Regulatory Affairs Writer Stellenangebote

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Job gestern gefunden

Sr. Medical Science Liaison- Emea

• Vaud The Global Medical Sciences Liaison liaises with the international (OUS) healthcare and scientific communities to support the market introduction and/ or sustainment of Tandems products,[...]

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[...] market penetration. This role strengthens the development of the companys relationship with the medical/ scientific community by communicating product- related information to investigators and institutions and by assisting field reps and distributor partners with medical- related questions which require Medical Affairs oversight. Works closely with the Medical Writer and Medical Affairs team to write up medical evidence for OUS regulatory findings and facilitate research and analyses necessary for OUS market access. Partners closely with the International Clinical Team, as well [...]

Job vor 3 Tagen gefunden Clinical Evaluation Manager/ Medical Writer Manager (m/f/d) Join us today and make a difference in peoples lives Clinical Evaluation Manager/ Medical Writer Manager (m/f/d) Essential Job Functions Ensure completion of clinical evaluation[...]

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Join us today and make a difference in peoples lives Clinical Evaluation Manager/ Medical Writer Manager (m/f/d) Essential Job Functions Ensure completion of clinical evaluation plans (CEP) and reports (CER) and Post Market Clinical Follow- [...] all main internal and external stakeholders within the agreed timelines Perform ad hoc and systematic literature reviews on global scientific newly released data to support Product Market Surveillance reports, Global Signal Detection meetings, Study Design Protocols, Global Market Value Dossiers, Regulatory Dossiers, Medical Affairs scientific summary documents Provide writing skills to protocols and clinical study reports and all relevant clinical documentation (literature review plans/ [...]

Job vom 08.03.2025

Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/ Germany/ Hungary)

• Köln, Düsseldorf, Dortmund, Nordrhein- Westfalen Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/ Germany/ Hungary) Updated: March 3, 2025 Location: Germany- Europe- DEU- Home- Based Job ID: 25001934 Syneos[...]

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Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/ Germany/ Hungary) Updated: March 3, 2025 Location: Germany- Europe- DEU- Home- Based Job ID: 25001934 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 modern market realities. Our Clinical Development model brings the customer and the patient [...]
Alle Spain Stellenangebote anzeigen

Job vom 02.03.2025 Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/ Germany/ Hungary) Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/ Germany/ Hungary) Updated: February 21, 2025 Location: Germany- Europe- DEU- Home- Based Job ID: 25001934 Syneos[...]

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Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/ Germany/ Hungary) Updated: February 21, 2025 Location: Germany- Europe- DEU- Home- Based Job ID: 25001934 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 modern market realities. Our Clinical Development model brings the customer and the patient [...]

Job vom 02.03.2025

Head of Medical Writing (m/f/d)

• Hechingen, Baden- Württemberg Führungs-/ Leitungspositionen Its a good feeling to know youre doing your best with purpose every day. At Artivion, we manufacture high- quality products and solutions for the[...]

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[...] a contribution to saving lives together with us. Contribute your strengths and let us grow together. We are hiring Head of Medical Writing (m/f/d) Your Strength 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 [...] maximize writers contributions and career development Familiarity with medical devices, MDD and MDR Accomplished use of MS Word, Power Point and Adobe Acrobat Proficiency in written and spoken English Practice in managing medical writers preferred. Your Contribution Establish medical and regulatory writing best practices (templates, SOPs, work instructions, document review, document timelines) to ensure consistency and quality of documents Lead writing team to ensure the generation of key documents in internal clinical partnerships with relevant functions (Project Management, Data Managements and CRAs) on schedule and the support of key documents in Artivion partnerships with relevant functions (Regulatory Affairs, Quality, R D and Sales Marketing) Strategic and timely completion of key documents such as clinical study protocols, Clinical Study [...]
Alle Medical Writing Stellenangebote anzeigen

Job vom 02.03.2025 Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/ Germany/ Hungary) Description Senior Medical Writer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs[...]

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Description Senior Medical Writer 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 modern market realities. Our Clinical Development model brings the customer and the patient [...] arising during the writing process, including resolution or escalation as appropriate. Reviews statistical analysis plans and table/ figure/ listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team providing review [...]

Job vom 09.02.2025

Germany Public Policy and Government Relations Manager

• Berlin Germany Public Policy and Government Relations Manager Stripe is looking for a Public Policy and Government Relations Manager based in Berlin to lead our efforts[...]

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[...] part of a growing EMEA Public Policy team. Stripe is building the economic infrastructure that makes it easier for entrepreneurs and companies all over the world to grow their businesses. We work on some of the hardest technical, business, and regulatory problems around and in this role you will deal with a diverse set of matters that straddle financial services, technology [...] and the future of payments. Help colleagues across Stripe understand potential policy developments and identify policy opportunities to grow our business and products. We are looking for someone who has: At least 8+ years of experience working in a legislative affairs or similar government position, or similar experience at a public policy firm, world class in- house government relations organization or [...] acumen an understanding of internet technologies and the financial services and payments industry. A track record of excellent judgment, capable of making smart decisions in the face of ambiguity and imperfect information and learning from them. A terrific communicator and writer, adept at working with lawyers, regulators, engineers, business teams, and colleagues to make complex concepts clear and understandable. Passionate about [...]
Alle Government Relations Manager Stellenangebote anzeigen

Job vom 02.02.2025 Clinical Evaluation Manager/ Medical Writer Manager (m/f/d) • München, Bayern Join us today and make a difference in peoples lives Clinical Evaluation Manager/ Medical Writer Manager (m/f/d) Essential Job Functions Ensure completion of clinical evaluation[...]

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Join us today and make a difference in peoples lives Clinical Evaluation Manager/ Medical Writer Manager (m/f/d) Essential Job Functions Ensure completion of clinical evaluation plans (CEP) and reports (CER) and Post Market Clinical Follow- [...] all main internal and external stakeholders within the agreed timelines. Perform ad hoc and systematic literature reviews on global scientific newly released data to support Product Market Surveillance reports, Global Signal Detection meetings, Study Design Protocols, Global Market Value Dossiers, Regulatory Dossiers, Medical Affairs scientific summary documents. Provide writing skills to protocols and clinical study reports and all relevant clinical documentation (literature review plans/ [...]

Job vom 07.11.2024

Technical Writer Medical Devices (m/f/d)

Betriebliche Altersvorsorge 30+ Urlaubstage 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[...]

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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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Kaufmännische Tätigkeiten Regulatory Affairs & Management

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