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Principal Consultant (In-Vitro Diagnostics)

Bethesda, Maryland, United States Date posted 10/19/2020 Job ID post-40024706

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

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.

Qualifications

Consulting 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 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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