Contract Legal Specialist, Clinical Development and Grants
1 day ago
Pfizer, S.A. de C.V seeks an experienced Contract Legal Specialist to join our team in the clinical development and grants area.
Key Responsibilities:- Provide training to internal colleagues, contractors, and CRO representatives on legal and process aspects of clinical trial contracting.
- Maintain contract templates and supporting comment and fallback materials and guidance documents.
- Support negotiations with external parties to achieve agreed provisions in various clinical study-related documents.
- Review escalated legal issues from Pfizer clinical teams, external CROs, medical grants teams, and other stakeholders.
- Coordinate with internal and external stakeholders to assess risks and provide holistic legal guidance.
- Develop and implement practical, compliant updates to existing clinical trial legal processes and documents.
- Collaborate with legal counsel, study management, and other colleagues to ensure compliance with global and local regulatory requirements.
- Meet regularly with internal colleagues and CRO legal professionals to coordinate support, share information, and identify emerging issues.
- High School (HS) Diploma or GED
- 6+ years of experience in a biotech/pharma or life sciences industry law firm or company reviewing clinical study contracts and related documents.
- Ability to read, analyze, and interpret legal documents and present information to business partners and management.
- Strong working knowledge of clinical development contracts, ICH-GCP, HIPAA, and relevant complex legal concepts.
- Proven ability to advocate for company positions in challenging negotiations and exercise independent judgment regarding legal matters.
- Excellent communication, problem-solving, analytical thinking skills, and organizational abilities.
$39.21 - $65.35 per hour in Bothell, WA; $43.54 - $76.34 per hour in Cambridge, MA; $43.54 - $76.34 per hour in New York City, NY
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