17 Jobs für Regulatory Medical Writer
Stellenangebote Regulatory Medical Writer Jobs
Job vor 8 Tagen bei Jobleads gefunden
• Mainz, Rheinland- Pfalz
Führungs-/ Leitungspositionen
Mainz, Germany full time Job ID: 11231 About the Role As an Associate Director Scientific/
Medical Writing, you will play a pivotal role in advancing Bio NTechs mission to revolutionize [...]
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[...] medicine by ensuring the timely creation 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, [. .. ]
Job vor 9 Tagen bei Jobleads gefunden
• 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 [. .. ] growing legal team Meaningful ownership of commercial legal work with direct business impact Collaborative, missiondriven environment in the pharmacy services space Additional Benefits And Perks Paid holidays Paid family and medical leave, including paid parental leave Generous medical, dental and vision benefits for employees Companysponsored 401 (k) with a match Life and longterm disability coverage Employee assistance program If you take pride in delivering results, embrace challenges, and proactively seek improvement then Nuvem Rx is the place for you. You will [. .. ]
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. 2) . [...]
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[...] 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 [. .. ]
Job am 16.03.2026 bei Jobleads gefunden
Principal Medical Writer Clinical Pharmacology (m/w/d)
• Frankfurt, Hesse
Principal
Medical Writer Clinical Pharmacology (m/w/d) page is loaded # # Principal Medical Writer Clinical Pharmacology (m/w/d) locations: Frankfurt, Hesse, Germany: Dublin, Ireland: Paris, France: Madrid, Spaintime type: Full timeposted [...]
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[...] on: Posted Todaytime left to apply: End Date: June 5, 2026 (30+ days left to apply) job requisition id: R1521061 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. 2) . This role requires strong writing skills and attention to detail to ensure high-quality, inspection-ready deliverables. # # # # # # Key Responsibilities: + Ensure all deliverables are inspection-ready and compliant with regulatory and internal guidelines + [. .. ]
Job am 11.03.2026 bei Jobleads gefunden
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their [...]
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[...] merit. Job Function Medical Affairs Group Job Sub Function Medical Writing Job Category People Leader All Job Posting Locations Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, South Holland, Netherlands, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada Job Description [. .. ] 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:/ / 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 [. .. ]
Job am 04.03.2026 bei Jobleads gefunden
We are looking for a talented professional with Copywriting skills focused on the
Medical Industry, who can work on developing copy content for brand deliverables. This role would complement the [...]
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[...] design team, while working for our client in the pharmaceutical industry. The focus of the role will be to create promotional communication content. This role 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 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 [. .. ]
Job am 02.02.2026 bei Jobleads gefunden
• Wiesbaden, Hessen
Company Description Abb Vies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the
medical challenges of tomorrow. We strive to [...]
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[...] have a remarkable impact on peoples lives across several key therapeutic 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 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 [. .. ]
Job am 21.12.2025 bei Jobleads gefunden
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 [. .. ]
Job am 15.03.2026 bei Neuvoo gefunden
IQVIA
Principal Medical Writer Clinical Pharmacology (m/w/d)
• Frankfurt, Hessen
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. 2) [...]
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[...] . This role requires strong writing skills and attention to detail to ensure high-quality, inspection-ready deliverables. Key Responsibilities: Ensure all deliverables are inspection-ready and compliant with regulatory and internal guidelines Maintain central planning for document writing and QC deliverables Provide [. .. ]
Job am 15.03.2026 bei Neuvoo gefunden
Abb Vie
Manager, Strategic HTA Writer
• Wiesbaden, Hesse
Job 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 [...]
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[...] 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 [. .. ]
Job am 12.03.2026 bei Neuvoo gefunden
Veristat
Principal Medical Writer
Job Description : Principal
Medical Writer The Principal Medical Writer independently plans and prepares a range of
regulatory documents and medical communications to support all phases of product development. [...]
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[...] The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards. The Principal Medical Writer works under [. .. ]
Job am 08.03.2026 bei Neuvoo gefunden
Immunic AG
Senior Consultant (m/f/x) - Medical Writing, Clinical Pharmacology
• Gräfelfing, Bavaria
Beratungs-/ Consultingtätigkeiten
Your mission We are looking for a Consultant (m/f/x) to support our
Medical Writing activities in connection with a NDA submission. This assignment can be done remotely from the [...]
