Senior Vice President, Technical - Clinical Regulatory Affairs
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Job Description
Senior/Vice President, Technical overseeing regulatory strategies for biopharma clinical development. Work from home position with significant impact on patient therapeutic developments.
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
Benefits:
- Work from home
- Opportunity to influence development strategies
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