Scientific Project Manager

Responsibilities:

• Maintain audit and inspection master schedule with regular updated information 
• Coordinate audit scheduling, prepare and confirm subject matter expert (SME) lists, plan audit logistics, etc
• Manage pre-audit requests for information and respond to incoming queries during inspections and audits and ensure timely and accurate responses.
• Triage and manage incoming inspection and audit requests concerning GMO and OCMS processes to subject matter experts (SMEs) Initiate and distribute communications to stakeholder groups before, during and after audit/inspection as required
• Coordinate back-room audit and inspection activities.
• Provide tactical response support during audits and inspections as a global single point-of-contact for GMO and OCMS SMEs.
• Maintain contact lists, organization charts, overview presentations, and information related to past HA inspection findings
• Monitor and respond to GMO Inspection Readiness CSA PV Inspection & Audit Support department mailbox
• Prepare and communicate audit/inspection related metrics and reports on periodic basis System support and content management
• Perform other duties as necessary

Qualifications: 

• Bachelor’s degree required, a discipline in technical or science field preferred; 
• Minimum of 4 years relevant experience is required; 
• Demonstrated experience in participation, management or conduct of audits/inspections required; 
• Experience working in pharmaceutical or other related regulated industry is required; 
• Project Management skills and experience with organizing actions and managing team activities is required
• Highly organized
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks
• Can utilize appropriate initiative and autonomy in achieving objectives
• Strong proficiency in Microsoft Excel and Sharepoint is required
• Knowledge of PV regulatory requirements and experience with safety processing, clinical study safety reporting, pharmacovigilance and medical information preferred
• Must be able to read, write and speak English.
• Requires problem solving skills to interpret data & information, analyze and make recommendations 
• At least 1 year core project management experience
• Pharma experience
• Stable work history