Parexel’s highly recognized Regulatory Consulting Services team is currently seeking a Principal Consultant who is well versed in regulatory strategy and compliance for in vitro diagnostics! This is an incredible opportunity for an individual who is looking for an opportunity to partner with our clients in the very early stages, use his/her expertise to help our clients develop their strategies, and to guide them along the regulatory pathway. This is an exciting and growing area, and this highly visible, dedicated expert will have the unique opportunity to build and grow this practice, and also serve as the leading voice in this subject area.
As a member of Parexel’s Regulatory Consulting Services Team you will be working with a Team of highly experienced professionals with both Industry and FDA experience; you will have the opportunity to work with a variety of clients and products; you will have the opportunity to find solutions and execute on behalf of our clients; you will have the support of a dedicated Team of Business Development Professionals; and you will have the opportunity to continue to advance professionally and stretch your own thinking.
A Principal Consultant must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. Must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, an extensive knowledge of what services PC provides. Provides a full range of consulting services and works within their personal area of expertise. Provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within Regulatory Consulting.
•Works within a team environment or individually based on the project needs. Works within broad project guidelines and facilitates issue and conflict resolutions.
•Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope and objectives
•Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
•Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
•Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met. Manages project engagements (small or large)
•Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support
•Provides guidance to project team members and acts as a mentor to junior staff
•Delivers presentations at seminars and industry group meetings
•Authors articles for publication in industry magazines, newsletters, book chapters and other forums
•May serve as a member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations. Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise
•Drives knowledge-centered activities within PC as well as contributes to Parexel business process improvements.
•May contribute to new service and consulting model development
QualificationsConsulting Activities and Relationship Management and Business Development
•Applies the appropriate organization’s consulting models and methodologies and assists in the design/improvement the methodologies when needed
•Provides a full range of technical and/or business consulting services within personal area of expertise including representing clients to regulatory agencies
•Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
•May act as a trusted advisor to clients, often on issues that lack precedence or are not clearly defined.
•May act as a loaned executive for a client
•Facilitates resolutions to possible problems or conflicts within the project team and/or the client. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
•Develops business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry drivers
•Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization
•Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
•Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management
•Actively prospects and leverages new business opportunities with client and industry contacts in collaboration with Account Management. Presents information about PC service offerings reflecting the organization’s capability to support client needs
•Generates new or repeat business due to personal name recognition or history of client satisfaction and/or relationship
•Leverages rainmaking skills resulting in new and repeat business for Parexel. Is responsible for constant monitoring of his/her “A” list, and is expected to have continued contact with both existing and future potential clients
•Participates in project scoping calls and proposal preparation, delivers sales presentations and participates in bid defense meetings when needed. Actively participates in account planning for key clients
Education – Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree
Language Skills – At least fluent vocal and written English
Minimum Work Experience – 10+ years’ in-vitro diagnostics subject matter expertise coupled with previous regulatory experience to include a minimum 5 years of experience having authored, submitted and/or reviewed marketing authorization submissions to FDA for IVD products and past research and/or lab experience with the development and validation of IVDs
Previous experience with a regulatory agency (such as FDA’s CDRH – Office of (IVD) and Radiology) is preferred, but individuals with strong industry backgrounds will also be considered
Ideally seeking a candidate with the flexibility to work from Parexel’s Bethesda, MD office 2-3 days a week. However, consideration will be given to exceptional candidates in other areas of the United States.
Must have the flexibility to travel @30% domestically and/or internationally.
EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.