13 Jobs für Regulatory Affairs Writer
Stellenangebote Regulatory Affairs Writer Jobs
Job gestern bei Jobleads gefunden
Führungs-/ Leitungspositionen
Work-Life-Balance
A leading biopharmaceutical solutions organization in Switzerland is seeking a Senior Principal Medical
Writer to develop
regulatory documents and manage writing projects. The role involves mentoring junior writers and collaborating [...]
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[...] with cross-functional teams to deliver quality submissions. Ideal candidates will have demonstrated expertise in regulatory documentation and a solid understanding of the drug development process. The position offers competitive compensation and a range of benefits to [. .. ]
Job gestern bei Jobleads gefunden
Senior Principal Medical
Writer-Regulatory-Oncology-Single Sponsor Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical
affairs and commercial insights into [...]
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[...] outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, [. .. ]
Job vor 3 Tagen 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 Tech [...]
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[...] start-up (Cor Lector Gmb H) based in Nuremberg that develops software solutions for cardiology. Our products are about to be approved, which is [. .. ] technical documentation for MDR and FDA approvals. Structuring and editing documents such as instructions for use, risk management documents, clinical evaluations and software documentation. Working closely with the development, regulatory affairs and quality management departments. Ensuring compliance with applicable standards and regulatory requirements (e. g. ISO 13485, IEC 62304, ISO 14971) . Supporting the optimization of our documentation processes and structures. Your profile Several years of experience in technical writing, ideally in the medtech or life science environment. Profound knowledge of [. .. ]
Job vor 9 Tagen 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. [. .. ] JCA and JSC activities. Ensure alignment of EU HTA JCA and JSC timelines with regulatory milestones (e. g. , MAA) , in partnership with the GVAP portfolio lead and regulatory affairs, incl. regulatory scenario planning, final assessment scope received, changes to indication etc. Ensure close collaboration and alignment with HEOR on PICO simulation, SLR, ITC timeline, information retrieval process, study list development. Ensure timely delivery of cross-functional contributions and maintain strong version control and documentation quality. Identify key risks early, [. .. ]
Job vor 10 Tagen 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 [...]
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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. [. .. ] JCA and JSC activities. Ensure alignment of EU HTA JCA and JSC timelines with regulatory milestones (e. g. , MAA) , in partnership with the GVAP portfolio lead and regulatory affairs, incl. regulatory scenario planning, final assessment scope received, changes to indication etc. Ensure close collaboration and alignment with HEOR on PICO simulation, SLR, ITC timeline, information retrieval process, study list development. Ensure timely delivery of cross-functional contributions and maintain strong version control and documentation quality. Identify key risks early, [. .. ]
Job am 09.12.2025 bei Jobleads gefunden
• Wiesbaden, Hessen
[. .. ] Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at Follow abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok. 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 [. .. ]
Job am 05.12.2025 bei Jobleads gefunden
• Berlin
Beratungs-/ Consultingtätigkeiten Homeoffice möglich
[. .. ] of the worlds fastest growing consultancies, where entrepreneurial people thrive? Verantwortlichkeiten Your impact: A trusted client adviser : Build and maintain strong client relationships, delivering strategic counsel [...]
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[...] especially on public affairs, policy, and regulatory matters. Highly networked : Nurture a strong network with relevant stakeholders, including journalists, policy makers, analysts, and other key contacts. A source of knowledge : Develop excellent client knowledge and understanding to give concise, accurate overviews of each clients business, communications objectives, and PR and engagement strategy. Stay up to [. .. ] and wellconnected within the Berlin policy arena. Know your way around the media: were looking for someone with a keen eye for what makes a good story. Are a creative writer: youll need the skills to tell our clients stories through highquality written content. Are wellorganised: excellent attention to detail, enthusiasm, strong organisational skills, ability to multitask and work as part of a team in a fastpaced environment. Like to work internationally: in a fastpaced, highstakes environment with international crossborder teams. [. .. ]
Job am 05.12.2025 bei Jobleads gefunden
• Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] We are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at [...]
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[...] Job Function Medical Affairs Group Job Sub Function Medical Writing Job Category People Leader Job Posting Locations Allschwil Basel-Country Switzerland Job Description About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our sciencebased advancements. Visionaries like you work on teams that save lives by developing [. .. ] Requisition Number : R-039966 Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission. Purpose The Director 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 crossfunctional teams driving strategic discussions, developing internal medical writers and ensuring adherence to best practices and regulatory guidelines. The Director Reg MW has [. .. ] within the Medical Writing (MW) team in close consultation and accordance with the Delivery Unit (DU) . Head 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 highlevel and crossfunctional TA meetings and has significant independent decisionmaking authority. Can step in for DU Head in case of absence. Is a [. .. ]
Job am 22.11.2025 bei Jobleads gefunden
Director, Medical Writing, Oncology (1 of 2)
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https:/ / [...]
