Project Director, Safety Governance

Found in: Resume Library US A2 - 2 weeks ago


Carolina Beach North Carolina, United States AbbVie Full time
Job Description

Purpose

This role partners closely with the Safety Review Board (SRB) Chair and is responsible for providing strategy, direction, and oversight to cross-functional safety governance leaders across AbbVie who are members of the SRB. The SRB is a critical component of AbbVie’s safety governance model, overseeing cross-functional activities impacting the benefit-risk profile of AbbVie products.

Responsibilities

Lead the safety governance function across all AbbVie products, including marketed and pipeline assets, to ensure effective infrastructure for material information flow, compliance with safety governance reporting requirements, and issue escalation to the SRB.

Partner with SRB Chair on relevant company policy and proposed remediation. Execute on approved remediation with Legal consult as appropriate.

Partner with Protocol Safety Review Committee Chair in review of first-in-human clinical trial protocols for new molecular compounds and relevant protocols with administration of biologics to ensure safety provisions are adequately protecting clinical trial subjects, ensure compliance with safety governance requirements, and inform/escalate outcome to SRB as appropriate.

Advise Product Safety Teams (PSTs) and Asset Development Teams (ADTs) on safety governance deliverable requirements and expectations.

Lead and conduct lessons learned, propose recommendations, and execute on endorsed recommendations.

Support SRB-directed initiatives by identifying strategies and collaborating with stakeholders to ensure desired outcomes are met (e.g., Issue Management Team, FDA Advisory Committee, etc.).

Responsible for the integration and onboarding of relevant entities (e.g., subsidiaries, internal committees, consultants, etc.) into the safety governance framework, as required, to support oversight of patient safety.

Accountable for the ongoing revision and development of policies and procedures that ensure safety governance practices are within FDA and Regulatory guidance and compliance. Lead CIA compliance reporting consolidation and ensure continuous audit readiness.

Responsible for identifying and presenting key performance metrics to inform senior leaders on the overall health of safety governance compliance.

Business owner for safety governance systems and responsible for oversight and optimization of technology, automation, resource management, and reporting across multiple teams required to ensure compliance with safety governance requirements.

Significant Work Activities

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required


  • Manager Project Management

    Found in: Resume Library US A2 - 1 week ago


    Charlotte, North Carolina, United States Brightspeed Full time

    Job Description As the Operational Governance and Project Management Manager you will lead a team of high-performing technical project managers responsible for the execution of large-scale, complex projects. You will oversee the planning, implementation, and tracking of projects that have a significant impact on Brightspeed’s financial success. Projects...

  • Project Director

    Found in: Resume Library US A2 - 5 hours ago


    Fayetteville, North Carolina, United States Equus Full time

    Job Description Under supervision and direction of the Project Director, implement total quality management procedures and changes within the case management, enrollment, and customer services units Implement and provide change management when changes to policy / procedure occur Manages communication and coordination of case management, enrollment and...

  • Governance and Risk Project Manager II

    Found in: Resume Library US A2 - 1 week ago


    Raleigh, North Carolina, United States First Citizens Bank Full time

    Overview: This position is responsible for Governance, Risk, and Compliance within the Corporate Real Estate department at First Citizens Bank. The role contributes to the execution of programs across all Corporate Real Estate functions, including Workplace Operations, Facilities Maintenance, Development and Portfolio Administration, Critical Facilities, and...

  • Safety Intern

    Found in: Resume Library US A2 - 1 week ago


    Chapel Hill, North Carolina, United States Consor Engineers Full time

    The Opportunity: As a Safety Intern at Consor Engineering you will have the opportunity to apply your academic knowledge and training in a real-world setting. Under supervision of the Director of Safety and Executive Director of Operational Efficiency you will be assisting with facilitation of the company's safety program. You will learn about construction...

  • Project Archaeologist

    Found in: Resume Library US A2 - 1 week ago


    Raleigh, North Carolina, United States AECOM Full time

    Job Description AECOM is actively seeking a highly talented Project Archaeologist / Field Director for the Raleigh, NC Office. The Project Archaeologist will provide support to cultural resource projects predominately in North Carolina, but may support project throughout the Mid-Atlantic, greater US, and potentially international work, as available. The...

  • Maintenance Director

    Found in: Resume Library US A2 - 1 week ago


    Greensboro, North Carolina, United States Navion Senior Solutions Full time

    Richland Square, a community of Navion Senior Solutions located in Greensboro, NC, is seeking a Maintenance Director to join its rapidly growing team. A great Maintenance Director will have a solid understanding of plumbing and electrical systems as well as carpentry and other crafts. They will be well-versed in all maintenance process and health and...

  • Maintenance Director

    Found in: Resume Library US A2 - 1 week ago


    Greenville, North Carolina, United States Navion Senior Solutions Full time

    Navion of Greenville, a community of Navion Senior Solutions located in Greenville, NC, is seeking a Maintenance Director to join its rapidly growing team. A great Maintenance Director will have a solid understanding of plumbing and electrical systems as well as carpentry and other crafts. They will be well-versed in all maintenance process and health and...

  • Traffic Planner

    Found in: Resume Library US A2 - 5 hours ago


    Nantahala, North Carolina, United States AWP Safety Full time

    Job Description The Traffic Planner will Develop work area traffic control plans that meet customers’ work zone and project phasing requirements as well as ascertain if permit services are required. This role will also support safety initiatives that protect employees, customers, and assets while also supervising and managing safe...

