• Lead strategic regulatory initiatives across diverse product types and global markets
• Advise clients throughout the product lifecycle, from early development to post-marketing
• Share your scientific, technical, and commercial expertise to influence regulatory outcomes
• Collaborate with and lead teams of respected subject matter experts
• Meet new situations and learn all the time
• A Senior/Vice President Technical provides mentoring and guidance to other RS employees and leads knowledge-centered activities within RS
• A Senior/Vice President Technical participates in the development of new service offerings, consulting models and methodologies
• Works within a team environment or individually based on project needs
• Works within broad project guidelines and leads issue and conflict resolution
• Prioritizes own workload and prioritizes the workload 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 RS and the client
• Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met
• Manages project engagements (small or large)
• 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
• 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 RS 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 RS based on their own knowledge and expertise
• Facilitates improvements to Parexel business processes
• Facilitates new service and consulting model development
• 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 build relationships which results in additional business or referrals

Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management

• Represent Parexel as a visible thought leader in the industry

We’re currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel’s highly recognized Regulatory Strategy team!

• A Senior/Vice President Technical 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 Senior/Vice President Technical must have a thorough understanding of the organization’s consulting models and methodologies, as well as extensive knowledge of what services RS provides
• Education - MD required

Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and expertise in reviewing and evaluating clinical sections of regulatory applications

• Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. or a related medical role is required
• Depth of experience will be considered when determining the level of Senior Vice President Technical or Vice President Technical
• Extensive Endocrinology, Neuroscience, Rare Disease, or Immunology experience is required

The ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance