This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Vice President, Technical - Regulatory & Clinical Strategy

Parexel International Corporation

USA - Any Region - Home Based

Are you dedicated to Public Health? Committed to making a difference? But you feel like you’ve hit a ceiling professionally and you’re unsure of the next step in your career… Well, Parexel Consulting is growing and we're seeking experienced Regulatory professionals just like you, who are passionate about drug development and who are looking for opportunities to stretch your thinking, advance professionally, and present/execute solutions for our clients.

We are currently seeking experienced Medical Review Officers and Clinical Pharmacology Reviewers who are looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel’s highly recognized Regulatory Consulting Team!

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.

Parexel’s Consulting team is known for our unparalleled breadth and depth of expertise globally. Parexel Consulting overcomes the obstacles to get products to market faster and smarter. Our scientific, regulatory, and operational expertise puts best practice standards to work for clients large and small, designing solutions for a constantly evolving healthcare landscape.

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 PC 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 PC employees and leads knowledge-centered activities within PC. 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 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 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 to ensure accurate financial management and for general project support

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

QualificationsThought 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 his/ her area of expertise

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

Facilitates 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 the opportunities with PC management and account management

Requirements

Education - MD or PhD required

Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications. Previous experience with a regulatory agency (such as the FDA or MHRA) as a Medical Review Officer, Team Lead, Branch Chief or a related Medical role ie. Clinical Pharmacology Review is required.

Previous oncology, endocrinology, neurology, pulmonary or advanced tissue therapy experience is highly preferred

Now is the time to join this DYNAMIC Team and work alongside like-minded colleagues with a wealth of Industry and FDA experience!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.

Job posted: 2020-11-07

3