business activities including regulatory filing and change control reference data updates, master data maintenance, and data... of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated leadership...
data is accurate and comprehensive and that protocols comply with regulatory requirements and organizational standards... Change request strategy. Align between cross functional teams including Regulatory team regarding Change control plan...
for deliveries made by the medical writing group, including scientific documents and clinical/medical reports; (2) Contribute... to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing group; and (3...
standards for deliveries made by the medical writing group, including scientific documents and clinical/medical reports; (2...) Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing...
/tasks: See Up4Growth training assignments for the business roles for the associate as per the team matrix and completion... driving drug development such as GMP. Understanding of general regulatory and quality expectations. Good scientific...
for materials submitted through the Medical, Legal, and Regulatory (MLR) process. This role ensures that all content adheres... area developments, industry guidelines, and regulatory requirements relevant to MLR reviews Contributing to process...
guidelines as well as regulatory compliance (e.g., Global Publication Practice). While this role plays an active role...), which must be delivered in adherence with internal and external guidelines as well as regulatory compliance (e.g., Global Publication Practice...
or regulatory areas and perform related tasks with minimal supervision. In addition, an individual in this position... information necessary for regulatory or other purposes; answer routine questions from within and without company and make simple...
development program. (protocol development, database lock, and regulatory submissions/ approvals). Reporting to the Quality... to apply AI for operational efficiency and continuous improvement initiatives. Manage/support regulatory inspection and review responses...