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Principal Regulatory Affairs Consultant - Clinical Pharmacology

USA - Any Region - Home Based Date posted 06/14/2022 Job ID 80285BR

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

Are you a clinical pharmacologist with strong regulatory experience supporting the product development? Are you able to use your skillset to support regulatory and clinical strategy on behalf of clients? Parexel Consulting is growing and we're seeking experienced 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.

Now is the time to join this DYNAMIC Group within our Parexel Regulatory Services Team! As a Principal Consultant you will provide expertise, solutions, and strategy to various clients on exciting products in various stages of development. You will work alongside a distinguished team of Subject Matter Experts who have a wealth of Industry and FDA experience, along with a wide variety of Technical Expertise!

A Principal Consultant within Parexel Regulatory Consulting Services (RCS) 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 RCS 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 RCS.

Project Execution
  • Works within a team environment or individually based on the project needs. Works within broad project guidelines and facilitates issue and conflict resolutions.
  • Prioritizes own workload and may prioritize the workload of the project team in order 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 RCS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RCS 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
  • Delivers presentations at seminars and industry group meetings
  • Authors articles for publication in industry magazines, newsletters, book chapters and other forums
  • May serve as a 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
  • Drives knowledge-centered activities within RCS as well as contributes to Parexel business process improvements. May contribute to new service and consulting model development
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

Qualifications

Responsibilities Continued:
  • 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 junior 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 RCS management and account management
  • Actively prospects and leverages new business opportunities with client and industry contacts in collaboration with Account Management. Presents information about RCS 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

Qualifications:

Education – Successful candidates will have a MD degree from an accredited Medical School with current/previous US Board Certification in Oncology. However, consideration will also be given to exceptional PhD or PharmD candidates with a broad depth of Oncology and Industry related clinical drug development experience.

Language Skills - At least fluent vocal and written English

Minimum Work Experience - Numerous years’ experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design with past experience reviewing and synthesizing large volumes of clinical data; authoring and/or reviewing clinical sections of regulatory applications; planning and driving regulatory strategy; and strong knowledge of FDA Regulatory requirements (EMA exp is a plus). Previous experience with a regulatory agency (such as the FDA or MHRA) in a Medical or Clinical Pharmacology Review is strongly preferred; however, candidates with strong industry backgrounds with Oncology drug development experience will also be considered.

Travel Requirements – up to 20-30% Domestic or International travel may be required in the future

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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