11 Jobs für Regulatory Affairs Writer
Stellenangebote Regulatory Affairs Writer Jobs
Job am 11.03.2026 bei Jobleads gefunden
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] 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 merit. [...]
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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, 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 About [. .. ] 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 [. .. ]
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Job am 09.03.2026 bei Jobleads gefunden
• Freiburg im Breisgau, Baden- Württemberg
[. .. ] well as patient health and well-being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for: Global [...]
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[...] Medical Scientific Writer-70 part-time (m/f/d) . 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 [. .. ] Analyzing trial data with as part of a multidisciplinary team Providing writing support for other trial-related communications Working within and guiding cross-functional teams from clinical development to medical affairs in order to bring safe and effective medicines to patients Improving processes to standardize communication of clinical trial data Benefits Supportive, respectful and appreciative work atmosphere in a small, dedicated team Diverse learning culture and individual development opportunities International and growing family business with short decision-making processes, financial independence [. .. ]
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Job am 09.03.2026 bei Jobleads gefunden
A leading healthcare consultancy is seeking an Experienced Medical
Writer for the
Regulatory Affairs team in Austria. The successful candidate will develop and review high-quality regulatory documents, ensuring scientific accuracy [...]
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[...] and strategic alignment. Required qualifications include a Ph D in Life Sciences or MD and at least 3 years of related experience. This role offers the chance to engage with clients and contribute to [. .. ]
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Job am 09.03.2026 bei Jobleads gefunden
Experienced Medical
Writer Regulatory Affairs Austria Location: Austria We are looking for a highly motivated and experienced Medical Writer to join a dynamic Regulatory Affairs team. In this role, you [...]
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[...] will lead the development and review of high-quality, evidence-based regulatory documents supporting a wide range of projects. You will work closely with clients [. .. ]
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Job am 08.03.2026 bei Jobleads gefunden
Associate Director, Regulatory Medical Writing, Oncology
• Allschwil, Basel- Landschaft
Führungs-/ Leitungspositionen
[. .. ] 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 merit. [...]
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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 [. .. ] pioneering the path from lab to life while championing patients every step of the way. Learn more at https:/ / We are searching for the best talent for Associate Director, Regulatory Medical Writing, Oncology. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country (s) that align with [. .. ] considered as a single submission. 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 22.02.2026 bei Jobleads gefunden
Senior Medical Writer
• Berlin
[. .. ] empowered to find creative solutions and make a meaningful impact on clinical development across rare disease, oncology, neurology, immunology and inflammation. About the Role We are seeking [...]
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[...] a Senior Medical Writer to join our Medical Writing and Pharmacovigilance Team and take ownership of clinical, regulatory and safety writing projects. This is a fulltime, hybrid role reporting to the Head of Medical Writing and Pharmacovigilance, with one to two days per week based in our Berlin office. Key Responsibilities Prepare a wide range of documents for global submission across all phases of clinical development and postmarketing, [. .. ] edit documents such as clinical study protocols and reports, clinical overviews and summaries, Investigators Brochures, aggregate safety reports and Risk Management Plans. Collaborate closely with crossfunctional teams, including pharmacovigilance, regulatory affairs and clinical development, to ensure documents are accurate and submissionready. Review complex documents for consistency, scientific accuracy and alignment with client standards and regulatory requirements (e. g. , ICH, GVP, MDR) . Manage review cycles and project timelines in coordination with clients and internal stakeholders to meet delivery milestones. Act [. .. ]
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Job am 02.02.2026 bei Jobleads gefunden
• 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
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 [. .. ] 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 [. .. ]
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Neu Job vor 4 Std. bei Neuvoo gefunden
Excelya
Freiberuflich
[. .. ] to become Europes leading mid-size CRO, offering the best employee experience. Now, were calling on curious minds and courageous spirits to step into a career-defining role in [...]
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[...] Medical Affairs. Ready to make an impact that travels the globe? Lets talk. About the Job We are seeking a Freelancer Senior Medical Writer, experienced with medical devices, for a part-time fully remote role, to provide medical and scientific expertise required for the successful completion of Excelyas projects. Your Mission: Lead the preparation and review of key medical device documentation, including PMCF plans/ reports, PSURs, CERs, and PMS reports for class IIA, IIB and III medical devices. Conduct comprehensive literature searches and critically appraise scientific data to support regulatory and clinical documentation. Provide expert medical and scientific input across projects, ensuring compliance with MDR requirements and supporting transitions from MDD to MDR. Respond to regulatory authority queries with clear, evidencebased medical justifications. Collaborate with crossfunctional teams to support studyrelated documentation (protocols, study reports) for medical device projects. Participate in [. .. ]
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Job vor 11 Tagen 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 [. .. ]
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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
[. .. ] 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 [...]
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[...] 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 [. .. ] Analyzing trial data with as part of a multidisciplinary team Providing writing support for other trial-related communications Working within and guiding cross-functional teams from clinical development to medical affairs in order to bring safe and effective medicines to patients Improving processes to standardize communication of clinical trial data Your qualification University degree in a biomedical field Track record of authoring or providing writing assistance for scientific publications in peer-reviewed journals Experience in clinical research, including knowledge of ICH [. .. ]
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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 11 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 (2 Jobs), Niedersachsen (2 Jobs) und Baden-Württemberg (2 Jobs) angeboten.
Zu welchem Berufsfeld gehören Regulatory Affairs Writer Jobs?
Regulatory Affairs Writer Jobs gehören zum Berufsfeld Regulatory Affairs & Management.