Senior / Vice President, Regulatory Science- Clinical Regulatory Affairs (Remote)
Parexel
Summary
As a Senior / Vice President, Regulatory Science on Parexel's Regulatory Strategy team, you will work on a variety of assignments and diverse product types for clients with wide-ranging geographical considerations, creating opportunity for clients throughout the product lifecycle.
Job description
Project Execution
- Works within a team environment or individually based on project needs
- Works within broad project guidelines and leads issue and conflict resolutions
- Prioritizes own workload and the workload of the project team to achieve project scope and objectives
- Capitalizes on opportunities to improve project efficiency, results or team performance
- Leverages information from previous projects or other client work to complete assigned project activities and facilitate business decisions
- Produces quality work that meets the expectations of RS and the client; reviews the work of colleagues for content and quality
- Manages project engagements (small or large)
- Interacts with the assigned Project Assistant to ensure accurate financial management and 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
- Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums
- Reviews the thought leadership activities of colleagues for content and quality
- Regularly quoted by general and industry news outlets
- Serves as a leading member of industry association boards, task forces and committees
- Contributes expertise to professional societies, academic or other similar groups
- Reinforces knowledge-centered activities within RS
- Facilitates improvements to Parexel business processes and new service and consulting model development
Consulting Activities and Relationship Management
- Adapts the organization's consulting models and methodologies when unique situations present themselves
- Provides a full range of technical and/or business consulting services across multiple disciplines, including representing clients to regulatory agencies
- Completes and delegates project activities in a timely manner with an understanding of issues impacting 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 problems or conflicts within the project team and/or the client
- Provides guidance to lower-level colleagues on appropriate methods of executing project activities
- Develops and implements business solutions addressing specific client needs
- Interacts professionally at multiple levels including senior and executive management within a client organization
- Presents to client boards and provides strategic advice to the C suite
- Plans and delivers services and solutions resulting in client satisfaction and additional business or referrals
- Identifies opportunities for follow-on business or changes in project scope
Requirements
- MD or PhD required
- 15+ years experience with expert level industry or regulatory knowledge in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications
- Previous experience with a regulatory agency (such as FDA or MHRA) as a Senior/Master Medical Review Officer, Team Lead, or related Medical role strongly preferred
- Extensive General Medicine, Neuroscience, Endocrinology, or Immunology/Rheumatology experience highly preferred
- Ability to travel up to 20-30% domestically and/or internationally may be required
- Internationally recognized professional with proven rainmaking skills and relationships at senior levels within client organizations
- Thorough understanding of consulting models and methodologies
- Demonstrated ability to interact professionally at multiple levels including senior and executive management
Benefits
- Work from home
- Work/life balance
- Career opportunities
Company overview
Parexel is one of the world's largest and most prominent contract research organizations (CROs), providing comprehensive clinical research services to pharmaceutical and biotechnology companies globally. Founded in 1982 and headquartered in Raleigh, North Carolina, Parexel operates with a global workforce of over 24,000 professionals across 84+ facilities in 49 countries. The company specializes in managing the full spectrum of clinical trials from Phase I to IV across diverse therapeutic areas including neuroscience, oncology, infectious diseases, hematology, and general medicine. Parexel offers end-to-end solutions encompassing clinical trial management, regulatory strategy, data management, biostatistics, pharmacovigilance, medical communications, and market access consulting. With a strong track record spanning over 40 years, Parexel has established itself as a trusted partner for both established pharmaceutical leaders and emerging biotech innovators, helping accelerate drug development and bring life-saving treatments to patients faster through its patient-centric approach and operational excellence.