FDA Regulatory & Intellectual Property -IP Manager

Chenega Corporation•Edinburg, TX

15h•Onsite

About The Position

The Food and Drug Administration (FDA) Regulatory & Intellectual Property (IP) Manager shall conduct specialized activities of the Office of Research and Technology Applications (ORTA) related to supporting researchers and developers.

Requirements

Master’s degree in medical technology, transfer, transition, and/or commercialization or medical regulatory discipline.
Minimum four (4) years' specialized experience in technology transfer, transition, and/or commercialization.
Minimum six (6) years’ experience working with FDA-related regulatory reviews, package submission development, or regulatory process management.
Minimum six (6) years’ experience providing effective technology transfer in support of project activities and objectives for IP protection, patenting, licensing, and business development for commercialization and marketing of finished medical products.
Knowledge of current and draft FDA and international regulations, guidance, and standards applicable to military required medical products.
Knowledge of Defense Health Agency (DHA) and other services FDA and regulatory support operations; actively engages, interacts, and exchanges information with other regulatory experts to promote medical product development for the military.
Knowledge of Mastery of class I and class II medical product development and FDA submission and clearance processes to include premarket notification 510(k) and De Novo risk-based classification process.
Knowledge of class III medical development and FDA submission and approval processes to include Investigational Device Exemption (IDE) packages for using device in clinical studies to collect S&E data required to support a Premarket Approval (PMA) application.
Knowledge of FDA regulatory departments and processes include applicable FDA laws, regulations, policies, procedures, scientific guidelines, and scientific information on unexpected side effects, injury, toxicity or scientific reactions associated with regulated and related products.
Competency in the field of industry and has facilitated the planning, design, and development of governing policies, programmatic issues, and technology development and application.
Possess independent and customer-oriented initiative
Possess knowledge of standard AFMS Microsoft Office Professional Suite products and use of computer database systems.
Ability to communicate clearly, both orally and in writing with comprehensive
Experience with government regulations, policies, procedures and limitations within their scope of responsibilities.
Ability to interpret and provide guidance on DoD, DHA, and USAF T3 policies, IP law, and industry-standard licenses (including royalty rates and license negotiations)

