- Insmed Incorporated (NJ)
- …to help us expand what's possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs, Tactical Implementation, you'll ... books, cover letter forms, etc.) ensuring clarity, accuracy, and consistency Lead document workflows throughout document lifecycles for regulatory documents,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support to ... This position will also be responsible for establishing and reporting on key project /program metrics in support...The major responsibilities will include but are not limited to: Lead project core teams to ensure on… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... lead and influence others outside of a direct reporting relationshipBroad organizational awareness and knowledge of touch points/interdependenciesDemonstrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Operational Study Strategy and Study Execution while exhibiting leadership qualities.Responsibilities- - Lead the core study team while project managing and ... clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The...vendors levels) and/or issues / risks are escalated to project team level and relevant governance bodies- Lead … more
- USAA (Plano, TX)
- …initiatives including but not limited to: oversight of procedures/process, accurate regulatory reporting and filing, document governance, risk control ... to various stakeholders, build relationships, and influence decision-making. Leadership and Project Management: Proven ability to lead projects, manage multiple… more
- Usaa (Plano, TX)
- …and presenting potential unmitigated risks to the business throughout the project lifecycle. A foundation in accounting principles and critical thinking skills ... with experience risk identification & assessment, measurement & monitoring, and reporting . The ability to clearly and communicate findings, insights, and… more
- Sanofi (Swiftwater, PA)
- …Background in manufacturing and development, Quality Assurance, Quality Control, and Regulatory Affairs. Competencies ( LEAD model) - key competencies the ... are distributed throughout the world. This position guarantees the Quality and Regulatory compliance of products developed, manufactured and distributed by the site… more
- Insmed Incorporated (NJ)
- …for creating and implementing programs that ensure workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key duties ... Insmed's Director of Environmental Health & Safety (EH&S), the individual will lead the development, implementation, and management of a company-wide EH&S program… more
- San Diego Housing Commission (San Diego, CA)
- …reports. Review tenant packets to determine initial or continued eligibility. Perform project site audits to determine compliance with terms of Agreement(s) and/or ... on findings in writing. Train developers, owners and agents on program/ project specific affordability requirements, processes and procedures. Review and approve rent… more
- Merck & Co. (Rahway, NJ)
- …QA policies, safety guidelines, data integrity guidelines, engineering standards, and regulatory issues.- Provides technical, project management and system ... Process Development, Process Control Automation, Process Optimization, Product Formulation, Project Management, Quality Control Management, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …cell-line platforms. This role will be a member of the Process Automation team, reporting to the Process Automation leader. In this role, this individual will be ... test documents. Limited off shift work may be required to meet project , operations, and qualification needs.Execute and develop appropriate system validation, change… more
- Insmed Incorporated (NJ)
- …operational aspects of clinical study planning, implementation, data delivery and reporting . Represents Clinical Operations in a range of cross-functional groups, ... and globally.This role can be hybrid or remote.What You'll Do: Primary operational lead over an 1-2 indications within one compound, in collaboration with the Senior… more
- Eisai, Inc (Dallas, TX)
- …& Cross-functional Influence, Critical Thinking & Business Agility, Industry & Regulatory (Market Access), Mentoring/ People Development, Project Management, ... hear from you. The Associate Director, Access and Reimbursement (AD ARM) will lead the Eisai Access and Reimbursement Managers (ARMs), Eisai's field-based access and… more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership ... Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology) Reporting into the Director Packaging Distribution, Components and Systems… more
- Formation Bio (New York, NY)
- …initial screen through confirmatory diligence and integration. This role will lead late-stage diligence efforts, support asset onboarding post-acquisition, and help ... milestones until steady-state ownership is established.Key ResponsibilitiesDiligence Program Management Lead and manage the full diligence process from initial… more
- USAA (Tampa, FL)
- …procedures, and tools for handling exception alerts and monitoring resulting exception cases. Project Management for Remediation: Lead project teams through ... failures, facilitating risk and compliance remediation, internal and external audits and regulatory exams, and monitoring of the first line of defense to minimize… more
- Insmed Incorporated (NJ)
- …team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Medical Review Committee (MRC), you'll be responsible ... ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials.… more
- Rolls Royce (Indianapolis, IN)
- …and articulate risks and opportunities to program leadership to support decision making. Lead integration activities between project teams and test to ensure ... sufficient oversight for our products to meet business, customer and regulatory requirements. It covers engineers who are performing Development, Systems Engineering… more
- Merck & Co. (Rahway, NJ)
- …Line Lead , Software engineers, Architects, UX designers, Business Analyst, Technical Project Manager, Service Line Lead , other Product Managers, Vendors and ... value product solutions that improve how we run clinical trials and regulatory submission for our patients, partners, and colleagues.As a Technical Product Manager… more
- Sanofi (Swiftwater, PA)
- …management. Deliverable Accountability: Ensure compliance with GMP and regulatory standards (C&Q), including user/functional/detailed specification development, test ... Develop standards and best practices for development and validation activities. Lead cross-functional teams through design reviews and user acceptance testing during… more
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