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[...] Job Function Medical Affairs Group Job Sub Function Medical Writing Job Category People Leader All Job Posting Locations Allschwil, Basel-Country, Switzerland Job Description About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives [. .. ] Canada-Requisition Number: R-039966 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Purpose The Director 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 crossfunctional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, Reg MW has [. .. ] 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 highlevel and crossfunctional TA meetings and has significant independent decisionmaking authority. Can step in for DU Head in case of absence. Is a [. .. ]
Job am 01.11.2025 bei Jobleads gefunden
• Hannover, Niedersachsen
Senior Scientific Communications Specialist English (Medical
Writer/ Promo Review) Location: Fully Remote Europe Essentials Degree: Advanced degree in Pharmacy (Pharm D preferred) , advanced healthcare degree, or equivalent clinical [...]
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[...] experience. Experience: 24 years in scientific content creation within the pharmaceutical industry, medical education, or academia. Languages: Fluent in English and German (C1/ C2) . Position Summary The Senior [. .. ] across multiple therapeutic areas. This role ensures the delivery of accurate, balanced, and compliant content for internal stakeholders, healthcare professionals, and consumers. The position supports client needs, aligns with Medical Affairs and brand strategies, and may lead team members or client projects. Key Responsibilities Develop, review, and edit scientific and medical materials (e. g. , standard/custom responses, slide decks, manuscripts, dossiers, and promotional materials) . Ensure content accuracy, scientific integrity, and compliance with regulatory standards. Apply and maintain approved content and style guidelines in content management systems. Respond to medical information requests via email, web, or calls; conduct scientific exchanges as needed. Participate in scientific and brand training to maintain expertise. Meet quality and turnaround targets while adhering to legal, regulatory, and compliance policies. [. .. ]
Job am 09.10.2025 bei Jobleads gefunden
Medical Science Liaison Hematology/ Oncology (m/f/d) - Rheinland-Pfalz, Saarland, Süd-Hessen, . . .
[. .. ] Job Summary Medical Science Liaisons (MSLs) are a team of field-based, highly trained professionals with strong clinical and/or scientific backgrounds and excellent communication skills. They represent the [...]
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[...] Medical Affairs organization to the broad medical/ scientific community. Essential Functions Of The Job (Key Responsibilities) Represent the company and lead medical scientific exchanges within the respective community Develop and lead Key External Experts and investigators engagement plans-identify, develop and maintain long-term collaborative relationship with External Experts and Scientific Bodies. [. .. ] on new clinical data and findings. Lead and support advisory board meetings, round table meetings and investigator meetings. Adhere to corporate SOPs and ensure vigilant compliance with relevant legal and regulatory requirements and guidelines governing scientific interactions with physicians and healthcare professionals across all activities. Share best practice experiences with fellow MSLs. Embrace and demonstrate the Incyte Corporate Values. Contribute positively to a strong culture of business integrity and ethics. Employees assigned to this job. They are not intended to be [. .. ] Clinician-Southern Germany Austria Head of MSL Innovative Oncology DACH (m/w/d) Associate Director, Field Medical Advisor (m/w/d) Associate Director, Field Medical Advisor (m/w/d) Medical Writer/ Medical Content Manager (m/w/d) Principal Biostatistician (Medical Affairs/ HEOR-EMEA and NA Based) ) Medical Science Liaison-Germany (South) Cologne, North Rhine-Westphalia, Germany 5 days ago Medical Science Liaison Manager-NRW (m/f/d) Medical Science Liaison Oncology South West Germany Medical Science Liaison, Oncology, Germany (m/[. .. ]
Job am 09.10.2025 bei Jobleads gefunden
Senior Principal Medical Writer-Regulatory-Oncology-Single Sponsor
• Zürich
Overview Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical
affairs and commercial insights into outcomes to address [...]
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[...] modern market realities. Our Clinical Development model centers the customer and the patient, with a focus on simplifying and streamlining work. We collaborate across Functional Service Provider or Full-Service environments to accelerate the delivery of therapies and change lives. WORK HERE MATTERS EVERYWHERE Job Responsibilities Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and in alignment with internal authoring standards and study/ project timelines. Manage medical writing projects, including developing timelines (in coordination with study/ project teams) and communicating with cross-functional team members to [. .. ] considered. This description does not create a contract of employment. The Company complies with applicable equal employment opportunity laws and disability accommodations where required. Headlines and Notes Senior Principal Medical Writer-Regulatory-Oncology-Single Sponsor is the role described. This listing may include additional context from the posting. If you are viewing this externally, verify the posting details with the employer. #J-18808-Ljbffr 65367998 [. .. ]
Job am 06.12.2025 bei Neuvoo gefunden
Abb Vie
Senior HTA Writer
• Wiesbaden, Hesse
Stellenbeschreibung 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 [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] 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 [. .. ]
Häufig gestellte Fragen
Wieviel verdient man als Regulatory Affairs Writer pro Jahr?
Als Regulatory Affairs Writer verdient man zwischen EUR 45.000,- bis EUR 65.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Regulatory Affairs Writer Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 13 offene Stellenanzeigen für Regulatory Affairs Writer Jobs.
In welchen Bundesländern werden die meisten Regulatory Affairs Writer Jobs angeboten?
Die meisten Stellenanzeigen für Regulatory Affairs Writer Jobs werden derzeit in Hessen (3 Jobs), Sachsen-Anhalt (2 Jobs) und Niedersachsen (1 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Affairs Writer Jobs?
Regulatory Affairs Writer Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
