Neumodx Molecular, Inc.
Location
Ann Arbor, MI | United States
Job description
NeuMoDx Molecular Inc. (“NMDX”) designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. In addition to focusing design and development efforts on tests to detect Respiratory Infections, Sexually Transmitted and Infectious Diseases, NMDX has developed and commercialized a broad range of general purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDT’s) for use with the NMDX Molecular Systems to detect and amplify DNA and RNA targets.
Position: Commercial Program Manager – Ann Arbor, MI
Reports to:Sr. Director, Marketing
Location: Corporate office located in Ann Arbor, MI
Key Responsibilities:
• Adhere to applicable procedures contained within the NMDX Integrated Quality Management System (IQMS).
• Maintain employee training records.
• Lead all activities associated with Phase 5- Commercial Product Release including but not limited to:
◦ Labeling
◦ Translations
◦ Coordinating/monitoring cross-functional activities (V&V, RA, QA, Commercial)
◦ Coordinating launch activities/timelines with Commercial Partners
• Facilitate weekly cross-functional Commercialization Status meetings
• Facilitate Phase V Sign-off and Commercial Transfer meeting
Knowledge, Skills, and Abilities necessary to perform essential functions
• Understanding basic regulatory submission requirements /documents
• Understanding of basic QMS and engineering change release
• Understanding of good documentation practices/mgmt. /revision controls
• Understanding of change control requirements and assessment of design changes
• Basic knowledge of labeling requirement
• Critical thinking/problem-solving/organization skills
• Project management skills
• Work with technical information and subject matter experts to interpret technical requirements
• Ability to take inputs and translate to QMS/Regulatory requirements
• Ability to oversee multiple projects at various stages of completion
• Good communication skills and innate sense of urgency to drive project execution
Minimum Requirements/Qualifications:
• Technical Degree and/or related AA Degree or equivalent experience.
• Minimum two years technical experience or relevant industry experience labelling and commercialization.
• Must have good computer and software skills, including fluency with current Windows operating systems, Outlook, Excel, and Word programs.
• Proficiency with photo and design software and bar code software (i.e. Adobe Photoshop and BarTender)
• Proficient with Excel, MS Word, PowerPoint (MS office suite )
NMDX offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, flexible spending accounts, and medical/dental plans.
For consideration, please submit resume along with salary requirements to [email protected] and mention the job description in the subject. No phone calls please. Only qualified candidates will be contacted.
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