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[...] EU, UK or US (preferably East Coast) , and includes: Collaboration with our internal team members on our NDA preparation by writing clinical modules (AMDE, DDI, FE/ FA, BE, TQT, COC) Support our clinical pharmacology experts as lead medical writer Provide project management for clinical pharmacology modules Interact with non-clinical pharmacology experts, internal and external reviewers Time commitment: 32h/ week Project duration: appr. 12 months Your profile Solid experience in writing NDA/ MAA/ e CTD clinical modules and clinical pharmacology/ Phase 1 study strictly required Medical or science degree with substantial medical/ regulatory writing experience in Biotech or Pharma Native-level English proficiency Strong understanding of drug development processes, regulatory interactions, and applicable global regulations (especially US FDA) Proficient with relevant software tools, style guides, and document formatting standards Excellent project management incl. leading cross-functional, international teams Collaborative and proactive approach, and [. .. ]
Job am 07.03.2026 bei Neuvoo gefunden
Dr. Falk Pharma GmbH
Global Medical Scientific Writer-70 part-time (m/f/d)
• Freiburg im Breisgau, Baden- Württemberg
[. .. ] esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis. Our aim: to meaningfully improve therapeutic practice as well as patient health and well-being. We firmly [...]
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[...] believe that medical progress can only be achieved by working together. That is why we are looking for: Your tasks Dr. Falk Pharma is a research-based pharmaceutical company committed to bringing innovative new medicines to patients with gastroenterological and hepatic diseases. To bridge the divide from clinical research to clinical practice, we are looking for a qualified and motivated individual to translate clinical science for healthcare professionals, regulatory authorities, and other internal and external stakeholders. You are a healthcare enthusiast who is capable of adeptly assimilating and interpreting clinical efficacy and safety data or other scientific content into a logical, scientifically balanced compelling medical narrative for the appropriate audience. Your tasks: Planning, writing, reviewing and submitting manuscripts on [. .. ]
Job am 07.03.2026 bei Neuvoo gefunden
Immunic AG
Senior Consultant (m/f/x) - Medical Writing, Clinical NDA modules
• Gräfelfing, Bavaria
Beratungs-/ Consultingtätigkeiten
Your mission We are looking for a Consultant (m/f/x) to support our
Medical Writing activities in connection with a NDA submission. This assignment can be done remotely from the [...]
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[...] EU, UK or US (preferably East Coast) , and includes: Collaboration with our internal team members on our NDA preparation by writing clinical modules (efficacy and safety) Support our medical experts as lead medical writer Provide project management for NDA submission modules 5 and 2 (clinical sections) Interact with internal and external reviewers Time commitment: 40 h/ week Project duration: appr. 12 months, extension possible Your profile Solid experience in writing NDA/ MAA/ e CTD clinical modules strictly required Medical or science degree with substantial medical/ regulatory writing experience in Biotech or Pharma Native-level English proficiency Strong understanding of drug development processes, regulatory interactions, and applicable global regulations (especially US FDA) Proficient with relevant software tools, style guides, and document formatting standards Excellent project management incl. leading cross-functional, international teams Collaborative and proactive approach, and [. .. ]
Job am 27.02.2026 bei Neuvoo gefunden
HELM AG
(Senior) Clinical Trial Manager (m/f/d)
• 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 [...]
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[...] 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 [. .. ] program. 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 modules 2.4 and 2.5. In doing so, you respond to deficiency letters during [. .. ]
Job am 26.02.2026 bei Neuvoo gefunden
Veristat
Senior Medical Writer
Job Description : Senior
Medical Writer The Senior Medical Writer independently plans and prepares a range of
regulatory documents and medical communications to support all phases of product [...]
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[...] development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards. The Senior Medical Writer works under [. .. ]
Job am 28.01.2026 bei Neuvoo gefunden
Align Technology
Translation Coordinator (m/w/d)
• Darmstadt, Hesse
Homeoffice möglich
Jobticket
[. .. ] (m/w/d) (part time) As Translation Coordinator, you will handle and monitor translation projects and work on improving the existing procedures. You will work closely together with the [...]
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[...] Technical Writer team, the development department, the marketing department and quality management. When performing translations for exocads medical applications, you will ensure that the translation projects are performed according to the regulatory requirements for medical products. The main tasks include Coordination of translation projects with internal and external resources Creation and maintenance of translation databases and glossaries Testing translations in the user interface of our software products Working on a technical infrastructure for handling translations with internal and external tools (e. g. [. .. ]
Häufig gestellte Fragen
Wieviele offene Stellenangebote gibt es für Regulatory Medical Writer Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 17 offene Stellenanzeigen für Regulatory Medical Writer Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Regulatory Medical Writer Jobs?
Aktuell suchen 8 Unternehmen nach Bewerbern für Regulatory Medical Writer Jobs.
Welche Unternehmen suchen nach Bewerbern für Regulatory Medical Writer Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Regulatory Medical Writer Stellenangebote:
- Veristat (2 Jobs)
- Immunic AG (2 Jobs)
- IQVIA (1 Job)
- Abb Vie (1 Job)
- Dr. Falk Pharma GmbH (1 Job)
- HELM AG (1 Job)
In welchen Bundesländern werden die meisten Regulatory Medical Writer Jobs angeboten?
Die meisten Stellenanzeigen für Regulatory Medical Writer Jobs werden derzeit in Hessen (4 Jobs), Niedersachsen (2 Jobs) und Bayern (2 Jobs) angeboten.
