Job description we are seeking a highly skilled medical writer – regulatory affairs senior officer to join our team of development, strategy and scientific writing experts. as a key member of our unit, you will play a crucial role in shaping the regulatory landscape for our pharmaceutical projects. main responsibilities: 1. develop high-quality regulatory documents to support drug development, including sa, pip, odd, impd, and ib. 2. create ectd dossier clinical and nonclinical documents (m2). 3. contribute to regulatory strategy for maa submissions. 4. manage client relationships, defining milestones, planning, and executing tasks, managing timelines, and project reporting. 5. serve as liaison with health authorities for drug development procedures. 6. submit and manage applications through portals such as ctis and iris. requirements: 1. hold a scientific or biomedical background. 2. possess a minimum of 4 years' experience in a similar role, working in regulatory writing within the pharma sector, or spin-off/start-up. 3. demonstrate strong knowledge of regulatory affairs. 4. excel in client-oriented communication skills and proactive mindset. 5. exhibit advanced proficiency in it tools (ms office suite). 6. languages: fluency in english (c1 or higher) is mandatory; spanish is a significant advantage. why work at asphalion? 1. pursue a permanent contract. 2. benefit from home office and hybrid or remote model flexibility. 3. engage in a wide variety of projects, new challenges, and experiences. 4. participate in a comprehensive training and personal development...
Job overview asphalion invites applications for the position of medical writer – regulatory affairs senior officer, joining our dynamic team of experts in development, strategy, and scientific writing. as a senior writer, you will be instrumental in creating and implementing regulatory strategies for our pharmaceutical projects. main responsibilities: 1. create high-quality regulatory documents for drug development, including sa, pip, odd, impd, and ib. 2. develop ectd dossier clinical and nonclinical documents (m2). 3. design regulatory roadmaps to guide project success. 4. collaborate in regulatory strategy for maa submissions. 5. build strong relationships with clients, establishing milestones, planning, and executing tasks, managing timelines, and project reporting. 6. act as liaison between health authorities and our company for drug development procedures. 7. submit and manage applications through various portals, such as ctis and iris. key requirements: 1. scientific or biomedical educational background. 2. minimum 4 years of experience in regulatory writing within the pharma sector or equivalent fields. 3. strong understanding of regulatory affairs. 4. excellent client-orientation and proactive approach. 5. proficiency in ms office suite. 6. language: english c1 level or higher, with spanish being advantageous....
We are looking for a medical writer – regulatory affairs senior officer for our team of development, strategy and scientific writing expert unit. someone who loves science and wants to use their experience in a new challenging professional step. main responsibilities: writing regulatory documents to support drug development (sa, pip, odd, impd, ib) writing ectd dossier clinical / nonclinical documents (m2) design of regulatory roadmaps regulatory strategy for maa client and partner management: define milestones, planning and execution of tasks, manage timelines, project reporting liaison with health authorities for drug development procedures submission and management of applications through portals (ctis, iris, ...) requirements: educational background: scientific / biomedical background experience: minimum of 4 years in a similar role working in regulatory writing in pharma sector, or spin-off / start up skills and competencies: strong knowledge of regulatory affairs. excellent client-oriented communication skills and proactive mindset. advanced proficiency in it tools (ms office suite). languages: fluency in english (c1 or higher) is mandatory; spanish is a significant advantage. why work at asphalion? permanent contract. homeoffice & hybrid or remote model (you can be located anywhere in spain!) wide variety of projects, new challenges and experiences. training and personal development program. #j-18808-ljbffr...
Cree una alerta de empleo y reciba nuevas ofertas que se adaptan a su perfil desde más de 2550 sitios web de empleo