Senior / Vice President, Technical - Clinical Regulatory Affairs
Location
United States
Posted
1 day ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Senior / Vice President, Technical - Clinical Regulatory Affairs
Parexel
Role Description As a critical member of Parexel's Regulatory Strategy team, you’ll be creating opportunity for clients throughout the product lifecycle. Sharing your scientific, technical, regulatory, and/or commercial expertise with them, so that they can bring better, safer products to market, in line with regulators’ requirements. You’ll be meeting new situations and learning 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. You’ll be working at a senior / strategic level, and leading teams of respected SMEs in supplying the answers. And, if you’re not already, you’ll soon certainly become a visible figure in the industry. 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. Qualifications - 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. - Extensive Neuroscience, Rare Disease, Immunology, Endocrinology/Metabolism experience is highly preferred. - 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. Requirements - 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. Benefits - Fantastic career opportunities and work/life balance. - Opportunity to influence the development strategies of pace-setting biopharma companies. Company Description 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.
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