10 Jobs für Regulatory Documentation Writer
Stellenangebote Regulatory Documentation Writer Jobs
Job vor 11 Tagen bei Jooble gefunden
Biontech
• Mainz
Führungs-/ Leitungspositionen
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 of high-quality scientific and [...]
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[...] regulatory documents. Your contributions will directly impact the development and approval of novel therapeutic agents, supporting Bio NTech s efforts to address diseases with high medical needs. Collaborating within a dynamic and innovative environment, you will work closely with cross-functional teams to maintain excellence in scientific communication. You will join a workplace that values diversity, creativity, and professional growth while contributing to projects that improve global health outcomes. This role is central to shaping the documentation standards for groundbreaking therapies, allowing you to make a meaningful difference in science and medicine. Your Contribution: With limited supervision/ guidance:-Write, edit, and format a wide range of documents (of low to high complexity) required for research, non-clinical, clinical development, and post-approval life cycle management largely according [. .. ] knowledge in immunology and oncology. 5 years (hands-on) experience:-working in drug development in a therapeutically relevant field, preferably in oncology and/or immunology. as a scientific or medical writer in the pharmaceutical/ biotech industry. Prior experience:-drafting documents for multiple indications, preferably in Bio NTech-relevant indications. drafting alone new or updated CTPs and CSRs required for Phase I-III trials. drafting low to medium complexity variants of the following (new or updated variants) : IBs, clinical CTD modules, DSURs/ [. .. ]
Neu Job vor 5 Std. bei Jobleads gefunden
• Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] applications will be considered as a single submission. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose The Director [...]
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[...] of Regulatory Medical Writing (Reg MW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs) . This role is a primary liaison with cross-functional teams driving strategic discussions developing internal medical writers and ensuring adherence to best practices and regulatory guidelines. The Director Reg MW [. .. ] within the Medical Writing (MW) team in close consultation and accordance with the Delivery Unit (DU) Head and in line with R D priorities and TA objectives. Recognized expert medical writer for any document within and across TAs. Accountable for MW resource management and allocation within their portfolio (s) . Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. Can step in for DU Head in case of [. .. ] operational leadership to medical writing teams across all levels with responsibility for setting vision driving functional excellence mentoring leaders and ensuring the successful delivery of highquality compliant clinical and regulatory documentation across the portfolio. Expertise in project management and process improvement is required. Strong decision-making skills strategic thinking agility broad vision is required. Other Excellent oral and written communication skills. Attention to detail. Expert time management for self direct reports (if applicable) and teams. Ability to delegate responsibility to other [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] applications will be considered as a single submission. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose The Director [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] of Regulatory Medical Writing (Reg MW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs) . This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, Reg MW [. .. ] within the Medical Writing team, in close consultation and accordance with the Delivery Unit (DU) , head and in line with R D priorities and TA objectives. Recognized expert medical writer for any document within and across TAs. Accountable for MW resource management and allocation within their portfolio (s) . Represent MW DU Head or department at high-level and cross-functional TA meetings with significant independent decision-making authority, and can step in for DU Head in case of absence. [. .. ] leadership to medical writing teams across all levels, with responsibility for setting vision, driving functional excellence, mentoring leaders, and ensuring the successful delivery of high-quality, compliant clinical and regulatory documentation across the portfolio. Expertise in project management and process improvement is required. Strong decision-making skills, strategic thinking, agility, broad vision is required. Other Excellent oral and written communication skills. Attention to detail. Expert time management for self, direct reports (if applicable) , and teams. Ability to delegate responsibility to [. .. ]
Job vor 8 Tagen bei Jobleads gefunden
Associate Director Scientific/ Medical Writing
• Mainz, Rheinland- Pfalz
Führungs-/ Leitungspositionen
[. .. ] 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 of [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] high-quality 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 cross-functional teams to maintain excellence in scientific communication. You will join a workplace that values diversity, creativity, and professional growth while contributing to projects that improve global health outcomes. This role is central to shaping the documentation standards for groundbreaking therapies, allowing you to make a meaningful difference in science and medicine. Your Contribution With limited supervision/ guidance: Write, edit, and format a wide range of documents (of low to high complexity) required for research, non-clinical, clinical development, and post-approval life cycle management largely according [. .. ] knowledge in immunology and oncology. 5 years (hands-on) experience: working in drug development in a therapeutically relevant field, preferably in oncology and/or immunology. as a scientific or medical writer in the pharmaceutical/ biotech industry. Prior experience: drafting documents for multiple indications, preferably in Bio NTech-relevant indications. drafting alone new or updated CTPs and CSRs required for Phase I-III trials. drafting low to medium complexity variants of the following (new or updated variants) : IBs, clinical CTD modules, DSURs/ [. .. ]
Job am 23.01.2026 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 am 11.01.2026 bei Jobleads gefunden
• München, Bayern
Direct message the job poster from i O Associates Senior Consultant Partnering with Businesses in Germany Switzerland Technical
Writer-S1000D (m/f/d) Permanent Full-time Germany-wide We are seeking Technical Writers with [...]
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[...] strong S1000D exposure to support complex, safety-critical engineering programmes. This role is ideal for professionals who enjoy working close to engineering, translating technical data into structured, compliant documentation for end users and maintainers. Responsibilities Creation, authoring, and maintenance of technical documentation in accordance with ASD S1000D Working with data modules, business rules, and document structures within S1000D environments Independent on-site analysis and information gathering at customer or project locations Interpretation of engineering drawings, CAD models (2d/3D) , parts lists, and technical specifications Creation and optimisation of illustrations and graphics to explain complex technical systems Ensuring documentation compliance with quality, configuration, and regulatory requirements Close collaboration with engineering, logistics, and project stakeholders Required Qualifications Experience Technical education, state-certified technician, or engineering degree Proven experience as a Technical Writer in an S1000D environment Background in aerospace, defence, or naval systems is highly desirable Understanding of S1000D concepts such as: Applicability and business rules; [. .. ]
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 Med [...]
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[...] 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 why [. .. ]
Job am 28.10.2025 bei Jobleads gefunden
Director, Medical Writing, Oncology
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] applications will be considered as a single submission. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose: The Director [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] of Regulatory Medical Writing (Reg MW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs) . This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, Reg MW [. .. ] within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU) Head and in line with R D priorities and TA objectives. Recognized expert medical writer for any document within and across TAs. Accountable for MW resource management and allocation within their portfolio (s) . Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. Can step in for DU Head in case of [. .. ] operational leadership to medical writing teams across all levels, with responsibility for setting vision, driving functional excellence, mentoring leaders, and ensuring the successful delivery of highquality, compliant clinical and regulatory documentation across the portfolio. Expertise in project management and process improvement is required. Strong decision-making skills, strategic thinking, agility, broad vision is required. Other: Excellent oral and written communication skills. Attention to detail. Expert time management for self, direct reports (if applicable) , and teams. Ability to delegate responsibility to [. .. ]
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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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
[. .. ] 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 [. .. ]
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 Hessen (1 Jobs), Sachsen-Anhalt (1 Jobs) und Bayern (1 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Documentation Writer Jobs?
Regulatory Documentation Writer Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
