FDA Regulatory Consultant

Odyssey Systems Consulting Group, Ltd.


Job Description
Odyssey Systems has an exciting new opportunity for an FDA Regulatory Consultant supporting the Food and Drug Administration (FDA). The FDA’s mission is to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. This position is located at FDA headquarters in Silver Spring MD but may be permitted to work remotely on occasion.Duties include, but not limited to:Provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination productsServes as a subject matter expert for regulatory strategy, to include identifying and mitigating risk, and provide support to integrated project teams and working groupsProvide scientific research support that will inform or result in technical guidance and expertise related to regulatory, pharmaceutical, public health and manufacturing functions across the FDAProvide research information, consultation, technical- and functional-analysis that will assist the FDA with decisions on procurements of hardware and software that can be used to advance scientific-related processes, procedures and workflowsProvide technical support to successfully transfer operational databases, models, methods, or tools developed on contractor platforms to FDA internal platforms, including full documentation and codeProvide scientific investigations on evaluating the feasibility and capability for various regulatory policies and actions including Standard Operating Procedures (SOPs), Manuals of Policy and Procedures (MAPPs), and Guidance for FDA-agency level, and Center/Office products; investigations shall include data collection, database development and management, analysis (e.g., computational experiments/research, meta-analysis), method development, critical reviews, technical surveys of industry capability and technology gaps that are not currently addressed by policies and actions (e.g., emerging technology guidance). Scientific investigations may also involve the surveillance and testing of pre- and post-market drugs and drug products as it relates to current world events Submit material for consideration to publish or present health research/consultation related to drug shortages and access due to quality and manufacturing, and public health emergencies due to drug quality, surveillance and manufacturing processes that may have negative impacts on public healthProvide laboratory, technical and administrative support, including assisting, operating, maintaining, calibrating and repairing various laboratory systems, instrumentation and equipment (e.g., benchtop bioreactor systems, cell and biochemical analyzer systems, bio-layer interferometer, and protein purification systems)Provide project management activities related to establishing or reestablishing control, management, monitoring and notification mechanisms necessary; ensuring that contracted tasks stay on track and important milestones and performance measures are metCitizenship: Must be a US citizenClearance: NACI clearance required, but may be required to attain Secret level clearance Education: Bachelor’s degree (Life Sciences preferred)Years’ experience:7+ years' experience in an industry-related Regulatory Affairs environment; Pharmaceutical/Biotechnology, CRO, or Consulting industries and previous non-clinical, toxicology, or pharmacology regulatory writing experience required coupled with past experience interacting and submitting to the FDAPreferred Qualifications:Demonstrated capabilities in meticulous work practices and attention to detailProject management experience with the ability to handle multiple projects at onceAbility to work with vendors to ensure quality and build effective relationshipsAbility to work independently and as part of a team and maintain high ethical standards of integrity and qualityAbility of having an innovative and dynamic approach to workA self-starter able to work independently but comfortable working in a team environmentAdditional Information:Availability of Position is contingent upon contract awardMay be required to travel up to 20-30% domestically and/or internationally#LI-KC1Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.Please note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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