PAREXEL International Corporation
Senior Regulatory Affairs Consultant - Non-Clinical/Toxicology
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USA - Any Region - Home Based
Why Work at PAREXEL
There are pivotal moments in every career:
Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That’s PAREXEL. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.
How can we help you on your journey? Find your path, and learn more on LinkedIn
, and Glassdoor
Do you have a passion for toxicology? Are you a Regulatory Affairs expert with a non-clinical focus?
If so, we have a great home-based opportunity to join our Integrated Product Development (IPD) Team as a Non-Clinical Senior Consultant
. Our IPD Team provides clients with the strategies and services around defining and executing the most efficient path to obtaining regulatory approval.
A Senior Consultant within IPD must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, profound knowledge within a business context of what services PC (PAREXEL Consulting) provides. A Senior Consultant develops specialist knowledge of a particular subject matter or market.
Provides a broad range of consulting services and works within broad project guidelines to identify, refine, and address client issues and to achieve project objectives.
Provides guidance to project team members on technical/process issues
Ensures the timely performance of work within a project scope to the quality expectations of PC and the client
Anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.
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 work load and may prioritize the work load of the project team in order to achieve the project scope
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 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 small projects and may manage larger projects
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
Consulting Activities and Relationship Management
Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
Facilitates client decision making by framing issues, presenting options and providing objective business advice
Collaborates with colleagues to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
Acts as a trusted advisor to clients and/or project team on technical and/or process issues
Develops business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
Interacts professionally at multiple levels including senior management within a client organization
Successfully penetrates executive management levels or other business units within a client organization
Facilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in new business/referrals
We are looking for individuals that have:
7 years’ experience in an industry-related Regulatory Affairs environment; Pharmaceutical/Biotechnology, CRO, or Consulting industries
Previous non-clinical, toxicology, or pharmacology regulatory experience required coupled with past experience interacting and submitting to the FDA
A minimum of a Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree Preferred
Language Skills - At least fluent vocal and written English
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.
PAREXEL International Corporation
Website : http://www.parexel.com
With every clinical trial you work on at PAREXEL, you'll be exposed to the future of medicine—contributing to significant life-saving advances and new treatments that are changing lives. So if you are inspired to make a difference in the world, we can help you make it possible.