Senior Specialist/Manager Healthcare Compliance Contractor

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. Support risk-based sample selection using factors such as franchise, geography, venue, program type, prior observations, new product launches and label updates.

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.

 
Requirements:

• 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.

 
Why Should You Apply?

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