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Parexel · 11 hours ago

Senior/Vice President, Technical (Clinical Regulatory)

United States

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

15+ years exp

Parexel is a leader in drug development and regulatory strategy, seeking a Senior/Vice President, Technical to guide biopharma companies through complex regulatory landscapes. The role involves leading strategic regulatory initiatives, advising clients throughout the product lifecycle, and representing Parexel as a thought leader in the industry.

Pharmaceuticals

H1B Sponsor Likely

Hiring Manager

Lisa B.

Responsibilities

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

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

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

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

Qualification

Clinical DevelopmentClinical Trial DesignRegulatory KnowledgeMedical Review OfficerEndocrinologyNeuroscienceRare DiseaseImmunologyThought LeadershipClient Relationship ManagementMentoring

Required

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

Company

Parexel

Glassdoor3.9

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (23)

2024 (47)

2023 (42)

2022 (51)

2021 (54)

2020 (33)