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Vice President, Technical - Regulatory Cell & Gene Therapy CMC

USA - Any Region - Home Based Date posted 06/14/2022 Job ID 79007BR

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

Seeking a CMC Cell & Gene Therapy SME to join Parexel’s highly recognized Regulatory Consulting Team!

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 Regulatory 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.

Parexel’s Regulatory Consulting team is known for our unparalleled breadth and depth of expertise globally. Parexel Regulatory 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.

We currently have a home-based opening on our exceptional Team for an Industry Thought Leader to join Parexel’s Consulting Team of experts as a Vice President, Technical (CMC Cell and Gene Therapy).

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 work load 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 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

Qualifications

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
  • Minimum of an advanced degree in a scientific or technical discipline or MBA, PhD preferred, or equivalent experience
  • Pertinent professional certification such as R.Ph., RAC, CHCC, CQA, CQE, etc also desirable but not mandatory
  • Numerous years experience with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA)
  • Up to 30% domestic / international travel may be required in the future
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!

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO Disclaimer

Parexel 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.

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