regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. Provides... for leading all CMC regulatory activities for assigned project(s), in line with ICH requirements, regional requirements...
). Strong experience in Regulatory Information Management (RIM) and Document Management Systems (DMS). Familiarity with CMC data.... Define and document new requirements to align with eCTD 4.0 standards. Work closely with Regulatory Affairs and CMC teams...
agencies. You will provide strategic input and management oversight of regulatory labeling activities for multiple products.... Join Gilead and help create possible, together. Job Description Regulatory Affairs Labeling is a core function within Gilead...
-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global... documents for submission to regulatory authorities. May have one or more direct reports. Provides matrix management...
Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core... authorities. May have one or more direct reports. Provides matrix management and leadership to project teams. Provides...
10+ years of experience in SaaS or cloud-native environments 5+ years using project management tools like Smartsheet... Strong knowledge of project management methodologies (PMP, Agile/Scrum certifications a plus) Excellent communication, leadership...
management, academic experts and patient advocates appropriately, with confidence and professionalism. Strong project... of patients with life-threatening diseases. Senior Director, Public Affairs, U.S. Issues Management Communications Reporting...
develop detailed project timelines and schedules using project management software like Microsoft Project or Primavera.... and assisting the project team with closeout of the project.) Materials Procurement and Management: Coordinates...
issues, detailed level of project management for regulatory compliance modifications Excellent verbal and technical writing... plans, project justification, cost/benefit analysis, and overall management of project implementation and coordinate...
. Provide matrix management and leadership to project teams. Develop and drive continuous improvements in R&D quality processes..., systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality mindset...
integrity, and regulatory guidelines (preferred). Excellent communication and stakeholder management skills. Proficiency...Project Details: Job Title: Scientific Business Analyst (Lab Informatics / Benchling Focus) Location: Foster...
, SOX PMO, Legal, Finance, internal/external auditors, and vendors. Extensive Project and Vendor Management experience... such as EY and other project or data analysis vendors. Management experience; project management and vendor management...
in managing quality in a large, global pharma company. Expert people and project management skills. Possesses in-depth... and influence Quality strategy for Gilead Global Quality Management System (QMS) and the design, implementation and delivery...
. Key Responsibilities: Prepare regulatory documents such as Phase 1 and Phase 2 Clinical Study Reports (CSRs...) and Investigator’s Brochures (IBs) in compliance with regulatory requirements and internal standards. Work under the guidance...
orientation. Demonstrated self-starter with excellent project management expertise and experience. Creative and operationally... all materials are accurate and comply with business conduct and regulatory requirements. Align with Corporate Communications...
activities. A deep knowledge of the regulatory and compliance requirements for HFE and combination product risk management... and Human-Centered Design Specialist you will support innovation and early-stage development, helping drive project strategy...
, or project management teams. In-depth understanding of the pharmaceutical marketing and regulatory landscape. Excellent... change management, project management and communication skills. Ability to collaborate effectively with diverse cross...
clinical trials. Works collaboratively within the department and with cross functional colleagues (e.g., Regulatory, Clinical... Operations, Quality, PDM sub-teams, GSC, etc.) to develop strategies, meet project deliverables, and solve business problems. The...
, including working knowledge of basic project management tools and techniques. Ability to interact effectively with senior... collaboratively within the department and with cross functional colleagues (e.g., Regulatory, Clinical Operations, Quality, PDM sub...
. Project Management: Drive accounting projects within large corporate environments. Conduct User Acceptance Testing (UAT... will report to the Senior Accounting Manager, based in the San Mateo, California. This role involves ensuring project facilitation...