Regulatory Affairs Writer Stellenangebote

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Stellenangebote Regulatory Affairs Writer Jobs bei Jobleads

Job vom 11.10.2024

Lead Medical Writer (Reporting to Vice President Regulatory Affairs)

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

Your mission As a Lead Medical Writer, you will plan, author, and organize the review process of documents pertaining to clinical studies and regulatory interactions, including (but not limited to) critical sections of marketing applications, protocols, clinical study reports, briefing documents, and responses to [...] the organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/ grammar. The Lead Medical Writer, based in the UK, Germany, or France (remote position) , will report to the Vice President of Regulatory Affairs. Responsibilities Preparation of regulatory documents for the purpose of NDA/ MAA/ IND submissions as well as briefing packages in accordance [...]
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Stellenangebote Regulatory Affairs Writer Jobs bei StepStone

Job vom 17.08.2024 JOTEC GmbH

Head of Medical Writing (m/f/d)

• Hechingen Führungs-/ Leitungspositionen Homeoffice möglich

MEHR

Arzt Humanmediziner Mediziner Medizinerin Facharzt Fachärztin Chemiker Chemieingenieur Naturwissenschaftler Regulatory Affairs Biologe Biochemiker Molekularbiologe Mikrobiologe Pharmazeut Pharmakologe Arzneimittelzulassung Doctor physician medic health professional medical scientist chemnist chemical engineer medicine pharmaceutica . [...] preparation for document reviews in an efficient manner Oversight of medical and regulatory writing vendors in alignment with global internal resources, methods, SOPs, and overall approach Degree in medicine or natural science Long- standing years of experience as a medical writer in the medical/ biomedical industry with evidence of increasing responsibility and technical development Proficient at writing protocols, manuscripts and study [...]
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Weitere Stellenangebote Regulatory Affairs Writer bei Jobleads

Job vor 8 Tagen gefunden

Director, Regulatory Medical Writing (1 of 4)

Führungs-/ Leitungspositionen

MEHR

Description Johnson Johnson is currently seeking a Director, Regulatory Medical Writing. The primary location for this position is the United States. Secondary locations are Canada, United Kingdom, Switzerland, Netherlands, [...] This is a global role and is open to other countries. Remote work options may be considered on a case- by- case basis and if approved by the company. The Director, Regulatory Medical Writing (RegMW) is a highly experienced medical writer and influential leader with strategic responsibilities as it relates to the delivery of high- quality regulatory documentation. This position will [...]
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Job vor 14 Tagen gefunden

Technical Writer Medical Devices (m/f/d)

Betriebliche Altersvorsorge 30+ Urlaubstage

MEHR

Please note that this job offer is only available in German. Zur Verstärkung unseres Qualitätsmanagements am Hauptstandort in Altlußheim suchen wir ab sofort Technical Writer Medizinprodukte (m/w/d) IFUs sind für die Einhaltung regulatorischer Anforderungen von entscheidender Bedeutung. Die Dokumente liefern wichtige Informationen darüber, wie ein [...] uns: Schreiben und Pflege von Gebrauchsanweisungen (IFUs) für unsere Software- und Systemprodukte Erstellung und Überarbeitung von IFUs und eIFUs (z. B. Quick Guides) für verschiedene Länder/ Regionen Sicherstellung der Einhaltung von IVDR- und MDSAP- Vorschriften in Zusammenarbeit mit der Abteilung Regulatory Affairs Mitarbeit im Risikomanagement- Team zur Erstellung oder Überprüfung von Risikobewertungen und Umsetzung von Risikominimierungen in den IFUs Das bringen Sie [...]

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Stellenangebote Regulatory Affairs Writer Jobs bei jobDENTAL

Job vom 28.09.2024 Geistlich Biomaterials Vertriebsgesellschaft mbH

Clinical Science Education Manager (m/w/d) in Baden Baden

• 76534 Baden- Baden Homeoffice möglich Firmenwagen Flexible Arbeitszeiten

MEHR

[...] medizinischen und wissenschaftlichen Themen und bereiten zielgruppengerechte Trainingsmodule vor Mit unserem Headquarter in der Schweiz arbeiten Sie in engem Informationsaustausch zusammen Sie informieren Fachkreise zu Eigenschaften und Anwendung unserer Produkte Sie unterstützen in der Funktion als PRRC (Person Responsible for Regulatory Compliance) Geistlich Biomaterials in der Aufgabe als Authorized Representative (EU Rep) Sie sind Teil des lokalen Leadershipteams Ihr Profil Universitätsabschluss mit einem naturwissenschaftlichen oder zahnmedizinischen Hintergrund Sie haben mind. 1- 2 Jahre Berufserfahrung im Vertrieb, Marketing, Regulatory oder in der klinischen Wissenschaft im Gesundheitswesen (Scientific Affairs, Medical Affairs, Scientific writer) Sie sind ein Teamplayer und schätzen die abteilungsübergreifende, interdisziplinäre Zusammenarbeit Sie Überzeugen durch Verbindlichkeit und Auftreten und können komplexe Themen [...]
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Stellenangebote Regulatory Affairs Writer Jobs bei NewScientist Jobs

Job vor 6 Tagen gefunden Bio Marin Pharmaceutical Inc.

