GCP Compliance Manager overseeing compliance activities in clinical trials at Novartis. Managing program/trial compliance and coordination with clinical teams for GCP oversight.
About the role
- Compliance Manager overseeing compliance projects and audits within a healthcare setting. Requires significant experience in healthcare regulation with a strong educational background.
Responsibilities
- Manage/oversee projects, initiatives, regulatory audits or exams, internal audits, accreditations, on-site reviews, risk assessments
- audit planning, conducting mock audits, conducting audit training, managing audit evidence preparation, assessing audit preparedness
- Establish project plans, gap analysis, milestone dates, and other significant aspects, and leadership updates
- Maintain knowledge of laws, regulations, company strategies to assess impact, and consult with clients as subject matter expert
- Conducts complex investigations, document findings, and ensure corrective actions are made
- Conduct complex regulatory requirement and guidance research and provide compliance and ethics related recommendations to operational leadership
- Interface with external clients, regulators, vendors, supplier; internal stakeholders, high level of management
- Ability to travel up to 10%
Requirements
- Requires a BA/BS and minimum of 6 years health care, regulatory, ethics, compliance or privacy experience
- MS/MBA/JD or professional designation preferred
- Experience or background in a clinical, nursing or infusion environment or operation
- CHC or CCEP Certification
Benefits
- merit increases
- paid holidays
- Paid Time Off
- incentive bonus programs
- medical
- dental
- vision
- short and long term disability benefits
- 401(k) +match
- stock purchase plan
- life insurance
- wellness programs
- financial education resources
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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