance, CMC, and other cross-functional teams, the successful candidate will author, coordinate and finalize regulatory documents supporting interactions with European and [. .. ]
Job am 21.08.2026 bei Jobleads gefunden
Europe Regulatory Medical Writing Lead
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
Revolution Medicines is seeking an experienced Principal
Regulatory Medical
Writer to lead the preparation of regulatory documentation for clinical development and marketing authorization across Europe. You will collaborate [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] with Regulatory Affairs, Clinical Development, and cross-functional teams to author, coordinate and finalize submissions. The role reports to the VP, Regulatory Affairs, Europe. You will serve as lead author for complex [. .. ]
Job am 18.08.2026 bei Jobleads gefunden
[. .. ] powered advice on this job and more exclusive features. Direct message the job poster from Life Sciences Recruitment Senior Consultant Experienced Traveller Ex Professional Golfer Average Footballer [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Job Title: Medical Writer Promotional Materials (Remote, Germany) Are you a talented Medical Writer with a passion for crafting compelling, scientifically accurate promotional content? Join a leading Medical Communications agency and help shape impactful materials for top healthcare and pharmaceutical clients. About the Role As a Medical Writer, youll focus on developing high-quality [. .. ] EFPIA) Stay up to date with therapeutic area trends and medical advancements About You Experience in Medical Writing, preferably within Med Comms or Pharma Strong knowledge of promotional materials and regulatory requirements Ability to translate complex scientific data into clear, compelling narratives Excellent attention to detail and ability to work in a fast-paced environment Fluent in English and German Whats in it for You? Fully remote role work from anywhere in Germany Competitive salary benefits package Opportunity to work with [. .. ]
Job am 18.08.2026 bei Jobleads gefunden
GRC Engineer-Platform Team
• Berlin
Homeoffice möglich
[. .. ] backbone, not a point-in-time checklist. Technically handson: comfortable scripting against AWS APIs to automate evidence collection, with a solid grasp of software development and security concepts. A [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] strong writer and communicator who can turn around a 200-row security questionnaire quickly and accurately, and translate fluently between compliance and technical teams. Ideal, but not required Experience with customer trust programs (Trust Center, FAQs, security whitepapers) . DORA/ EU AI Act/ fintech regulatory exposure. Has shipped engineeringled automation (not just dashboards) . Familiarity with NIST CSF, CIS Controls, or GDPR/ DPAs. What We Offer Work with colleagues that lift you up, challenge you, celebrate you and help you grow. We come from many different backgrounds, but what we have in common is the [. .. ]
Job am 18.08.2026 bei Jobleads gefunden
• Berlin
Führungs-/ Leitungspositionen Homeoffice möglich
[. .. ] marrying a problem to its solution Are experienced at hiring, onboarding, and managing PR agencies Are adept in pre-IPO communications Have experience and/or heavy interest in policy [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and regulatory communications Are an exceptional writer with a talent for distilling complex, cross-functional topics into simple, compelling narratives Have experience serving as a communications business partner or trusted advisor to senior leaders, executives, and people/ human resources teams Are highly organised and process-driven, with strong project management skills and a bias for action Bring [. .. ]
Job am 18.08.2026 bei Jobleads gefunden
Lead Technical Writer for Medical Devices
• Bonaduz, Graubünden
Führungs-/ Leitungspositionen
[. .. ] a dedicated Team Lead for our information developers delivering end-user documentation for our devices and related products. You will lead a small team, collaborate with engineering, clinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] input, and regulatory bodies, ensuring on-time, high-quality documentation. Requirements include proven end-user documentation experience, ability to absorb complex procedures, and fluency in English with German willingness. #J-18808-Ljbffr 01428265 [. .. ]
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 20 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 Baden-Württemberg (3 Jobs), Berlin (3 Jobs) und Bayern (2 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Writer Jobs?
Regulatory Writer Jobs gehören zum Berufsfeld Technische Dokumentation / Redaktion.
