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