Requisition ID 14531BR
Title SR MANAGER - SAMPLE COMPLIANCE
Job Category Commercial Effectiveness
Job Description PURPOSE:
Manage and oversee the Sample Compliance area of FFE Support and Samples and the tasks related to the Sample Accountability Corrective Action Program; field sales related sample investigations; field sales sample non-conformities; expediting activities and ensuring proper closure of internal and external compliance audits; supporting Quality related initiatives for the proper handling of product samples.
RELATIONSHIPS:
This position reports to the Director, FFE Support and Samples and manages a team of professionals. Interacts regularly with the Director and the Sr. Manager, Sampling Operations regarding sample records that correspond to field sales personnel investigations; reconciliation, infractions, corrective action program, training, communications and projects. Interact with Compliance, Human Resources, Legal, Quality and Field Sales employees and applicable third party vendors.
ESSENTIAL FUNCTIONS:
Adhoc Projects:
• Assist the department’s Director on operational and compliance related projects.
Sample Compliance:
• Act as a liaison for establishing and monitoring the business rules that are identified for third party vendors to adhere to, to ensure strict compliance with the PDMA and/or State regulations and NNI procedures.
• Manage and oversee the activities during the reporting periods for CIA, Field Force Monitoring Program and the Sunshine Act to ensure plans and timelines are documented and executed properly.
• Manage and oversee the monitoring and escalation of vendor data reports as it relates to Novo Nordisk – Direct to Physician sampling programs.
• Manage and supervise reporting personnel handling of the day-to-day assignments and periodic projects.
• Manage, oversee and partner with internal stakeholders
• Oversee and conduct periodic audits of other Novo Nordisk areas that manage brand level Direct to Physician programs to ensure PDMA compliance is being met.
• Oversee and escalate sample investigations that involve suspected diversions, loss of product, falsifications, and other sample non-compliance infractions that are required to be reported to the Director, FDA, and/or Novo Nordisk key stakeholders.
• Responsible for reporting appropriate details to the FDA as required by the Prescription Drug Marketing Act (PDMA) and timelines applicable.
Samples Training:
• Manage and oversee the development of sample training programs/presentations conducted by reporting personnel; conduct trainings on a need-be basis. Collaborate with Director and Sr. Manager, Sampling Operations on relevant material.
• Train and/or retrain reporting personnel on current procedures and processes, when applicable.
Trending And Reporting:
• Author and/or provide support in the drafting of sample compliance related work instructions related to internal and field sales procedures and processes. Ensure that the instructions are updated and that applicable direct reports are trained properly and in a timely manner.
• Identify system enhancements that incorporate improvements for monitoring deviations and non-compliance field activities.
• Prepare statistical reports for management on a regular basis to identify trends and issues; and in preparation for annual NN Global Quality audit.
PHYSICAL REQUIREMENTS:
Approximately 5-10% overnight travel.
DEVELOPMENT OF PEOPLE:
• Ensure that development and training plans are in place for all reporting personnel to enable achievement of goals and capability to assume increased levels of responsibility.
• Ensure that reporting personnel have 3P and Individual Personal Development (IDP) completed with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree in management, business or related field required; relevant experience may be substituted for degree when appropriate.
• A minimum of 1 year supervisory/managerial experience preferred.
• A minimum of 5 years’ experience and knowledge of pharmaceutical sampling practicing, Prescription Drug Marketing Act (PDMA) federal regulations and State prescriber level eligibility requirements.
• A minimum of 5 years’ experience in sample operations and compliance required.
• Ability to use and learn IT applications related to sample related transactions.
• Ability to use Microsoft Excel, Access, PowerPoint and Word.
• Ability to work independently.
• Conflict management skills.
• Understanding of business operations – impact of department on other operations.
• Understanding of the pharmaceutical industry, Brand Marketing and Field Sales organizations.