Responsibilities

Review medical research and development proposals, drawings, findings, and ideas to identify any intellectual property (IP) that may be of DoD interest and work with inventors, legal counsel, and TechLink Partnership Intermediary to secure or otherwise patent the IP
Market patents to medical industry, venture capitalists, and others to elicit interest in licensing of IP
Establish licensing agreements that support and emphasize the rapid transfer of the research results to commercial development and fielded capabilities for the US military.
Review proposals and specifically regulatory strategies to provide feedback and recommendations to enable DoD required or desired medical products to be researched, rapidly developed, and manufactured that are safe, effective, affordable, comply with US Food and Drug Administration (FDA) manufacturing requirements, have complete/thorough design history files (DHFs), and are able to obtain quick FDA approval/clearance for the indications the DoD military medical mission requires.
Provide education, training, and assistance to military researchers, clinicians, and project managers related to FDA regulatory regulations, regulatory approval/clearance strategy development, IP management, patent filing, patent licensing agreement processes, and transition of medical research to fielded medical products and capabilities
Manage projects and efforts required to develop early prototypes, test articles, production representative units, and possibly early-stage medical products for Food and Drug Administrative (FDA) approval when industry interest is insufficient to license medical patents for medical products deemed necessary for the US military.
Support government directors, Principal Investigators (PIs), researchers, and project managers in the planning, programming, and execution of clinical research projects and protocols and associated activities to facilitate compliance and rapid achievement of regulatory clearance/approval
Review proposals for product development projects to provide comments on regulatory strategies
Provide revisions to strategies or write new ones to facilitate timely approval/clearance, commercialization, and fielding
Prepare, submit, and manage packages for regulatory review and approval; manage subsequent interactions required to address FDA requirements, questions, and requests for additional information
Develop requirements for content of technical protocols, reports, and summaries used in support of the submissions.
Interpret regulatory statutes, regulations, guidance, and draft documents to assess impact to clinical research and develop solutions to avoid delays in achieving project milestone goals while ensuring compliance.
Represent organization at DoD Regulatory Review Meetings and exchanges to assist with obtaining regulatory approval/clearances, obtain or provide guidance, and possibly develop product prioritization lists for expedited FDA reviews and emergency use authorizations.
Communicate directly with industry, government, and academic counterparts to facilitate technical information exchanges, resolve issues, and optimize regulatory compliance approaches
Provide regulatory subject matter expertise and assistance to the Institutional Review Boards (IRB), Human Research Protection Program, and other departments overseeing all aspects of human and animal research.
Provide tailored regulatory education and training to Principal Investigators (PI), project/program managers, and new researchers
Provide regulatory support and assistance to researchers, principal investigators, and project/program managers conducting or supporting clinical trials
Provide regulatory subject matter expertise and assistance in reviewing and developing Instructions for Use (IFUs), human factors/engineering usability assessments, quality management systems, Risk Hazard Analyses and Management Plans, Requirements Traceability Matrixes, designs/prints for medical devices, product labels, and other aspects with establishing a Design History File (DHF) for new product development
Perform project management functions for coordinating and completing FDA and other regulatory activities
Interact with FDA and other DoD regulatory affairs managers to execute and utilize Public Law 115-92 that authorizes the Department of Defense (DoD) to request, and the U.S. Food and Drug Administration (FDA) to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel.
Senior executive professional, functional, and technical expert in technology transfer and transition (T3) in applying specialized analytical skills to develop draft plans and strategies with securing Intellectual Property and transitioning it to fielded commercially available medical capabilities.
Expert in various technology transfer and transition mechanisms, qualifiers for Intellectual Property (IP) determinations, patent establishment processes, technical products, support systems, studies, planning, establishment of requirements, cost estimating, business development, other related management and technical duties, and resolution of research project issues related to determinations
Provide highly developed technical and functional leadership and direction of complex transitional and translational tasks associated with medical research with technology transfer and intellectual property determination. Serves as resource across many programs and projects. Provides group facilitation, technology transfer training, and provides additional forms of knowledge transfer; provides specialized support to all 59 MDW technology transfer and transition (T3) activities.
Support medical research knowledge and product development and project, program, and portfolio managers as well as research principal investigators (PIs); facilitate interactions between the 59 MDW and academia, non-profit organizations, governmental agencies, and other research and development entities in matters pertaining to patenting and licensing of medical research and commercial product development
Perform T3 services and support as defined by Defense Health Agency (DHA), AFI 61-301, DHA Procedural Instruction 3201.05, DoDI 5535.8, Air Force Instruction 61-301 The Domestic Technology Transfer Process and the Offices of Research and Technology Applications, Cooperatives Research and Development Agreements, the Federal Laboratory Consortium of for Technology Transfer’s Federal Technology Transfer Legislation and Policy (The Green Book, Sixth Edition -2018), Bayh-Dole Act (37 CFR 401), and other applicable federal regulations, policy memos, and instructions.
Work directly with potential inventors to expeditiously develop detailed and complete invention disclosure information package to include identifying and clarifying everyone’s contribution to the refinement and development of the idea(s), creating a succinct problem-solution statement about how the invention will address an issue or provide an enhancement succinct problem, developing an abstract that provides the background of the invention and mirrors the problem-solution statement, and the assisting the completion and submission of a patent application package (Invention Evaluation, Disclosure, Record of Invention, and associated documentation) to legal counsel.
