Project Manager-Waukegan, IL - Georgia IT Inc.
Waukegan, IL
About the Job
Position: Project Manager
Location: Waukegan, IL
Duration: 12 Months
The Project Manager is responsible for leading diagnostic automation implementation projects. Would be the single person responsible and accountable for ensuring that these projects are completed within scope and on-time. They will be leading multiple simultaneous projects at any given time.
develop new regulatory policies; processes and SOPs and train key personnel on them
Qualifications:
Location: Waukegan, IL
Duration: 12 Months
The Project Manager is responsible for leading diagnostic automation implementation projects. Would be the single person responsible and accountable for ensuring that these projects are completed within scope and on-time. They will be leading multiple simultaneous projects at any given time.
develop new regulatory policies; processes and SOPs and train key personnel on them
- Evaluate regulatory risks of division policies; processes; procedures
- Provide regulatory input to product lifecycle planning
- Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
- Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
- Assist in regulatory due diligence for potential and new acquisitions
- Utilize technical regulatory skills to propose strategies on complex issues
- Determine submission and approval requirements
- Identify emerging issues
- Monitor trade association positions for impact on company products
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Recruit; develop and mentor regulatory professionals
- Assess the acceptability of quality; preclinical and clinical documentation for submission filing
- Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
- Compile; prepare; review and submit regulatory submission to authorities
- Monitor impact of changing regulations on submission strategies and update internal stakeholders
- Monitor applications under regulatory review
- Communicate application progress to internal stakeholders
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
- Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- Provide strategic input and technical guidance on regulatory requirements to development teams
- Manage and execute preapproval compliance activities
- Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
- Ensure compliance with product post marketing approval requirements
- Review and approve advertising and promotional items to ensure regulatory compliance
- Ensure external communications meet regulations
- Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
- Actively contribute to the development and functioning of the crisis/issue management program
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
- Report adverse events to regulatory agencies and internal stakeholders
- Provide regulatory input for product recalls and recall communications
Qualifications:
- Knowledge of regulations and standards affecting diagnostics
- Bachelor's degree in a discipline appropriate to the project environment with minimum five years relevant experience, one year of which must be in leadership/project management roles.
- Negotiate with resource managers to resolve any resource limitations that cannot be resolved by the team.
- Participate on division-initiatives to identify process improvements to accelerate projects.
Source : Georgia IT Inc.