Principal Medical Writer: Drive Global Regulatory Submissions

Syneos Health, Inc. is seeking a Principal Medical Writer to lead sponsor-dedicated medical writing across studies.You will manage complex deliverables, define document strategy, and coordinate activities with cross-functional teams.The role requires at least 6 years in medical writing, strong knowledge of FDA/ICH guidance, and the ability to mentor junior...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale.Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer.We provide our teams with the resources needed to...

As a Principal Medical Writer, you will lead high-quality scientific documents to support regulatory submissions and publications.You collaborate with clinical, regulatory, and medical affairs teams to translate data into clear narratives.The role is on-site in a collaborative environment that values expertise and innovation.You will shape scientific...

RA Principal Associate (M/F/X)Tasks:Lead and execute regulatory strategies for assigned products and projects.Prepare, compile, and submit high-quality regulatory applications, including variations, renewals, and responses to health authority questions.Ensure regulatory dossiers remain compliant and up to date for EU, UK, and Switzerland markets.Provide...

ResponsibilitiesConduct medical review of clinical trial and post-marketing safety data, including adverse events (AEs), adverse drug reactions (ADRs), coding, causality, expectedness, seriousness assessments, and benefit-risk evaluations.Provide medical oversight and review of safety documentation, including narratives, aggregate reports, annual and...

OverviewIn this role, you will lead the industrialization, validation and lifecycle management of Device Constituent Parts and device platforms, ensuring scalable, compliant development and technology transfer. You will drive cross-functional alignment across R&D, Quality, Regulatory, Manufacturing, and external partners to secure regulatory compliance and...

Altro cerca un Principal Medical Writer per guidare la redazione di documenti scientifici per sottomissioni regolatorie e pubblicazioni. Lavorerai a stretto contatto con team clinici, regolatori e medical affairs per trasformare i dati in narrativa chiara. Il ruolo è on-site in un ambiente collaborativo che valorizza competenze ed innovazione. Contribuirai...

Clinical Research Associate, Site Management - Italy page is loaded## Clinical Research Associate, Site Management - Italylocations: Milan, Italy: Milan, Italytime type: Full timeposted on: Posted Todayjob requisition id: R Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as...

Select how often (in days) to receive an alert:Non aspetti a candidarsi dopo aver letto questa descrizione: per questa opportunità è previsto un elevato volume di candidature.The Medical Director has a direct reporting line to the Country Manager.Its main function is to ensure that all scientific and clinical activities comply with current regulations and...