Senior Specialist/Manager Healthcare Compliance Contractor

Our client, a Biopharmaceutical company, is looking for a Senior Specialist/Manager Healthcare Compliance Contractor for their Foster City, CA location.
 
Responsibilities:

• The contractor will provide hands-on support for the US Speaker Program Monitoring across client and Kite.
• Responsibilities include live, data, and process monitoring; documentation review; risk identification; tracking and reporting; and remediation follow-up.
• The contractor will work under the direction of the US Compliance Monitoring team to identify potential compliance risks, document observations and support timely escalation and remediation.
• Authorized client personnel retain final decision-making authority for observation ratings, escalation, remediation and closure.
• Support the approved speaker program monitoring workplan, sample targets, timelines and trackers.
• Execute assigned live, data and process monitoring using approved tools and procedures.
• Support risk-based sample selection using factors such as franchise, geography, venue, program type, prior observations, new product launches and label updates.
• Coordinate monthly monitoring activities, including monitor scheduling, program preparation, file completion and progress tracking.
• Review monitoring files and supporting documentation to identify and document potential compliance risks, control gaps and follow-up actions.
• Draft clear, objective observations using the approved methodology for company review and approval.
• Track remediation, stakeholder follow-up and closure documentation.
• Review speaker program data, including attendees, meals, room rental, payments, contracting and training records.
• Use approved systems, databases, reporting tools and monitoring trackers to support monitoring activities, documentation and trend analysis.
• Coordinate routine vendor communications, file submissions, invoice support and quality follow-up.
• Analyze monitoring results and data to identify emerging risk trends, recurring issues and areas requiring additional monitoring attention, and prepare metrics, summaries and draft reports.
• Promptly escalate serious, sensitive or time-critical issues to the assignment lead.

• 5+ years of relevant pharmaceutical, biotechnology, healthcare compliance, auditing, monitoring, investigations or risk management experience preferred.
• Knowledge of pharmaceutical speaker program requirements and risks, including promotional communications, speaker training, meals, attendance, transparency reporting, contracting and payments.
• Experience identifying and documenting potential compliance risks through live, data or process monitoring activities.
• Strong analytical skills, including the ability to identify potential risk signals and develop clear, objective observations.
• Strong Excel, project coordination and written communication skills.
• Ability to manage multiple priorities, work independently and handle confidential information with discretion.
• Assignment Expectations:
• The contractor will be employed and paid by the staffing agency.
• The contractor must follow applicable company policies, confidentiality requirements, information-security requirements and agency terms.
• Access to company systems and information is limited to authorized assignment activities.
• The contractor does not have authority to make final policy interpretations, personnel decisions or commitments on behalf of the company.
• Success Measures:
• Assigned monitoring activities are completed accurately and on schedule.
• Files, trackers and supporting documentation are complete and current.
• Potential compliance risks are identified, clearly documented and promptly escalated.
• Remediation and vendor follow-up are tracked through documented closure.
• Deliverables are timely, concise and suitable for leadership review.

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities