NAMSA
Overview
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Study Director
role at
NAMSA . NAMSA pioneered the industry and was the first independent company in the world to focus on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. NAMSA shapes the industry by supporting clients during every step of the product development lifecycle and beyond. Vision: to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate client success. Mission: to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core values. Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description
Assists in the coordination of study conduct tasks from study initiation to study completion. Performs noncomplex studies and serves as the primary contact for the client, informing schedule and any unforeseen events or issues. Performs projects in compliance with applicable quality system regulations (ISO, GMP, GLP) and NAMSA SOPs. Knows and understands Animal Welfare Requirements and serves as Principal Investigator when applicable. Serves as the Study Director for GLP and non-GLP preclinical studies and ensures that all applicable GLP regulations are followed. May participate in study-specific procedures. Evaluates, analyzes, interprets data and presents in a clear, well-organized, scientifically sound report. Ensures that all data including unanticipated responses are accurately recorded, verified and organized. May ensure study records for GLP studies are archived upon completion of the study. May interact with regulatory bodies (e.g., FDA, NMPA, ANSM). Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary. Interacts with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments as needed. Participates in client discussions regarding study design when needed. Develops and leads moderately complex study designs as needed; serves as primary client contact and keeps the client informed of schedule and issues. Establishes and ensures schedule, budget and quality commitments are met for the client. Manages internal multidisciplinary team members to ensure client expectations are met. Understands investigational product(s) with a high-level understanding of the Medical Device Development Process. Assists with departmental training as needed. Other duties as assigned. Qualifications & Technical Competencies
Requires a minimum of a Bachelors degree, preferably in a scientific discipline, with at least two years of related laboratory experience. Masters degree or PhD with at least one year of relevant laboratory experience. Working Conditions
Regularly exposed to general office conditions and to a variety of livestock, domestic and laboratory animals; may involve fluoroscopy and x-ray imaging. Potential exposure to sharp objects, radioactive isotopes, gases, toxic or caustic chemicals, and a BSL-2 environment. Rarely exposed to zoonotic diseases and bloodborne pathogens. Moderate noise level in the work environment. Regularly required to sit, stand, walk, use hands and fingers, reach, talk and hear, use computer keyboard, and view monitors. May occasionally lift and/or move up to 50 pounds. Specific vision abilities include close vision and the ability to adjust focus. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Business Consulting and Services Referrals increase your chances of interviewing at NAMSA. #J-18808-Ljbffr
Join to apply for the
Study Director
role at
NAMSA . NAMSA pioneered the industry and was the first independent company in the world to focus on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. NAMSA shapes the industry by supporting clients during every step of the product development lifecycle and beyond. Vision: to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate client success. Mission: to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core values. Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description
Assists in the coordination of study conduct tasks from study initiation to study completion. Performs noncomplex studies and serves as the primary contact for the client, informing schedule and any unforeseen events or issues. Performs projects in compliance with applicable quality system regulations (ISO, GMP, GLP) and NAMSA SOPs. Knows and understands Animal Welfare Requirements and serves as Principal Investigator when applicable. Serves as the Study Director for GLP and non-GLP preclinical studies and ensures that all applicable GLP regulations are followed. May participate in study-specific procedures. Evaluates, analyzes, interprets data and presents in a clear, well-organized, scientifically sound report. Ensures that all data including unanticipated responses are accurately recorded, verified and organized. May ensure study records for GLP studies are archived upon completion of the study. May interact with regulatory bodies (e.g., FDA, NMPA, ANSM). Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary. Interacts with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments as needed. Participates in client discussions regarding study design when needed. Develops and leads moderately complex study designs as needed; serves as primary client contact and keeps the client informed of schedule and issues. Establishes and ensures schedule, budget and quality commitments are met for the client. Manages internal multidisciplinary team members to ensure client expectations are met. Understands investigational product(s) with a high-level understanding of the Medical Device Development Process. Assists with departmental training as needed. Other duties as assigned. Qualifications & Technical Competencies
Requires a minimum of a Bachelors degree, preferably in a scientific discipline, with at least two years of related laboratory experience. Masters degree or PhD with at least one year of relevant laboratory experience. Working Conditions
Regularly exposed to general office conditions and to a variety of livestock, domestic and laboratory animals; may involve fluoroscopy and x-ray imaging. Potential exposure to sharp objects, radioactive isotopes, gases, toxic or caustic chemicals, and a BSL-2 environment. Rarely exposed to zoonotic diseases and bloodborne pathogens. Moderate noise level in the work environment. Regularly required to sit, stand, walk, use hands and fingers, reach, talk and hear, use computer keyboard, and view monitors. May occasionally lift and/or move up to 50 pounds. Specific vision abilities include close vision and the ability to adjust focus. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Business Consulting and Services Referrals increase your chances of interviewing at NAMSA. #J-18808-Ljbffr