, including spearheading organizational change management efforts that embed data ethics into the company's culture. Collaborate..., Innovation, Analytics, Privacy, etc.) to operationalize data use guidelines globally, ensuring every project meets our standards...
plans, project milestones, and resource allocation. Provides meeting management support for national MSL team meetings..., efficiency and project management, tracking productivity and operational excellence with key performance indicators (KPIs...
as well as interpretation and reporting of the analyses, and support of regulatory filings. You will champion model-informed... approaches for clinical pharmacology decision-making and for global regulatory submissions, including INDs, IBs, NDAs, BLAs, MAAs...
teams, line management and CROs to assure high quality and timely delivery of written PK reports and regulatory documents..., determine next steps and present data to project teams and senior management. Applicant must demonstrate intellectual...
, project milestones, and resource allocation. Provides meeting management support for national MSL team meetings..., efficiency and project management, tracking productivity and operational excellence with key performance indicators (KPIs...
. Strong project management skills and ability to handle competing priorities independently. Excellent oral and written communication... complex enforcement matters. Stay updated on relevant case law and regulatory developments, such as safe harbor provisions...
plans, project milestones, and resource allocation. Provides meeting management support for national MSL team meetings..., efficiency and project management, tracking productivity and operational excellence with key performance indicators (KPIs...
, including development of work plans, project milestones, and resource allocation. Provide meeting management support... Strong project management, operational leadership, and strategic planning skills. Proven ability to lead cross-functional...
effectiveness managing clinical project deliverables through matrix management. Knowledge & Other Requirements Demonstrated... inputs into regulatory documentation, publications and scientific presentations. We will consider levelling this role up...
development. SAP certification(s) in relevant modules or project management (e.g., PMP, Prosci, ITIL) preferred. Lean Six... organization, enabling digital transformation, operational excellence, regulatory compliance, and stable foundations for growth...
. Project management experience preferred. People leader accountabilities Create inclusion - knowing the business value... clinical trials. Works collaboratively within the department and with cross functional colleagues (e.g., Regulatory, Clinical...
in analytical control systems, assuring network-wide harmonization of control systems by proactive lifecycle management, technical..., specifications, reference standard, and stability sections of regulatory submissions. Build internal knowledge and capabilities...
and project management skills. Exceptional ability to prioritize. Comfortable managing ambiguity. Willingness to travel... for customer experience, digital strategy, internal and external regulatory and governance processes, and systems related...
. * Good organizational and time management skills, including working knowledge of basic project management tools... and techniques. Ability to interact effectively with senior management. In depth understanding and application of relevant...
, instructs and coaches team members in technical, project management and analytical skills. Organizes plans and schedules... maintenance and site services project work. Maintains site compliance documentation and investigates and responds to compliance...
for complex clinical study and programs or initiatives/projects. Project management experience preferred. People leader... clinical trials. Works collaboratively within the department and with cross functional colleagues (e.g., Regulatory, Clinical...
and reporting of the analyses, and support of regulatory filings. You will champion model-informed drug development (MIDD... pharmacology decision-making and for global regulatory submissions, including INDs, IBs, NDAs, BLAs, MAAs, and pediatric plans...
. Biotech, pharmaceutical, or life sciences experience preferred. Excellent communication, stakeholder management, and project... benchmarking, salary range design, vendor management, and compensation analytics, with a strong focus on innovation and operational...
, thorough knowledge of sample management, and regulatory requirements. Experience working with central labs, specialty lab... all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines...
development, operational planning, logistics strategy, and are adept at applying program/project management methodologies. The... and/or supply chain management. Results oriented with attention to detail and a strategic long term planning perspective...