Department CE - FIELD SUPPORT & SAMPLES (2)
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 0 - 10%
Title SR MANAGER - SAMPLE COMPLIANCE
Job Category Commercial Effectiveness
Job Description PURPOSE:
Manage and oversee the Sample Compliance area of FFE Support and Samples and the tasks related to the Sample Accountability Corrective Action Program; field sales related sample investigations; field sales sample non-conformities; expediting activities and ensuring proper closure of internal and external compliance audits; supporting Quality related initiatives for the proper handling of product samples.
RELATIONSHIPS:
This position reports to the Director, FFE Support and Samples and manages a team of professionals. Interacts regularly with the Director and the Sr. Manager, Sampling Operations regarding sample records that correspond to field sales personnel investigations; reconciliation, infractions, corrective action program, training, communications and projects. Interact with Compliance, Human Resources, Legal, Quality and Field Sales employees and applicable third party vendors.
ESSENTIAL FUNCTIONS:
Adhoc Projects:
• Assist the department’s Director on operational and compliance related projects.
Sample Compliance:
• Act as a liaison for establishing and monitoring the business rules that are identified for third party vendors to adhere to, to ensure strict compliance with the PDMA and/or State regulations and NNI procedures.
• Manage and oversee the activities during the reporting periods for CIA, Field Force Monitoring Program and the Sunshine Act to ensure plans and timelines are documented and executed properly.
• Manage and oversee the monitoring and escalation of vendor data reports as it relates to Novo Nordisk – Direct to Physician sampling programs.
• Manage and supervise reporting personnel handling of the day-to-day assignments and periodic projects.
• Manage, oversee and partner with internal stakeholders
• Oversee and conduct periodic audits of other Novo Nordisk areas that manage brand level Direct to Physician programs to ensure PDMA compliance is being met.
• Oversee and escalate sample investigations that involve suspected diversions, loss of product, falsifications, and other sample non-compliance infractions that are required to be reported to the Director, FDA, and/or Novo Nordisk key stakeholders.
• Responsible for reporting appropriate details to the FDA as required by the Prescription Drug Marketing Act (PDMA) and timelines applicable.
Samples Training:
• Manage and oversee the development of sample training programs/presentations conducted by reporting personnel; conduct trainings on a need-be basis. Collaborate with Director and Sr. Manager, Sampling Operations on relevant material.
• Train and/or retrain reporting personnel on current procedures and processes, when applicable.
Trending And Reporting:
• Author and/or provide support in the drafting of sample compliance related work instructions related to internal and field sales procedures and processes. Ensure that the instructions are updated and that applicable direct reports are trained properly and in a timely manner.
• Identify system enhancements that incorporate improvements for monitoring deviations and non-compliance field activities.
• Prepare statistical reports for management on a regular basis to identify trends and issues; and in preparation for annual NN Global Quality audit.
PHYSICAL REQUIREMENTS:
Approximately 5-10% overnight travel.
DEVELOPMENT OF PEOPLE:
• Ensure that development and training plans are in place for all reporting personnel to enable achievement of goals and capability to assume increased levels of responsibility.
• Ensure that reporting personnel have 3P and Individual Personal Development (IDP) completed with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree in management, business or related field required; relevant experience may be substituted for degree when appropriate.
• A minimum of 1 year supervisory/managerial experience preferred.
• A minimum of 5 years’ experience and knowledge of pharmaceutical sampling practicing, Prescription Drug Marketing Act (PDMA) federal regulations and State prescriber level eligibility requirements.
• A minimum of 5 years’ experience in sample operations and compliance required.
• Ability to use and learn IT applications related to sample related transactions.
• Ability to use Microsoft Excel, Access, PowerPoint and Word.
• Ability to work independently.
• Conflict management skills.
• Understanding of business operations – impact of department on other operations.
• Understanding of the pharmaceutical industry, Brand Marketing and Field Sales organizations.
Department CE - FIELD SUPPORT & SAMPLES (2)
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 0 - 10%