Vice President, Technical - Medical Devices (Remote)

Incredible opportunity to bring your Health Authority experience and Medical Device expertise to Parexel as a Vice President, Technical!

The VP-Technical (Medical Devices) serves as a luminary in this product area for the Regulatory Consulting business. The VP-Technical (Medical Devices) possesses superior knowledge and specialized training in this area, as demonstrated by their prior roles a senior-level member at a Health Authority or in the pharmaceutical industry (e.g., Medical Device Team Leader, Master/Senior Reviewer, Assoc. Director, Section Head etc.).

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.  The VP-Technical (Medical Devices) must have expert knowledge of relevant laws, regulations, and guidance in this area; as well as demonstrated success in technically evaluating scientific data on medical device products and strategically advising on appropriate development.

To serve as a luminary in Regulatory Consulting, 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.

Job responsibilities include:

Project Execution

• Works within a team environment or individually based on the project needs

• Works within broad project guidelines and leads issue and conflict resolutions

• Prioritizes own workload and prioritizes the workload of the project team 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 Regulatory Consulting (RC) and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RC are met

• Manages project engagements (small or large)

• Interacts with the assigned Project Leader to ensure accurate financial management and for general project support

• Provides guidance to project team members and acts as a mentor to junior staff

Thought Leadership

• Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field

• Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums

• Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of Regulatory Consulting are met

• Regularly quoted by general and industry news outlets

• When 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 associations

• Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise

• Reinforces the knowledge-centered activities within Regulatory Consulting based on their own knowledge and expertise

• Facilitates improvements to the Parexel business processes

• Facilitates new service and consulting model development

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Consulting 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 needed

• Provides a full range of technical and/or business consulting services across multiple disciplines of services 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

• Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined

• Acts as a loaned executive for a client when required

• Facilitates resolutions to possible problems or conflicts within the project team and/or the client

• Provides guidance as needed to junior colleagues on appropriate methods of executing project activities

• Develops and implements 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. Presents to client boards and provide strategic advice to the C suite

• Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and builds relationships which results in additional business or referrals

• Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RCS management and account management

Requirements

• Education - PhD required

• Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in developing key device products such as: companion diagnostics, combination drug-device products, software as a medical device, women's health products (e.g., IUDs), etc.Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Review Officer, Team Lead, etc. or a related Supervisory Review role is strongly preferred, but SMEs with Industry experience will also be considered

• The ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance

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