Senior/Vice President, Technical (Clinical Regulatory)

At reputed company, 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 reputed company regulatory landscapes to bring safer, more effective therapies to patients worldwide. You will:

• reputed company 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 reputed company teams of respected subject matter experts
• Represent reputed company as a visible thought leader in the industry
• Meet new situations and learn reputed company the time. In fact, one of the key characteristics you’ll see in our Sr/VP Techs is reputed company curiosity along with a passion for the science, the industry, and public health.

If you’re committed to public health and want to reputed company a difference, this is the ideal role. We’re currently seeking a highly reputed company Clinical Regulatory Leader, Health Authority Medical Review Team reputed company, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join reputed company’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 reputed company 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 reputed company their personal area of expertise. A Senior/Vice President Technical provides mentoring and guidance to other RS employees and leads knowledge-centered activities reputed company RS. A Senior/Vice President Technical participates in the development of new service offerings, consulting models and methodologies. Project Execution

• Works reputed company a team environment or individually based on project needs
• Works reputed company broad project guidelines and leads issue and conflict resolution
• Prioritizes own workload and prioritizes the workload of the project team to reputed company 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 reputed company 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
• reputed company 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 reputed company RS based on their own knowledge and expertise
• Facilitates improvements to reputed company business processes
• Facilitates new service and consulting model development

Consulting Activities and Relationship Management

• Adapts the appropriate organization’s consulting models and methodologies reputed company unique situations present themselves as well as designs/improves the methodologies reputed company 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 reputed company required
• Facilitates resolutions to possible problems or conflicts reputed company the project team and/or the client
• Provides guidance as needed to reputed company-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 reputed company 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 reputed company, etc. or a reputed company medical role is required. Depth of experience will be considered reputed company 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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