Senior Vice President, Technical - Clinical Regulatory Affairs

Responsibilities

• Work on a variety of assignments, diverse product types for clients
• Creating opportunity for clients throughout the product lifecycle
• Sharing scientific, technical, regulatory and/or commercial expertise
• Leading teams of respected SMEs
• Meeting new situations and learning
• Provide mentoring and guidance to other RS employees

Requirements

• MD or PhD required
• 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 is strongly preferred
• Extensive Neuroscience, Rare Disease, Immunology, Endocrinology/Metabolism experience is highly preferred
• 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

Certifications & Qualifications

• MD
• PhD