Vice President, Technical - Clinical Regulatory Affairs (Remote)
Company: Parexel International Corporation
Location: New York
Posted on: March 5, 2025
Job Description:
As one of our ex-FDA colleagues describes it: "you get to see a
lot of cool stuff very quickly".
If you're looking for the opportunity to influence the development
strategies of pace-setting biopharma companies, there's no better
place to be than as a VicePresident, Technical on Parexel's
Regulatory Strategy team (RS)! As a VP, Tech you'll work on a
variety of assignments, diverse product types for clients with
wide-ranging geographical considerations while enjoying fantastic
career opportunities and work/life balance all while working from
home.
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 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 Technical Vice President 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 Technical VP must have a thorough
understanding of the organization's consulting models and
methodologies, as well as extensive knowledge of what services RS
provides. A Technical VP provides a full range of consulting
services and works within their personal area of expertise. A
Technical VP provides mentoring and guidance to other RS employees
and leads knowledge-centered activities within RS. A Technical VP
participates in the development of new service offerings,
consulting models and methodologies.
Project Execution
- 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 staffThought 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 the Parexel business processes
- Facilitates new service and consulting model
developmentConsulting 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 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 managementRequirements
- 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, 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#LI-LB1
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will
receive consideration for employment without regard to legally
protected status, which in the United States includes race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability, or protected veteran status.
Keywords: Parexel International Corporation, New York , Vice President, Technical - Clinical Regulatory Affairs (Remote), IT / Software / Systems , New York, New York
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