Vendor Operations Analyst - Roche and Genentech
South San Francisco, CA
About the Job
Description:
Position is remote but will need to work PST hours.
Job Duties/Responsibilities:
Oversight / Project Management.
Understands the vendor management framework set by the Head of MAP & Safety Partnering and translates the requirements into reporting deliverables (e.g., QA/QC metrics, action items, etc.)
Works with the Vendor Lead on the oversight of GVP/MAP SPs.
Supports the Vendor Lead on all operations performed, including the implementation of policies/procedures that ensure efficient and compliant operations.
Ensures quality and PV requirements are met in accordance with contractual obligations.
Facilitates and participates in SP oversight activities such as SP meetings.
Develops agenda and facilitates meetings with SP.
Tracks statuses for critical milestones and metrics.
Creates action items and follow-ups on action items.
Appropriately escalates to MAP Management Team and Vendor Lead as required.
Communicates closely with local cross-functional teams within US PS to ensure the appropriate level of support is achieved to ensure oversight.
Determines priorities and resource load balancing to manage backlogs, action items, and business as usual.
Leads, coordinates, and collates QC error rates, QC metrics, trends, and gaps for the MAP Management and Vendor Lead.
Leads or assists in the tracking and investigation of case processing-related metrics (e.g., late case investigation) including compliance-related issues set by the vendor management strategy.
Understands the PV environment and works with Vendor Lead and Head of MAP and Safety Partnering to identify SP compliance risks.
Monitoring Performance.
Monitors SP compliance to applicable SOPs and Key Performance Indicators as detailed in the Service Agreement and global/local requirements.
Oversees Corrective and Preventative Actions by the SP, as required.
Supports MAP management and Vendor Lead during audits and inspections.
Issue / Risk Management.
Acts as a day-to-day point of contact with US PS SPs and ensures strong relationships and communication are built between GNE and the SP.
Acts as a point of inquiry for any questions/concerns raised by the SP with appropriate resolution or escalation by Roche/GNE
Provides regular feedback on performance and quality checks to the SP working together with MAP Management and Vendor lead.
Working together with the MAP Management and Vendor Lead communicates any processes or procedural changes.
Escalates any critical decisions or discussions to the Vendor Lead and Head of MAP & Safety Partnering.
Provides support to MAP Management and Vendor Lead by answering questions on Vendor Management reports and deliverables.
Escalates SP risks to the Vendor Lead and MAP Management as required.
Actively identifies process improvement opportunities, gaps, and risks and communicates to MAP Management and Vendor Lead to support continuous quality improvement.
Skills:
Exemplifies strong, dynamic leadership and demonstrates decisiveness and appropriate decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, prioritization of tasks in a timely manner within the scope of responsibility and escalates identified issues to management in a timely fashion.
Works effectively, independently, and collaboratively as a team member with global stakeholders and external business partners,
Strong organizational skills, detail-oriented, and adapts to a fast-paced, changing environment
Demonstrates ownership, initiative, accountability, strong organizational skills, and is solution-oriented Excellent communication skills, both written and verbal
Ability to actively exchange knowledge and ideas
Able to identify potential business gaps and leads in the development and implementation of process solutions
Able to handle the pressure associated with and adapts to a fast-paced, changing environment
Demonstrates ownership, initiative, accountability, strong organizational skills, and is solution-oriented
Inspires others to do their best work by offering encouragement and support Maintains personal and corporate integrity
Education:
Life sciences degree BSc minimum (or 10 years’ experience in a similar role)
5+ years in pharmacovigilance or compliance-related role required
Advanced analytic and computer skills (e.g., Microsoft Excel, other data visualization tools) preferred
Medical terminology experience preferred
Writing experience; science/medical writing highly desirable
Able to travel as per business needs required
Able to be agile and adapt to shifting priorities and needs
Able to be flexible to accommodate differences in vendor time zones.
Pay rate & Benefits:
Hourly Pay Rate Range (dependent on location, experience, expectation)
The pay range that Magnit reasonably expects to pay for this position is: $32.14 - $42.86/hour on W2.
Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met).
Qualification/Licensure:
Work Authorization: Green Card, US Citizen
Preferred years of experience: 5+ Years
Travel Required: No travel required
Shift timings: 9 AM to 5 PM