Parexel
Vice President, Technical PC - Medical Device SME
Parexel, Durham, North Carolina, United States, 27703
As one of our ex-FDA colleagues describes it: “you get to see a lot of cool stuff very quickly”.If you’re looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there’s no better place to be than as a
Vice President, Technical
on Parexel’s Regulatory Consulting team! As a VP, Tech you’ll work on a variety of assignments, diverse product types, in an array of therapeutic areas for clients with wide-ranging geographical considerations while enjoying fantastic career opportunities and work/life balance all while working from home.With Parexel Regulatory Consulting, you’ll be creating opportunity for clients throughout the product lifecycle. Sharing your scientific, technical, regulatory and/or commercial expertise with them, so that they can bring better, safer products to market, in line with regulators’ requirements.You’ll be meeting new situations and learning all the time. In fact, one of the key characteristics you’ll see in our VP Techs is innate curiosity along with a passion for the science, the industry, and public health.You’ll be working at a senior / strategic level, and leading teams of respected SMEs in supplying the answers. And, if you’re not already, you’ll soon certainly become a visible figure in the industry.If you’re committed to public health and want to make a difference, this is the ideal role.We’re currently seeking a highly experienced Medical Device Luminary, Health Authority Review Team Lead, Master/Senior Review Officers who are looking to draw upon their wealth of experience in trial design and device development to join Parexel’s highly recognized Regulatory Consulting Services team!A Technical Vice President must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Technical VP must have a thorough understanding of the organization’s consulting models and methodologies, as well as extensive knowledge of what services RCS provides. A Technical VP provides a full range of consulting services and works within their personal area of expertise. A Technical VP provides mentoring and guidance to other RCS employees and leads knowledge-centered activities within RCS. A Technical VP participates in the development of new service offerings, consulting models and methodologies.Project Execution
Works within a team environment or individually based on the project needsWorks within broad project guidelines and leads issue and conflict resolutionsPrioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectivesCapitalizes on opportunities to improve project efficiency, results or team performance and proactively takes actionLeverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisionsProduces quality work that meets the expectations of RCS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RCS are metManages project engagements (small or large)Interacts with the assigned Project Assistant to ensure accurate financial management and for general project supportProvides guidance to project team members and acts as a mentor to junior staffThought Leadership
Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her fieldFrequently authors articles for publication in industry magazines, newsletters, book chapters and other forumsReviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RCS are metRegularly quoted by general and industry news outletsWhen applicable, serves as a leading member of industry association boards, task forces and committees and/or as chairperson or officer of one or more professional associationsContributes expertise to professional societies, academic or other similar groups influential in his/her area of expertiseReinforces the knowledge-centered activities within RCS based on their own knowledge and expertiseFacilitates improvements to the Parexel business processesFacilitates new service and consulting model developmentConsulting Activities and Relationship Management
Adapts the appropriate organization’s consulting models and methodologies when unique situations present themselves as well as designs/improves the methodologies when neededProvides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agenciesCompletes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfactionActs as a trusted advisor to clients, often on issues that lack precedent or are not clearly definedActs as a loaned executive for a client when requiredFacilitates resolutions to possible problems or conflicts within the project team and/or the clientProvides guidance as needed to lower level colleagues on appropriate methods of executing project activitiesDevelops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry driversDemonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provides strategic advice to the C suitePlans and delivers services and solutions which results in clients expressing satisfaction with service provided and builds relationships which results in additional business or referralsIdentifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RCS management and account managementRequirements
Education - MD, MS, or PhD requiredMinimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge medical device (combination product, IVD, and CDx) focused experience in Trial Design, setting Regulatory Strategy, and authoring sections of regulatory applications. Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Review Officer, Team Lead, etc. or a senior related industry related medical device focused role is requiredThe ability to travel up to 20% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
#J-18808-Ljbffr
Vice President, Technical
on Parexel’s Regulatory Consulting team! As a VP, Tech you’ll work on a variety of assignments, diverse product types, in an array of therapeutic areas for clients with wide-ranging geographical considerations while enjoying fantastic career opportunities and work/life balance all while working from home.With Parexel Regulatory Consulting, you’ll be creating opportunity for clients throughout the product lifecycle. Sharing your scientific, technical, regulatory and/or commercial expertise with them, so that they can bring better, safer products to market, in line with regulators’ requirements.You’ll be meeting new situations and learning all the time. In fact, one of the key characteristics you’ll see in our VP Techs is innate curiosity along with a passion for the science, the industry, and public health.You’ll be working at a senior / strategic level, and leading teams of respected SMEs in supplying the answers. And, if you’re not already, you’ll soon certainly become a visible figure in the industry.If you’re committed to public health and want to make a difference, this is the ideal role.We’re currently seeking a highly experienced Medical Device Luminary, Health Authority Review Team Lead, Master/Senior Review Officers who are looking to draw upon their wealth of experience in trial design and device development to join Parexel’s highly recognized Regulatory Consulting Services team!A Technical Vice President must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Technical VP must have a thorough understanding of the organization’s consulting models and methodologies, as well as extensive knowledge of what services RCS provides. A Technical VP provides a full range of consulting services and works within their personal area of expertise. A Technical VP provides mentoring and guidance to other RCS employees and leads knowledge-centered activities within RCS. A Technical VP participates in the development of new service offerings, consulting models and methodologies.Project Execution
Works within a team environment or individually based on the project needsWorks within broad project guidelines and leads issue and conflict resolutionsPrioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectivesCapitalizes on opportunities to improve project efficiency, results or team performance and proactively takes actionLeverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisionsProduces quality work that meets the expectations of RCS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RCS are metManages project engagements (small or large)Interacts with the assigned Project Assistant to ensure accurate financial management and for general project supportProvides guidance to project team members and acts as a mentor to junior staffThought Leadership
Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her fieldFrequently authors articles for publication in industry magazines, newsletters, book chapters and other forumsReviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RCS are metRegularly quoted by general and industry news outletsWhen applicable, serves as a leading member of industry association boards, task forces and committees and/or as chairperson or officer of one or more professional associationsContributes expertise to professional societies, academic or other similar groups influential in his/her area of expertiseReinforces the knowledge-centered activities within RCS based on their own knowledge and expertiseFacilitates improvements to the Parexel business processesFacilitates new service and consulting model developmentConsulting Activities and Relationship Management
Adapts the appropriate organization’s consulting models and methodologies when unique situations present themselves as well as designs/improves the methodologies when neededProvides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agenciesCompletes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfactionActs as a trusted advisor to clients, often on issues that lack precedent or are not clearly definedActs as a loaned executive for a client when requiredFacilitates resolutions to possible problems or conflicts within the project team and/or the clientProvides guidance as needed to lower level colleagues on appropriate methods of executing project activitiesDevelops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry driversDemonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provides strategic advice to the C suitePlans and delivers services and solutions which results in clients expressing satisfaction with service provided and builds relationships which results in additional business or referralsIdentifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RCS management and account managementRequirements
Education - MD, MS, or PhD requiredMinimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge medical device (combination product, IVD, and CDx) focused experience in Trial Design, setting Regulatory Strategy, and authoring sections of regulatory applications. Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Review Officer, Team Lead, etc. or a senior related industry related medical device focused role is requiredThe ability to travel up to 20% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
#J-18808-Ljbffr