16 to 30 of 41
Manage/maintain up to date program timelines inclusive of all critical milestones, deliverables, action items, budget, and key interdependencies Apply experienced program management techniques Ensure timely execution of the plan while proposing tradeoffs for scope, timeline, and budget Identify and escalate risks or issues in real time to program team/lead Facilitate risk
Posted 13 days ago
Contribute to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents Author deliverables with consideration for regulatory, corporate, departmental, and quality standards Adhere to medical writing practices, systems, and tools to support clinical studies in order to meet company goals/objectives Verify that standardized pr
Posted 13 days ago
Build/maintain a good business relationship with functional departments Provide quality service and quality oversight on pertinent GMP functions Review and approve validation/lifecycle documentation Assist with facility/equipment/instrument validation documents review and approval Collaborate with internal colleagues through all phases of drug development to ensure compli
Posted 13 days ago
Identify, develop and maintain collaborative relationships with current and future KOLs, scientific experts, cooperative study groups, and study sites Collaborate with key professionals at the national, regional, and local level, educating them with current, fair balanced medical, scientific, and pharmacoeconomic information regarding internal various therapies Increase t
Posted 13 days ago
Perform copy editing for grammar, punctuation, style, and internal consistency Collaborate effectively with other functional area authors to achieve submission schedules as prioritized by senior management Administer QC checks to ensure documents comply with FDA guidelines Develop and manage medical writing processes, SOPs, and templates for key documents Assist with mana
Posted 13 days ago
Collaborate with stakeholder and management to understand the training need, extract detailed information, and develop strong content with a clean design Assist in the content development, delivery of the training program, and activities pertaining to the development of role/activity based RACI matrices for assigned departments Capture and monitor performance metrics Util
Posted 13 days ago
Lead cross functional teams in study start up activities, contract/budgeting, and patient recruitment, enrollment, safety, medical monitoring, etc. Serve as the clinical trial point of contact and liaison between the CRO/vendors and internal team Track and achieve study timelines and milestones, provide appropriate vendor management/oversight, deliver regular internal/ext
Posted 14 days ago
Plan, manage, and execute clinical programs Create and drive study level timeline Establish overall feasibility concept and enrollment plan with input from COMs Build and manage study budget Add input on operational aspects of the protocol Ensure regulatory and GCP compliance Oversee the TMF with periodic audits Lead vendor selection, management, and any issue escalation
Posted 14 days ago
Ensure Good Manufacturing Practice (GMP) internally and at suppliers during the manufacturing, handling, and shipping of the company's products Manage the supplier quality through continuous monitoring and continuous improvement activities with internal cross functional teams and supplier teams Oversee production batch records final approval and product release Review and
Posted 14 days ago
Test packaging materials Develop and validate packaging processes to support regulatory approval Introduce new products to market Draft operating procedures and specifications for equipment/processes Create packaging material master part specifications and/or artwork specifications Prepare packaging and labeling equipment (IQ, OQ, PQ) and process validation (PV) protocols
Posted 15 days ago
Perform work within the regulatory and legal compliance guidelines Identify, cultivate, and maintain long term relationships with targeted oncology centers and KOLs within the oncology community Lead the development of Key Account/engagement plans for each assigned KOL/oncology Center Update relevant stakeholders quarterly Implement a customer centric needs based approach
Posted 15 days ago
Manage study timelines, budgets, CROs, vendors, and consultants for the conduct of clinical studies Maintain expert knowledge of the CNS therapeutic area and CNS indications Lead cross functional teams and shape team dynamics to support collaboration and accountability Oversee performance of one or more clinical studies and serve as the point of contact for all CROs and v
Posted 15 days ago
Manage site feasibility and recruitment, including review of Site Information Questionnaires Review assigned clinical documents and study plans for clarity, accuracy, and following ICH/GCP guidelines Evaluate data fields within the electronic data capture (EDC)systems, including performing, collating, and downloading reports to support study management and data review Par
Posted 20 days ago
Evaluate reliability and drive reliability growth for existing products Build reliability models for new products and establish reliability metrics for new and existing products Work with design engineers to optimize designs for reliability Participate in failure analysis and root cause investigations Promote a reliability driven culture in the R&D team Develop and run QA
Posted 21 days ago
Develop and apply metrics and data analysis to identify and implement process, quality, and system improvements Lead initiatives focused on defining/maintaining clinical data standards and execute a Data Quality Assurance program to ensure data collection, integration, transformation, and usage occur accurately/consistently Establish and design data production processes D
Posted 21 days ago
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