and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory... mechanisms of action to improve the lives of patients. Role Summary The Associate Director of Clinical Supply Management...
& Operations, Regulatory, Commercial). The Associate Director, Patient-Centered Outcomes Research, will support multiple programs... members from internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs...
position based in the south-central US. This position reports to the Senior Director, Apheresis & Infusion Operations for North... Summary The Apheresis & Infusion Specialist (AIS), Associate Director will be a customer-centric member of the team...
, partnering closely with Legal and Regulatory teams to ensure all sourcing, labeling, and marketing activities meet local...About the Role Total Wine & More is seeking a Director, THC Beverages to lead the strategic vision, growth...
more at POSITION SUMMARY: The Senior Director, Clinical Leader (CL) is responsible for development and execution of medical... reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct...
, partnering closely with Legal and Regulatory teams to ensure all sourcing, labeling, and marketing activities meet local...About the Role Total Wine & More is seeking a Director, THC Beverages to lead the strategic vision, growth...
supply of material. The successful candidate will work closely with Clinical Operations, Quality Assurance, Regulatory... competing tasks Experience working cross-functionally with CMC, regulatory, clinical operations, and clinical development...
Role Overview & Key Functions:: The Senior Director of Quality Assurance will provide strategic and operational... leadership for the quality oversight of both drug substance and drug product manufacturing, packaging, labeling and distribution...
and perform regulatory reporting and medical monitoring. As part of your work with beginning-to-end trial experience... management and oversight of all contracted services. Discover Impactful Work: The Associate/Medical Director provides medical...
regulatory activities and documents including post- approval information requests and reports, labeling, and data submissions...Job Description General Summary: Vertex Pharmaceuticals is searching for an experienced Medical Director to lead...
labeling content approval processes and systems, regulatory guidelines and legal boundaries Expert understanding of related...Sr. Director, Global Professional Education, Training – IHFM Many structural heart patients suffer from heart failure...
around the world. To learn more, visit . Job Description The Director of Quality is responsible for overseeing... quality policies, manages and implements quality systems, and facilitates compliance inspections. Manages QA operations...
and perform regulatory reporting and medical monitoring. As part of your work with beginning-to-end trial experience... management and oversight of all contracted services. Discover Impactful Work: The Associate/Medical Director provides medical...
Target Product Profile and Target Labeling. Ensures US Commercial Operations input is provided in the development of Target... research and development, regulatory affairs, etc. Applies innovative and competitive strategies to the development of business...
will also work closely with quality, finance, procurement, regulatory, engineering, operations, consultants and outside vendors..., ensuring that our packaging meets all regulatory requirements, protects product integrity, and enhances user experience. The...
content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project... management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory...
labeling (FDA, USDA, TTB, and standard of identity), and flavor regulatory organizations Design, conduct and/or review flavor... Initiative, Product Development, Prototyping, Research and Development Operations, Strategy Development, Teamwork, Training...
of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting Assist in follow-up... Annual Report) Serve on Safety Management Team and liaise with clinical study/project teams, Clinical Operations, Medical...
attitude, and providing them with opportunities to excel. Position Overview: The Consumer Affairs Manager/Director... into actionable insights for business decision-making. This role ensures consumer trust through regulatory-compliant communication...
Operations which sits within Global Regulatory and Safety Sciences. The Associate Director, Global Labeling Strategy has overall... applications for the role of Global Labelling Strategist Global Labeling Strategy is part of Global Regulatory Strategic...