Associate Medical Director, Clinical Science

• London, Greater London, United Kingdom, London (Greater) Führungs-/ Leitungspositionen

MEHR

[...] monitoring. SUMMARY DESCRIPTION The Associate Director/ Associate Medical Director is an emerging leadership position within Clinical Science. S/ he leads tasks related to Clinical Science core deliverables across all stages of program and study design and execution, data analysis and regulatory filings as delegated by the Clinical Science Therapeutic area lead or other Clinical Science leader. This includes developing key documents [...] Statistical Analysis Plans (SAPs) Help define study quality metrics and perform study data reviews during study execution to ensure integrity of accruing study data Clinical Science Communication and Collaboration Serve as CLS representative and liaise with Pharmacovigilance, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Data Monitoring Committees (DMCs) and other internal or external entities as needed Clinical Study Monitoring Act as [...] review, review of blinded tables, listings and figures (TLFs) , etc. ) and actively participate in all data snapshots taken (not limited to final DBL) Contribute to and review Clinical Study Report (CSR) writing (review final TLFs, work with medical writer to review revise CSR document, draft discussion and conclusions, participate in comment resolution meetings) Present study updates and topline results [...]

Job vom 27.10.2024 Rx Logix Corporation

Content Writer- Pharmacovigilance

• London, United Kingdom, London (Greater)

MEHR

[...] s PV Surveillance Suite Platform to replace its legacy FAERS signaling system, utilizing our modules for advanced data analytics, signal detection, evaluation, signal management, and benefit- risk assessment. Job Description: We re on the hunt for a dynamic, creative Content Writer with a solid background in pharmacovigilance. This role calls for a strategic thinker who can understand our product offerings and [...] impactful. Work closely with product managers, sales, and marketing teams to understand product features, benefits, and use cases, and translate them into compelling content. Key Qualifications: Education: Bachelor s degree in Pharmacovigilance, Life Sciences, Pharmacy, Medicine, or a related field. Regulatory and Compliance: Strong understanding of pharmacovigilance principles, drug safety regulations, and industry guidelines. Knowledge of regulatory requirements for drug safety [...] databases and reporting systems. Content Development and Communication: Experience in pharmaceutical or healthcare communications. Capability to develop educational materials and proficiency in authoring and communicating pharmacovigilance communication strategies. Collaboration and Teamwork: Ability to collaborate with pharmacovigilance experts, medical writers, regulatory affairs professionals, and other stakeholders. Experience in participating in cross- functional teams to support pharmacovigilance initiatives and projects. Location: Hybrid, London, [...]

Job vom 26.10.2024 Richmond Pharmacology

Principal Medical Writer

• London, United Kingdom, London (Greater)

MEHR

Job Title: Principal Medical Writer Location: London Bridge (Hybrid 4 Days onsite) Term: Permanent, Full- time Salary: Competitive Salary + Benefits (Private Medical, Private Dental, [...] commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life- changing therapies. The Role: We are seeking an experienced and accomplished Principal Medical Writer to lead and develop our medical writing and regulatory teams. In this senior role, you will play a pivotal part in overseeing the preparation of high- quality regulatory submissions and medical writing deliverables, ensuring clarity, accuracy and compliance with regulatory standards. You will serve as a key advisor to both internal teams and external sponsors, providing strategic guidance on regulatory affairs and medical writing. As a leader, you will manage the entire medical writing and regulatory submissions process, liaising directly with [...]

Job vom 12.10.2024 Costello Medical

Analyst/ Medical Writer

• Cambridge, United Kingdom, Cambridgeshire

MEHR

[...] knowledge of economics is required (though there is considerable opportunity to develop knowledge of health economics in the role) , but good numerical skills, the ability to critically appraise clinical evidence and strategic thinking are key to the role Medical Affairs. Medical Affairs provides the scientific bridge between clinical development and commercial functions in pharmaceutical and device companies. Most activities have [...] This includes the development of abstracts and manuscripts, as well as posters and oral presentations for large international congresses, with the opportunity to provide on- site support at such events. In addition, you may have the chance to work on regulatory documents, plain language summaries and policy- related publications. You will receive one- to- one training on the technical aspects of [...] Career Profile We offer many opportunities for personal and professional development at Costello Medical. Please click below to read firsthand accounts from our colleagues about their time with the company: A Day in the Life of an Analyst or Medical Writer Our colleagues in the Analyst and Medical Writer roles have shared their experiences of their day to day lives at [...]
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Kaufmännische Tätigkeiten Regulatory Affairs & Management

Dauer: 0,5234 s., Vers. V.2025-a-2005-Ind