Business Segment: Healthcare Technology & Medical Innovation
Location(s): United States ; Wisconsin; Waukesha
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. 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, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: This role is responsible for the development and execution of the research strategy for the Maternal & Infant Care (MIC) segment of the Life Care Solutions (LCS) business by understanding the business needs, marketing strategy and associated unmet clinical needs, through interaction with external research collaborators and partnering with the leaders of the MIC business and other LCS Research Managers.
Essential Responsibilities: - Collaborate with business leaders, functional support personnel, academic institutions and other GRO team members to manage research for the MIC segment. - Determine what research needs are for product development, validation, regulatory submissions, and marketing, based on feature content, intended marketing claims, and regulatory strategy - Work with the LCS Research Manger to develop synergies across the business. - Propose and justify research studies based on established needs of the MIC business; collaborate with Medical, Clinical, Regulatory and Legal functions to obtain approval for the study through appropriate research management review processes - Develop the strategic research needs for the MIC segment. - Prioritize needs and provide a balanced strategy that consists of investigator initiated and sponsored research. - Oversee the active MIC research projects. Provide or seek out domain expertise as needed. - Develop and maintain relationships with key opinion leaders and other clinical experts in the peri-natal care area - Track deliverables; ensure quality and relativeness to the objectives of each study.
Quality Specific Goals: 1. 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.
2. Complete all planned Quality & Compliance training within the defined deadlines.
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
Qualifications/Requirements: - BS in Physics, Chemistry, Biology, or appropriate Engineering/Science/Clinical discipline or related area - Domain expertise in the peri-natal space. - Excellent communication and interpersonal skills - Industry or academic experience in healthcare technology - Ability to prioritize and manage multiple tasks - Must be responsive and willing to take ownership of issues and drive resolution. - Industry or academic experience in healthcare technology - Independently motivated team player able to work closely with a global team and open to sharing information and best practices - Knowledge of technical standards and the ability to apply those standards in a research study - Ability and willingness to travel
Desired Characteristics: - Nursing with peri-natal experience - Clinical experience in either labor & delivery or neonatal ICU - Background in clinical trials research - Previous GE experience - GCP training - Experience working with IRBs / Ethics Committees and regulatory agencies - Good working knowledge of CFR (Code of Federal Regulations) and ISO requirements
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