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Posted : Tuesday, January 16, 2024 10:51 PM
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun.
Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases.
Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC).
Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.
At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition.
She sought to find treatment options and a cure for her daughter and patients like her.
We are founder-led, and relentless in our pursuit of “medicines for life”.
We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute The Senior/Compliance Monitoring & Operations Manager will manage and conduct UT's back-end monitoring (BEM) activities, manage and coordinate live monitoring activities, coordinate audits and perform regular Compliance data analytics to identify risk areas or instances of non-compliance.
As a subject matter expert with solid understanding of healthcare laws and regulations under the FDA, fraud and abuse laws, industry codes and Company policies, this role will contribute to the achievement of the Compliance department's strategic goals performing a broad range of compliance-related tasks such as providing support of UT's Risk Assessment and Mitigation Process (RAMP), the management of several Compliance monitoring & tracking systems, and assisting the various Compliance functions with regular & ad-hoc data analytics to ensure information completeness and accuracy Oversee and conduct ongoing back-end monitoring activities (e.
g.
, HCP engagements, HCP and patient interactions, meals and other transfers of value, Concur expense data); direct and review the work of junior level employees, contractors and temporary associates, as necessary Perform regular & ad-hoc Compliance Data Analytics to identify risk areas or instances of non-compliance; (e.
g.
, compile relevant data to update Compliance dashboards with trends, risk indicators and policy infractions); consistently evaluate existing practices and recommend improvement opportunities for processes and tools to enhance the department's strategic decision making abilities Support the management of UT's Risk Assessment and Mitigation Process (RAMP) including the documentation of remediation outcomes, conducting trend analyses, and developing executive reports for decision making purposes and contributing to the achievement of the department's operational and strategic objectives Manage the coordination of Compliance audits; assist with the planning & execution of interviews, documentation of observations, findings and outcomes Collaborate with the Transparency Reporting function (e.
g.
, compile reports, data validation & analysis, data aggregation and staging, cross referencing, data segmentation) for global, US (federal and state) and associated industry reporting requirements Maintain UT's Compliance incident management and reporting system Recognize and respond to compliance issues in a timely manner, following up to resolve and improve procedures, processes and communications Perform other departmental duties as assigned For this role you will need Minimum Requirements Manager: Bachelor’s Degree Health Science Industry or related field with 8+ years of experience in pharmaceutical/biotechnology industry or 6+ years of experience in pharmaceutical/biotechnology industry with Master's Degree and 5+ years of experience with aggregating and analyzing structured and unstructured data including reporting and visualizing key risk/performance indicators Senior Manager: Bachelor’s Degree Health Science Industry or related field with 10+ years of experience in pharmaceutical/biotechnology industry or 8+ years of experience in pharmaceutical/biotechnology industry with a Master's degree and 7+ years of experience with aggregating and analyzing structured and unstructured data including reporting and visualizing key risk/performance indicators Skilled at organizing and synthesizing data to facilitate understanding of key information and trends; staging information to facilitate reporting and assignment of remediation Understanding of simple statistical sampling methods to facilitate risk-based sampling Skilled at detecting and presenting trends/patterns related to auditing, monitoring and investigation findings, with capacity to do this in a detailed and high level manner Demonstrated knowledge of regulatory and compliance requirements including Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, Sunshine Act, and other relevant regulations Proficiency with Microsoft Office Suite of products; intermediate to advanced level skills in Word, Outlook.
Advanced skills in Excel (e.
g.
, V-Lookups, Pivot Tables, data queries, visualization, data import and format conversions) and PowerPoint (e.
g.
development of slide decks including text and graphics).
Ability to build professional relationships with internal customers and partners Acts with a sense of urgency; high motivation and ability to take initiative, follow through, and completes projects in a professional and expeditious manner Proficiency with and/or ability to learn varied industry software products, such as Veeva, Smart Sheets, Sharepoint, Centris, and similar systems supporting day-to-day compliance operations Position to be office based in Durham, NC Ability to travel up to 20% Preferred Qualifications Master’s Degree Health Science Industry or related field 5+ years of experience in corporate compliance monitoring, auditing, and investigations roles Life science, Data Management & Analytics and Finance/Accounting background At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged.
.
.
all while making a difference in the lives of our patients.
While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness.
Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases.
Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC).
Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.
At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition.
She sought to find treatment options and a cure for her daughter and patients like her.
We are founder-led, and relentless in our pursuit of “medicines for life”.
We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute The Senior/Compliance Monitoring & Operations Manager will manage and conduct UT's back-end monitoring (BEM) activities, manage and coordinate live monitoring activities, coordinate audits and perform regular Compliance data analytics to identify risk areas or instances of non-compliance.
As a subject matter expert with solid understanding of healthcare laws and regulations under the FDA, fraud and abuse laws, industry codes and Company policies, this role will contribute to the achievement of the Compliance department's strategic goals performing a broad range of compliance-related tasks such as providing support of UT's Risk Assessment and Mitigation Process (RAMP), the management of several Compliance monitoring & tracking systems, and assisting the various Compliance functions with regular & ad-hoc data analytics to ensure information completeness and accuracy Oversee and conduct ongoing back-end monitoring activities (e.
g.
, HCP engagements, HCP and patient interactions, meals and other transfers of value, Concur expense data); direct and review the work of junior level employees, contractors and temporary associates, as necessary Perform regular & ad-hoc Compliance Data Analytics to identify risk areas or instances of non-compliance; (e.
g.
, compile relevant data to update Compliance dashboards with trends, risk indicators and policy infractions); consistently evaluate existing practices and recommend improvement opportunities for processes and tools to enhance the department's strategic decision making abilities Support the management of UT's Risk Assessment and Mitigation Process (RAMP) including the documentation of remediation outcomes, conducting trend analyses, and developing executive reports for decision making purposes and contributing to the achievement of the department's operational and strategic objectives Manage the coordination of Compliance audits; assist with the planning & execution of interviews, documentation of observations, findings and outcomes Collaborate with the Transparency Reporting function (e.
g.
, compile reports, data validation & analysis, data aggregation and staging, cross referencing, data segmentation) for global, US (federal and state) and associated industry reporting requirements Maintain UT's Compliance incident management and reporting system Recognize and respond to compliance issues in a timely manner, following up to resolve and improve procedures, processes and communications Perform other departmental duties as assigned For this role you will need Minimum Requirements Manager: Bachelor’s Degree Health Science Industry or related field with 8+ years of experience in pharmaceutical/biotechnology industry or 6+ years of experience in pharmaceutical/biotechnology industry with Master's Degree and 5+ years of experience with aggregating and analyzing structured and unstructured data including reporting and visualizing key risk/performance indicators Senior Manager: Bachelor’s Degree Health Science Industry or related field with 10+ years of experience in pharmaceutical/biotechnology industry or 8+ years of experience in pharmaceutical/biotechnology industry with a Master's degree and 7+ years of experience with aggregating and analyzing structured and unstructured data including reporting and visualizing key risk/performance indicators Skilled at organizing and synthesizing data to facilitate understanding of key information and trends; staging information to facilitate reporting and assignment of remediation Understanding of simple statistical sampling methods to facilitate risk-based sampling Skilled at detecting and presenting trends/patterns related to auditing, monitoring and investigation findings, with capacity to do this in a detailed and high level manner Demonstrated knowledge of regulatory and compliance requirements including Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, Sunshine Act, and other relevant regulations Proficiency with Microsoft Office Suite of products; intermediate to advanced level skills in Word, Outlook.
Advanced skills in Excel (e.
g.
, V-Lookups, Pivot Tables, data queries, visualization, data import and format conversions) and PowerPoint (e.
g.
development of slide decks including text and graphics).
Ability to build professional relationships with internal customers and partners Acts with a sense of urgency; high motivation and ability to take initiative, follow through, and completes projects in a professional and expeditious manner Proficiency with and/or ability to learn varied industry software products, such as Veeva, Smart Sheets, Sharepoint, Centris, and similar systems supporting day-to-day compliance operations Position to be office based in Durham, NC Ability to travel up to 20% Preferred Qualifications Master’s Degree Health Science Industry or related field 5+ years of experience in corporate compliance monitoring, auditing, and investigations roles Life science, Data Management & Analytics and Finance/Accounting background At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged.
.
.
all while making a difference in the lives of our patients.
While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness.
Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
• Phone : NA
• Location : Research Triangle Park, NC
• Post ID: 9006067733
