[Remote] R0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based)

Note: The job is a remote job and is open to candidates in USA. Parexel is a leading company in the field of regulatory strategy, seeking a Senior / Vice President, Technical to join their Regulatory Strategy team. This role involves influencing the development strategies of biopharma companies and providing consulting services throughout the product lifecycle, ensuring compliance with regulatory requirements while mentoring junior staff.

Responsibilities

• Works within a team environment or individually based on the project needs
• Works within broad project guidelines and leads issue and conflict resolutions
• 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 the Parexel business processes
• Facilitates new service and consulting model development
• 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 builds 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

Skills

• Education - MD or PhD required
• Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring 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 i.e. Clinical Pharmacology Review is strongly preferred, but SMEs with Industry experience will also be considered
• Prior depth of experience will be considered when determining the level of Senior Vice President Technical or Vice President Technical
• 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
• Extensive Neuroscience, Rare Disease, Immunology, Endocrinology/Metabolism experience is highly preferred

Company Overview

Company H1B Sponsorship