Egnyte Jobs

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Posted 2024-11-07

📍 United States

🔍 Cancer clinical research

Bachelor’s degree required, with a preference for a paralegal certificate, JD, or advanced degree.
1-2 years of experience drafting and negotiating contracts is preferred.
Preferred in-depth understanding of the clinical trial process.
Strong communication skills and ability to juggle multiple projects.
Experience working independently and within a team.
Proficiency in Office and document management.

Review and negotiate contracts for clinical trial-related services including various agreements.
Use contract templates and draft amendments and agreements where appropriate.
Ensure internal buy-in and approval of relationship and risk terms.
Maintain accurate and concise communications with all relevant stakeholders.
Develop as a subject matter expert for certain contractual issues.
Establish strong working relationships with relevant teams and maintain contract folders.

Posted 2024-11-07

Posted 2024-08-26

📍 United States

🧭 Full-Time

💸 155000 - 187000 USD per year

🔍 Pharmaceutical/Biopharma

Minimum bachelor's degree in science or IT-related discipline.
Minimum 10 years of professional and management experience in a GxP regulated environment.
Minimum 10 years of Computer System Validation experience in the pharmaceutical/biopharma sector.
Working knowledge of GxP regulations, CSV/CSA principles, and relevant compliance standards.
Awareness of FDA Computer Software Assurance principles.
Ability to lead multiple CSV projects for complex systems.
Understanding of CSV for cloud-based/SaaS systems.
Experience performing third-party vendor audits, focusing on security and privacy.
Knowledge of IT security frameworks such as NIST, ISO/IEC 27001, SOC 2.
Familiarity with regulations like GDPR, HIPAA, and Sarbanes-Oxley.

Provide project and CSV leadership for GxP computerized systems.
Collaborate with IS, vendors, System/Business Owners, and Quality.
Oversee the CSV program, including creating and approving validation documentation.
Own CSV-related incidents and manage remediation efforts.
Perform inspection readiness preparations and support regulatory audits.
Manage change control activities for GxP systems.
Communicate identified gaps and recommend corrective actions.
Serve as IS subject matter expert on Data Integrity and CSV lifecycle.
Partner with others to complete vendor assessments and security evaluations.

Posted 2024-08-26

🔧 Requirements