Project manage route and collate PADERs and annual reports for all GE Healthcare Pharmaceutical Diagnostics PDx products

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Project manage, route and collate PADERs and annual reports for all GE Healthcare Pharmaceutical Diagnostics (PDx) products
Support preparation of other US and Canada (USCAN) filings as needed
With the broader GE Healthcare team, develop well organized, complete and compliant post approval submissions for NDAs, ANDAs, and DMFs.
Maintain current knowledge and awareness of US legislation and FDA regulations/guidance that impact post approval regulatory affairs
Complete assigned training and maintain up-to-date knowledge and understanding of current company and department procedures and working practices
Maintain working knowledge of required job systems and processes and prepare working practice and SOP updates as assigned for USCAN-RA
Handle special projects as assigned
Support for other USCAN RA work as appropriate
Quality Specific Goals
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type / position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility.
Qualifications/Requirements:
Bachelor’s degree or minimum 3 years’ progressive experience
Able to work in diversified team environments to leverage a broad viewpoint on problem resolution
Able to prioritize multiple tasks and escalate conflicts appropriately
Able to develop objective analyses, evaluate options & recommend solutions to management
Able to communicate deficiencies to discipline experts (e.g. CMC and Pharmacovigilance)
Able to write internal correspondence that describes SOP gaps or deficiencies
Able to perform crisis assessments & risk-benefit analysis
Desired Characteristics:
Bachelor’s degree in math or science
Strong analytical thinking capability
4 or more years of pharmaceutical post approval regulatory affairs experience preferred
Organized and delivery focused
Ability to manage and prioritize multiple competing priorities and complete tasks on-time
Self-starter
Ability to make sound business judgments
Ability to set and make clear priorities
About Us:With 4000 employees serving 100 countries, GE Healthcare’s Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used in medical imaging exams to improve the visibility of organs, blood vessels or tissues, often helping radiologists distinguish between normal and abnormal conditions. PDx products makes a huge impact worldwide - supporting three patients every second.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Additional Eligibility Qualifications:GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Additional Locations:United States;Illinois, Massachusetts;Marlborough, Arlington Heights or Field Based;

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