  • Maintenance Director Full-Time

    Found in: Resume Library US A2 - 1 week ago


    Durham, North Carolina, United States Navion Senior Solutions Full time

    Carolina Reserve of Durham, a community of Navion Senior Solutions, is seeking a Maintenance Director to join its rapidly growing team. A great Maintenance Director will have a solid understanding of plumbing and electrical systems as well as carpentry and other crafts. They will be well-versed in all maintenance process and health and safety regulations....

  • Project Manager

    Found in: Resume Library US A2 - 6 days ago


    Raleigh, North Carolina, United States Flatiron Construction Corp Full time

    Overview: As a Project Manager on our US Open Project, you will manage a single project contract to ensure that budget, project personnel and production schedule is completed in compliance with Owner expectations, contract specifications and Company standards. What you will be doing: Manages all aspects of the project, including construction, budget and...

  • Senior Project Manager

    Found in: Resume Library US A2 - 1 week ago


    Raleigh, North Carolina, United States T.A. Loving Company Full time

    Description/Job Summary The senior level of the project management team provides overall management and direction of one (1) or more large revenue projects with a focus on establishing project objectives and procedures through planning, directing, and coordinating construction and financial activities ensuring safe completion on time and under budget....

  • Asst Project Manager

    Found in: Resume Library US A2 - 1 week ago


    Greensboro, North Carolina, United States Cone Health Full time

    Overview:   The Assistant Project Manager (APM) will be responsible for assisting Project Managers and Sr. Project Managers through various project phases from schematic design to close-out, including construction contract administration, budget control, document organization, scheduling, project close-out and end user...

  • Director 2 - Facilities Operations

    Found in: Resume Library US A2 - 1 week ago


    Raleigh, North Carolina, United States Sodexo Full time

    Unit Description: Do you have 5 years of experience as  Director Facilities in a university setting?  Grow your career and develop a team that shares your desire to make a difference.  Sodexo is seeking our Director 2 Facilities Operations at   managing maintenance, custodial and grounds. Our successful candidate will manage Work Force Development,...

  • Maintenance Director

    Found in: Resume Library US A2 - 2 weeks ago


    Forest City, North Carolina, United States Navion Senior Solutions Full time

    Carolina Reserve of Laurel Park, a community of Navion Senior Solutions located in Hendersonville, NC, is seeking a Maintenance Director to join its rapidly growing team. A great Maintenance Director will have a solid understanding of plumbing and electrical systems as well as carpentry and other crafts. They will be well-versed in all maintenance process...

  • Maintenance Director

    Found in: Resume Library US A2 - 1 week ago


    North Augusta, South Carolina, United States Navion Senior Solutions Full time

    Hammond Square, a community of Navion Senior Solutions, is seeking a Maintenance Director to join its rapidly growing team. A great Maintenance Director will have a solid understanding of plumbing and electrical systems as well as carpentry and other crafts. They will be well-versed in all maintenance process and health and safety regulations. The ideal...

  • Maintenance Director

    Found in: Resume Library US A2 - 7 days ago


    Banner Elk, North Carolina, United States Navion Senior Solutions Full time

    Deerfield Ridge Assisted Living, a community of Navion Senior Living, located in Boone, NC is seeking a Maintenance Director to join its rapidly growing team. A great Maintenance Director will have a solid understanding of plumbing and electrical systems as well as carpentry and other crafts. They will be well-versed in all maintenance process and health...

  • Sr. Project Manager

    8 hours ago


    Carolina, United States BSA Technology Full time

    Job DescriptionJob DescriptionJob Description:Major Duties And ResponsibilitiesBe our primary contact with the client, building and maintaining client relationships. Be on-site as required for successful management of the project. Understand, document, review, and communicate project scope, constraints, scope gaps, work-to-go and deadlines to all parties to...

  • XDS Project Coordinator

    Found in: Resume Library US A2 - 1 week ago


    Charlotte, North Carolina, United States Cedar Fair Full time

    Overview: The primary purpose of this position is to provide support for large-scale construction projects. It is also critical to ensure proper financial project tracking and management of park-wide drawings while maintaining regulatory compliance of all construction projects and buildings. Responsibilities: Financial Tracking: Manages and coordinates all...

  • Project Engineer/Project Specialist

    Found in: Resume Library US A2 - 2 weeks ago


    Pineville, North Carolina, United States IPEX Group of Companies Full time

    IPEX is one of the North American leading providers of advanced plastic piping systems. Our mission is to shape a better tomorrow by connecting people with water and energy. We currently have an exciting opportunity as a Project Engineer/Project Specialist. This role is based in our Pineville, NC. office and reports to the Project Engineering Manager....

  • Sales Operations Director

    Found in: Resume Library US A2 - 1 week ago


    Raleigh, North Carolina, United States TRC Companies, Inc. Full time

    About Us: Groundbreaker. Game changer. Pioneer.   TRC has long set the bar for clients who require more than just engineering, combining science with the latest technology to devise innovative solutions that stand the test of time. From pipelines to power plants, roadways to reservoirs, schoolyards to security solutions, clients look to TRC for...