Senior / Vice President, Regulatory Science- Clinical Regulatory Affairs (Remote)

Parexel•United States-Maryland-Remote, MD

17h•Remote

About The Position

Parexel is seeking an experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, or Master/Senior Medical Review Officer to join its Regulatory Strategy team. The role provides consulting expertise throughout the product lifecycle, helping clients bring safer products to market in line with regulators’ requirements. Work may involve varied assignments, product types, and geographic considerations, and is performed from home. The Senior/Vice President is an internationally recognized expert in their field, with established senior-level client relationships and proven business-development capabilities. The role delivers consulting services within the individual’s area of expertise, mentors colleagues, leads knowledge-centered activities, and contributes to developing new service offerings, consulting models, and methodologies. The position also involves leading project teams, providing strategic advice to clients, and building industry visibility through thought leadership.

Requirements

MD or PhD.
At least 15 years of experience with expert-level industry or regulatory knowledge in clinical development or clinical trial design, clinical strategy, and authoring clinical sections of regulatory applications.
Ability to travel up to 20–30% domestically and/or internationally for client or Health Authority meetings and thought leadership or conference attendance may be required.

Nice To Haves

Previous experience at a regulatory agency such as the FDA or MHRA, including as a Senior/Master Medical Review Officer or Team Lead, or in a related medical role; industry subject-matter experts will also be considered.
Extensive experience in General Medicine, Neuroscience, Endocrinology, or Immunology/Rheumatology.
Depth of prior experience will be considered when determining whether the appointment is at Senior Vice President or Vice President level.

Responsibilities

Manage project engagements of varying sizes, independently or as part of a team, and lead issue and conflict resolution.
Set priorities for personal and project-team workloads to achieve project scope and objectives.
Identify and act on opportunities to improve project efficiency, results, or team performance.
Apply insights from prior projects and client work to complete activities efficiently and support business decisions.
Produce and review work to ensure it meets Parexel Regulatory Strategy and client quality expectations.
Coordinate with Project Assistants on financial management and general project support.
Guide and mentor project team members and junior staff.
Present speeches and seminars to industry groups and author articles and other publications based on recognized expertise.
Review colleagues’ thought-leadership materials and reinforce knowledge-centered activities within Regulatory Strategy.
Participate in industry association boards, task forces, committees, professional societies, academic groups, or similar organizations as applicable.
Facilitate improvements to Parexel business processes and the development of new services, consulting models, and methodologies.
Adapt or improve consulting methodologies to address unique situations.
Provide technical and business consulting across service disciplines, including representing clients to regulatory agencies.
Complete or delegate project activities in a timely manner while considering project profitability and client satisfaction.
Act as a trusted client advisor, including on issues without precedent or clear definition, and serve as a loaned executive when required.
Develop and implement business solutions tailored to client needs, applying expertise, best practices, and knowledge of the client’s business and industry.
Present to client boards, advise C-suite leaders, and interact professionally with stakeholders at multiple levels.
Deliver services that satisfy clients and build relationships leading to additional business or referrals.
Identify follow-on business and project-scope opportunities and pursue them with Regulatory Strategy and account management.