![]() acting as document management system contact for the organization taking ownership over our Document Management system, which is part of our QMS.drafting and updating of SmPC’s, USPIs and patient leaflets performing literature searches and reviews as necessary incl.focusing on document management by ensuring that all legacy documents are available or requested from third parties and you actively contribute to making AM-Pharma filing-ready regarding document availability.managing quality, accuracy and compliance of regulatory and clinical documents with internal and external standards.taking responsibility for writing, editing and reviewing regulatory and clinical documents in English including IB updates, SA briefing documents, module 2 clinical (and non-clinical) documents, informed consent, study protocol, clinical study reports, SAP review, answers to HA questions).As Regulatory Medical Writer, you support our global drug development and registration activities by ![]() We have also started our preparations for commercial readiness that includes the build of the appropriate organization. ![]() In addition, we are in the process of starting clinical research in a second and third indication and this will likely be executed in the same format. To support the expansion of AM-Pharma’s business, we are currently looking for aĪt AM-Pharma, we are actively conducting a global Phase III program treating critically ill patients with acute kidney injury in partnership with a clinical research organization. The bandwidth of the organization will allow for expanding the pipeline and/or accommodating new strategic opportunities. The focus will be on Operational Excellence and flawless execution of pivotal studies with the objective to deliver a quality market authorization submission package and to be ready for launch. The new AM-Pharma organization has involved several new key positions with large pharma / biotech Phase III experience. The company is gearing up to build the organization that will deliver on the next phase of evolution. The focus has since been on funding and execution of the Phase III / registration trial and preparation for launch. In 2018, the company successfully completed a Phase IIb trial in sepsis-associated acute kidney injury patients (SA-AKI). Its most advanced asset, known as Ilofotase Alpha (or recAP), is a fully human recombinant form of AP. AM-Pharma is a clinical-stage biopharmaceutical company developing proprietary recombinant human Alkaline Phosphatase (AP) therapeutics.
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |