Medical Writer Senior
il y a 3 jours
ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions. Since almost 30 years, ProductLife Group (PLG) supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 130 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics. With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.PLG is a fast-growing organization, evolving from €25m revenue in 2020 to €210m in 2024, and with an ambition to reach €600m by 2028. The development being supported by a continued M&A strategy (23 build-ups closed since 2020).ResponsibilitiesAnalysis of data and preparation of ad hoc reports/plans in the framework such as: risk management, benefit/risk ratio, signals.Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical analysis.Production and validation of safety reports (written by this division or by the Case Management Business Unit) depending on seniority and after successful experience in writing Medical training for staff from other divisions.Participation in the drafting of quality documents related to the Medical writing specific activities (i.e., Standard Operating procedures (SOPs) and Working Practice Documents).Act as a Pharmacovigilance Responsible Person for France for selected clients.Leading and managing Safety Writing (PSUR/PBRER/ACO/CES/DSUR/SIGNAL DETECTION).Coordinating with various internal and external stakeholders, including MAH and ‘exploitants’.Ensuring compliance with safety and quality standards.Reporting on project progress and performance.ProfileEducation : Pharmacist, Physician residing in France (French PV regulatory requirement).Experience :At least 7 years’ experience in PV activities / especially in safety writing.Acted at least as deputy QPPV and/or RPV.Having worked with multiple clients, different PV system for minimum of 7 years. Direct participation in inspections from the health authorities.Languages : French and English.Technical skills :Extensive experience in PV and in-depth knowledge of health and safety regulations (GVP and BPPV).Knowledge of case management at least.Good safety writing skills (drafting, quality control and medical review).Proficiency in safety databases software.Adept in using MS Office tools and Pharmacovigilance tools.Knowledge of the Customer’s products and services.Experience in audits and inspections.Strong leadership and team management skills would be an asset.Rigor, reliability, and accountability.Effective communication.Time and priorities management.Excellent organizational and multitasking abilities. #J-18808-Ljbffr
-
Senior Medical Writer
il y a 3 jours
Paris, France Excelya Temps pleinSenior Medical Writer Join to apply for the Senior Medical Writer role at Excelya. As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects and work alongside industry experts to...
-
Senior Medical Writer
il y a 1 semaine
Paris, France Excelya Temps plein**Why Join Us?** At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact. As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's **leading mid-size CRO**, delivering the **best employee experience**. Our...
-
Senior Medical Writer
il y a 3 jours
Paris, France ICON Temps pleinSenior Medical Writer ICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Medical Writer to join our diverse and...
-
Principal Medical Writer
il y a 3 jours
Paris, France ICON Temps pleinPrincipal Medical Writer ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking Senior or Principal Medical Writer to join our...
-
Senior Medical Writer
il y a 3 jours
Paris, France Barrington James Temps pleinA fast-growing global AI company is seeking an experienced Medical Writer with a background in pharmacovigilance to join their innovative team. This hands-on role focuses on leveraging AI and automation to streamline regulatory document creation while maintaining the highest quality standards. Key Responsibilities Develop and maintain templates and content...
-
Senior Medical Writer — Clinical PK/PD
il y a 3 jours
Paris, France ICON Temps pleinA global healthcare research organization seeks a Senior Medical Writer to enhance clinical research documentation. This role involves developing high-quality documents such as Clinical Study Reports and protocols while ensuring compliance with regulatory standards. Candidates should have an advanced degree in Life Sciences, alongside 3-5 years of medical...
-
Principal Medical Writer
il y a 6 jours
Paris, Île-de-France ICON plc Temps pleinPrincipal Medical WriterICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking Senior or Principal Medical Writer to join our...
-
Senior/Principal Medical Writer
il y a 3 jours
Paris, France Parexel Temps pleinWhen our values align, there's no limit to what we can achieve.Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. We believe in our values,Parexel are recruiting for either a within our groupThe FSP...
-
Senior Technical Writer
il y a 3 jours
Paris, France Kong Inc. Temps pleinSenior Technical Writer Kong is building the future of API management for developers. We’re a fast‑growing, well‑funded company with happy customers and motivated employees. Join our friendly, fast‑moving Docs team in delivering content that helps our users succeed in their goals. We own the full docs stack, from the foundational platform, through...
-
Senior Medical Writer — Clinical Documentation Leader
il y a 3 jours
Paris, France Parexel Temps pleinA global biopharmaceutical services company is seeking a Medical Writer to support clinical documentation and regulatory submissions. The ideal candidate should have a Bachelor's in Life Sciences, significant experience in medical writing, and strong interpersonal skills. This role involves authoring Clinical Study Reports, managing documentation quality,...
