Bring your FDA Office of New Drugs (OND) non‑clinical review expertise to Parexel’s highly regarded Regulatory Consulting Team and play a pivotal role in shaping the future of drug development.

Are you dedicated to public health and committed to making a difference—but feel like you’ve hit a ceiling professionally? At Parexel Regulatory Consulting, we’re growing and seeking experienced regulatory leaders who are passionate about advancing therapies and eager to stretch their thinking, expand their influence, and deliver innovative solutions for our clients.

Parexel’s Regulatory Consulting team is known worldwide for its breadth and depth of expertise. We help clients overcome obstacles to bring products to market faster and smarter. Our scientific, regulatory, and operational knowledge sets the standard for excellence in a constantly evolving healthcare landscape.

We currently have an impactful opening for a Non-Clinical Thought Leader to join our team as Vice President, Technical. This is a senior consulting role for an internationally recognized professional with proven health authority expertise, strong client relationships, and the ability to drive business growth.

As a Vice President, Technical (Non-Clinical) you will:

Project Execution

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

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

• Prioritizes own workload and prioritizes the work load 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 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

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 PC 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 their area of expertise

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

• Facilitate improvements to the Parexel business processes

• Facilitates new service and consulting model development

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 lower-level 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 opportunities with PC management and account management

Requirements

• Minimum of an advanced degree in a scientific or technical discipline or PhD, PharmD, DVM, or MD in fields like pharmacology, toxicology, biomedical sciences, or related disciplines. or equivalent experience

• Pertinent professional certification such as R.Ph., RAC, DBAT, etc. also desirable but not mandatory

• Numerous years experience at the Team Leader, Associate Director, or Director level within the FDA’s Office of New Drugs (OND) with expert level industry regulatory knowledge and experience

• Up to 20-30% domestic / international travel may be required

Now is the time to join this DYNAMIC Team and work alongside like-minded colleagues with a wealth of Industry and FDA experience, along with a wide variety of Technical Expertise!

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