Scientist

ScientistAlternate/Related Job Titles:Scientist II – Assay DevelopmentR&D Scientist – Regulatory SupportMolecular Diagnostics ScientistLocation:San Diego, CAOnsite Flexibility:Onsite strongly preferred; flexibility may be discussed for candidates within 50 miles SDContract Details:Position Type: ContractContract Duration: 12 monthsStart: As Soon As PossiblePay Rate: $55 – $57/hrJob SummaryThe Scientist supports R&D Assay Development On-Market activities, providing project management, regulatory documentation coordination, and scientific expertise to enable successful global regulatory submissions. This role contributes directly to regulatory response development, product documentation strategy, knowledge repository creation, and coordination of cross-functional inputs. The scientist will operate in a GMP-regulated environment and is expected to communicate effectively across multiple teams.Key ResponsibilitiesRegulatory Submission SupportCoordinate and deliver timely, well-informed responses to global regulatory authorities.Collaborate with Regulatory Affairs, Quality, and R&D to gather and synthesize technical data for submissions.Project ManagementTrack activities, timelines, and deliverables related to regulatory submissions and post-market support.Maintain project schedules and communicate status updates to stakeholders.Lead cross-functional communication to ensure timely input from all partners.Product Knowledge RepositoryDevelop and maintain a comprehensive internal repository of study data, protocols, product documentation, and regulatory correspondence.Ensure documentation is organized, searchable, and up to date.Documentation StrategyReview design history files and existing documentation for completeness and regulatory readiness.Propose new study plans, updates, or documentation enhancements to address gaps.Partner with SMEs to ensure global regulatory compliance.General R&D ResponsibilitiesPlan and execute experimental work independently.Analyze investigations and recommend methods for scientific problem-solving.Write detailed reports describing data, results, and scientific interpretations.Collaborate with cross-functional teams on experimental design and project work.Required ExperiencePhD or MS in life sciences, chemistry, biochemistry, or related fields (or equivalent).3 years in assay development, R&D, or scientific roles; regulated environment experience preferred.Experience supporting global regulatory submissions.Knowledge of molecular diagnostic technology and nucleic acid amplification.Experience working in a GMP environment.Strong technical writing skills and ability to document scientific work.Ability to design and execute experiments, analyze data, and draw valid scientific conclusions.Experience presenting scientific findings to small groups.Nice-to-Have ExperienceBackground in IVD molecular diagnostic assay product development.Familiarity with FDA, CE, PMDA, and global regulatory requirements.Experience creating or managing scientific knowledge repositories.Required SkillsStrong communication and organizational skillsProject management and trackingScientific documentation and technical writingPreferred SkillsAgile methodologiesMicrosoft Outlook, Teams, SharePoint, PlannerOracle and JMPAbility to synthesize complex scientific data for varied audiencesAdditional Skills from Original DescriptionDocumentation review and searchRegulatory response preparationKnowledge-gathering and organizationExperimental design (standard and factorial)Cross-functional collaborationBenefitsMedical, Vision, and Dental Insurance Plans401k Retirement FundAbout the ClientAn innovative medical technology company focused on empowering healthier lives, with a strong commitment to women’s health and early detection, diagnosis, and treatment solutions. The organization values scientific excellence, employee-driven innovation, and improving global well-being.About GTTGTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with major life sciences, biotech, utility, and retail organizations across the US and Canada. We look forward to helping you secure your next great career opportunity!Job Number:25-28375 #gttjobs #LI-GTT #LI-OnsiteCompany DescriptionGlobal Technical Talent is a subsidiary of Chenega Corporation (www.Chenega.com) with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: https://bit.ly/gttcareers AwardsSIA’s Fastest Growing Staffing Firm: 2023 and 2015SIA’s Best Staffing Firm to Work for: 2019 -2023Inc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015Randstad Preferred Supplier: 2020 - 2023TechServe Alliance Excellence Award. 2019NH Business Magazines Fast 5 fastest growing companiesErnst & Young Entrepreneur of the Year Finalist: 2015

Salary : $55 - $57