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Associate Director, Medical Information and Call-Center Operations
Job ID: 2020-2099
Type: Regular Full-Time
# of Openings: 1
Category: Med Affair Ops - Dept
This role will be responsible for the development of Medical Information responses and that the responses are provided in a timely manner. The incumbent will also be responsible for oversight, monitoring, process improvement, and overall performance of the Radius Medical Information Contact Center (MICC) and ensure the activities are compliant and efficient processes that follow Radius policies. They will be the principal contact for call center related activities for Radius internal stakeholders including Medical Affairs, Pharmacovigilance and Product Quality, and will collaborate with internal/external stakeholders to ensure the Medical Information call center is functioning optimally. This role will also be responsible for oversight, budget and compliance for the Medical Information call center(s) following applicable Division and Company policies and procedures.
- To be a key contributor and work cross-functionally with all members of the medical affairs organization and the broader Development team, and additionally with the commercial team to make sure medical information requests are submitted and processed per all Radius policies
- To analyze and interpret scientific data to update or develop comprehensive, balanced, credible, and accurate documents that comply with applicable laws, regulations, guidance's and policies and procedures, and are used to appropriately communicate with customers involved in evidence-based healthcare decisions
- Responsible for evaluating and interpreting medical literature and writing medical information in various formats by substantiating and ensuring the accuracy of referenced materials
- Participation in the development of medically relevant materials including, but not limited to, educational slide decks, manuscripts and AMCP dossier
- Oversight of call-center vendor including operational, training, and monitoring activities including the quality assessment
- Oversight of MICC staff and their management to provide direction on case documentation and processes to meet submission and closure deadlines.
- Ongoing evaluation and assessment of MICC operations with a focus on identification and implementation of process improvements
- Review and optimization of contact center operating hours and staffing,
- Oversight of Contact Case Tracking & Reporting System software functionality. Develop recommendations for improved functionality, ease of agent use, compliance checks, internal and external reporting
- Partner with internal Radius stakeholders to ensure adequate training of MICC Agents including, but not limited to, clinical and product training, product quality complaint reporting and adverse event identification and reporting
- Specifically, this would involve launch of new products, modified and new indications, and new processes
- Ensure documentation and control of MICC training materials and records
- Monitoring of MICC calls and review of case documentation to ensure Radius quality standards are met or exceeded.
- Collaborate with MICC Account Director to provide feedback and development of any corrective actions required to meet quality standards.
- Establish partnerships and cross-functional processes with key internal Radius stakeholders to ensure seamless execution of support operations. Including working in collaboration with:
- Radius Quality Assurance in the identification of deviations and development and implementation of CAPA
- Radius Pharmacovigilance, Quality Assurance and Regulatory Affairs to identify gaps in FDA regulatory adherence and develop plan of action to ensure ongoing compliance
- Radius Medical Affairs and Commercial groups to ensure proper channels for reporting inputs have been identified, established, and operating properly
- Legal and relevant functions and to identify and execute necessary contract modifications, including revision of staffing model to align with volume and hours of operations
- Review daily reports to evaluate trends (negative and/or anomalies) in call volume, handle times, abandon calls and service levels
- Provide monthly reports to Sr. Management on key performance metrics with a summary of the monthly scorecard highlighting any trends and/or issues
- Reconciliation of data/cases between Radius and MICC (weekly, monthly, quarterly)
- Review of open PQC cases at MICC and reconcile with Radius Veeva
- Coordinate quarterly compliance report and cases between MICC and Radius Compliance
- Reconcile all medical information materials (Standard Responses, Knowledge Articles, Slide Decks, etc) between MICC and approved version in Veeva
- Create quarterly audit report for processing/fulfillment of HCP responses to off-label inquiries
- Create, maintain, update Standard Operating Procedures (SOPs) and Work Instructions (WIs) specific to MICC operations
- Manage overall MICC budget including monthly projection meeting and invoice review
- Healthcare professional with prior call center experience required. Pharmacist (Bachelors in Pharmacy), PharmD, or healthcare-related PhD required Pharmaceutical industry or related medical information experience with 5-10+ years of experience in working in and managing call center activities preferred.
- Understanding of, and experience with, Medical Information contact training, case handling and performance reporting
- Understanding of, and experience with, Quality Assurance including Product Complaint Handling.
- Understanding of, and experience with, Pharmacovigilance case processing and reporting
- Understanding of, and experience with, Specialty Pharmacy models and distribution channels.
- Understanding of, and experience with FDA Regulations Part 11, Part 210 and Part 211
- Demonstrated ability to work cross-functionally
- Strong problem-solving skills including structuring, interpreting, and presenting analysis
- Strong project management skills that enable ability to execute complex projects with tight deadlines: strong attention to detail and follow-through
- People management experience leading teams, projects, programs and directing the allocation of resources.
- Experience in sales force technology platforms, software, and data management.
- Possess critical business thinking skills and be comfortable with processes, analytics, desktop tools, software solutions, matrix management and budget management
- Financial management experience of budget management and invoice review
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.