Functional Project Manager QA/Regulatory (ADX-202-19)

POSITION SUMMARY:

The Project Manager will provide project management leadership and expertise to enable the organization to meet business objectives. This individual will centrally manage one or more projects and apply project management knowledge, skills, tools, and techniques to project activities to meet project requirements and achieve desired outcomes. The selected candidate will lead projects throughout the entire lifecycle of initiation, planning, execution, monitoring & control, and closing under the leadership directive of the General Manager and Portfolio Manager. The Project Manager will engage subject matter experts and functional leaders to develop integrated project plans, identify stakeholder requirements, and balance competing project constraints of scope, quality, schedule, budget, resources, and risk.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• Assist QA & Regulatory owners/authors with creating plans for the acquisition, review, and finalization of key documents and deliverables for submissions to global regulatory authorities (e.g. notified bodies, FDA, PMDA, NMPA).
• Standardize communications within the Regulatory and Quality department as well as provide regular status and progress updates to Archer’s senior management and core launch teams.
• Strategize with Quality and Regulatory management for the balancing of competing priorities, challenging timelines, and resource deployment.
• Coordinate between the USA and rest-of-world Quality and Regulatory activities to provide comprehensive departmental visibility to all new product submissions and change applications worldwide.
• Drive consistent communication in a fast-growing organization among cross-functional teammates as well as external partners (e.g. pharmaceutical co-development partners, contract vendors).
• Collaborate closely with the Project Management Office to ensure project managers possess accurate information on regulatory deliverables.
• Provide input on regulatory dashboards for review by senior management.
• Document key project decisions and facilitate information management processes
• Prioritize team and physical resource allocations.
• Implement processes to manage and control all types of project change
• Lead project team meetings, develop agendas, follow-up on action items
• Address the needs, concerns, and expectations of all stakeholders through active and collaborative communication
• Effective verbal and written communication with internal and external stakeholders including clients and regulators.
• Willingness to travel up to 10% of the time.
•  Support project teams through the initiation, planning, execution, monitoring/control, and closing of their projects by providing sound project management expertise and coaching.
• Facilitate issue and risk management in collaboration with the project/program teams. 
• Support the implementation of standard project and business management processes and tools. These processes and tools may include the development, monitor, and control of integrated timelines, budgets, risk management plans, communication plans, and business process maps.
• Generate or integrate project-specific metrics/reports and analyzing options and opportunities to optimize the project team’s productivity.
• Collect data for and prepare accurate management of governance committee updates on project status using appropriate templates and tools.
• Establish, maintain and use information repositories and collaboration sites.
• Identify and mitigate project risks.
• Must have demonstrated knowledge of project management skills, tools, and processes in areas such as timeline, cost, and risk management.
• Proficiency in standard project management software and enterprise resourcing planning.
• Effectively communicate project status to external pharma partners throughout the development process
•  Bring forth solutions to meet timelines when at risk. Including manufacturing, software, regulatory, assay development, validation, etc… 

EXPERIENCE:

• Must have experience operating at the individual project level for organizational project management.
• Minimum of 5 years' experience in the diagnostic or pharmaceutical industry.
• Proven ability to coordinate multifaceted projects, including multitasking, deliverables management, and timeline management.
• Demonstrate the ability to work within a commercial environment and influence with and without authority in a cross-functional role.
• Experience in diagnostic development or similar development paradigm

KEY ATTRIBUTES:

• Understanding of 510k and PMA diagnostic approval process from concept to submission.
• Understanding of clinical trial logistics and brining drug and diagnostic from concept to approval.
• High energy, self-motivated, approachable and articulate team player.
• Demonstrates strong leadership capabilities with the ability to lead a cross-functional team (assay development, laboratory, clinical, software, etc.) through a complex development program.
• Significant experience with clinical trials within a biotechnology, pharmaceutical or biopharmaceutical company.
• Demonstrated ability to design and develop products and to interpret and evaluate clinical data.
• The ability to forge strong internal and external partnerships coupled with excellent presentation, communication and interpersonal skills.
• Excellent oral and written communication skills.
• Strong interpersonal, team working, and leadership skills.
• Strong attention to detail demonstrating accuracy in tracking and reporting data.
• Good problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent a recurrence.
• Independent self-management and organizational skills; able to manage workload, set personal and project priorities and adjust as needed.
• Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Excellent work planning and execution/delivery skills – includes problem-solving, prioritization, and task-level influence skills.
• Ability to influence without power.
• Strong ability to communicate both at a detailed (e.g. task status, task management, task execution) level and management through the executive level (e.g., high-level summary verbal and written to sponsors of the planning and execution status).

EDUCATION:

• BS/MS/Ph.D. preferred with relevant training in Chemistry, Manufacturing, and/or Biological Sciences or equivalent experience.
• Project management certification (PMP®, PRINCE2®) or equivalent required.