Senior / Vice President, Technical (Clinical Regulatory)

At Parexel , we don't just support drug development-we help shape it. As a Senior / Vice President, Technical on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding biopharma companies through complex regulatory landscapes to bring safer, more effective therapies to patients worldwide.

You will

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

Represent Parexel as a visible thought leader in the industry

Meet new situations and learn all the time. In fact, one of the key characteristics you'll see in our Sr / VP Techs is innate curiosity along with a passion for the science, the industry, and public health.

If you're committed to public health and want to make a difference, this is the ideal role.

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. A Senior / Vice President Technical provides a full range of consulting services and works within their personal area of expertise. 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.

Project Execution

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

Thought Leadership

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

Requirements

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

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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.