Work directly with AMFMCLO/JAZ legal office to process patent applications
Interface inventors to resolve problems, clarify/refine statements, and answer questions expeditiously execute issuance of a patent
Work with academia and other collaborative research agencies to negotiate, establish, and execute joint patent applications, Joint Ownership Agreements (JOAs), and licensing agreements for supporting government co-inventors and DoD interests. Coordinates customer/3rd party audits of IP/licenses with external and internal personnel as required
Review policies, procedures, research objectives, and organizational structure to provide recommendations to researchers and research leaders or implement changes to eliminate problems or barriers for supporting customers and quality/process improvements for enhancing support, reducing waste, and improving quality.
Review research protocols and related research documents to identify possible Intellectual Property (IP) that may need to be protected/secured through patents, trademarks, or copyrights.
Review and evaluate licensing agreements with commercials to identify, track, report, and manage receipt and processing of funding received from fees and royalty payments that may be generated.
Manage the database for tracking patents, licensing agreements, royalties, and other pertinent documentation and uses information to generate reports to senior management.
Develop and provides researchers, project, program, and portfolio managers with comprehensive training and education on intellectual property, filing patents, establishing licensing agreements, and royalties; instructs researchers on the importance of capturing and documentation of new intellectual property before publishing results.
Plan, organize, direct, and coordinate a review and evaluation process of all organizational research proposals and other documentation for identifying the possible generation of intellectual property to ensure the intellectual property is assessed and will be secured/protected if determined to be patentable.
Support the Office of Research and Technology Applications (ORTA) team with addressing questions about the status of ongoing, completed, and expired agreements and other ORTA activities, documents, and reports for possible generation of and capture of IP; assists with planning, organizing, and coordinating office activities
Collect and compile reported impact of research generated from executed and completed patent applications to create a database of positive and negative outcomes from research, compiles results and reports findings to senior managers.
Maintain and revise process flowcharts and checklist(s) for managing, processing, and optimizing coordination of requests for patent applications,
Review and implement collaborative and cooperative research guidance and directives from Defense Health Agency (DHA), respond to inquiries from DHA and other higher headquarters on number and type of established agreements, provide detailed analyses of DHA interactions to organizational senior management.
Track and Report: Ensures capture and visualization of key metrics of patenting, licensing, and business development processes and related information structured to support continuous process improvement and efficient reporting of research, development, and technology transfer outcomes related to DoD medical modernization objectives and other mandatory report requirements as it relates to T3. Reports generated annually to AF and DHA technology transition office for reporting to mandated Congressional oversight of T3 programs.
Assist researchers with identification and protection of DoD intellectual property from ongoing medical research via the pursuit of provisional patents, patents, copyrights, and trademarks; assist with understanding requirements to protect the intellectual property before publishing or releasing the key elements of research work to the public. Encourages innovation and commercialization of medical knowledge and technological advances by communicating to potential inventors the incentives of securing certain exclusive rights to their ideas and potential inventions as a necessary step to obtaining value to intellectual property and properly transferring it to developers for commercialization and fielding. Performs audits as required at the business unit level to ensure compliance with licensing requirements
Oversee patent submission process with government legal offices, assists with resolving issues or questions related to legal reviews, patent determinations, and filing of accepted patent applications with US patent office. Oversees interactions between government legal and other legal representatives such as patent attorneys for securing intellectual property that was co-developed with academia, non-profit and not-for-profit organizations, governmental agencies, and other research and development entities.
Work with partnership intermediaries such as Techlink and MilTech to market DoD patents to commercial entities by providing requested information, coordinating interactions with the inventor(s), supporting disclosure meetings, and assisting with establishing Patent License Agreements (PLAs) and other agreements to enable developers to license, develop, commercialize, and market medical products that are based on DoD developed intellectual property via established patents.
Support DoD scientific and technical information gathering efforts by collecting and maintaining information in support of the Defense Technology Transfer Information System (DTTIS)
Perform complex and comprehensive analyses and utilize systematic, disciplined, and quantifiable approaches to implement and oversee quality improvement processes for optimizing the use of resources, maximizing efficiency and effectiveness, and improving the support provided to the customer for accomplishing the organizational mission and objectives.
Establish outcome-based metrics for teams and working groups to use in assessing efficiency, effectiveness, risk and compliance with regulatory procedures for completing assigned taskings.
Attend meetings, conferences, briefings, and seminars related to technology transfer operations to provide information/support, learn new skills, address issues, promote medical patents, facilitate licensing discussions, and other enabling activities to solicit business (especially small business) interest and investment.
Maintain technical proficiency through professional interaction with technical and professional societies, academia, symposia, contractors, research and development (R&D) organizations, and/or participation in formal training programs.
Provide project management support. Support in planning, scheduling, administration, participation, and post conference activities of Federal, DOD, and USAF sponsored meetings, conferences, symposia, colloquia, workshops, and scientific advisory boards related to 59 MDW activities. The delivery date will be specified by the COR.
Other duties as assigned