Director, Senior Counsel, Regulatory & Compliance (Remote) - United Therapeutics
Augusta, ME
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
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 Counsel, Regulatory & Compliance role is responsible for a broad range of legal, regulatory and compliance issues affecting the pharmaceutical and biotech industry, including FDA advertising and promotion, False Claims Act, Anti-Kickback Statute, OIG Guidance, the PhRMA Code, the Sunshine Act, and related state regulations. This role is primarily responsible for providing expert legal support to Marketing, Sales, Medical Affairs, Patient Relations, Regulatory Affairs and Corporate Compliance, and for managing the areas of legal responsibility that become relevant through the commercial lifecycle of the Company's various products.
+ Provide guidance to Sales, Marketing, Medical Affairs, Patient Relations, Regulatory and Corporate Compliance departments related to the Food Drug and Cosmetic Act, the False Claims Act, Anti-Kickback Statute, the Sunshine Act and other healthcare related laws and regulations
+ Serve as Legal representative on the Company's promotional review committee, including review of promotional and sales training materials
+ Support the build out of the Company’s Patient Relations function, including providing advice related to reimbursement support, patient support programs, field reimbursement managers, patient navigators and nurse educators
+ Review Needs Assessment Forms related to HCP consulting activities and associated materials
+ Serve as the Legal representative on the Company’s medical communications review, including review of MSL materials, medical information letters, health economic related materials, social media posts
+ Assist with the review, drafting and/or revising of compliance related policies and standard operating procedures, as well as corresponding training materials
+ Assist with privileged compliance audits and investigations, including the development of any corresponding corrective action plans
+ Participate in and provide guidance to the Company’s Compliance Committee
+ Assist the Compliance Department with annual Risk Assessment and Mitigation process, including providing guidance on levels of risk and corresponding risk mitigation activities
+ Stay abreast of changing regulatory and enforcement landscape and keep business leaders informed of the same
+ Manage outside counsel on compliance and regulatory matters
+ Provide backup legal support for general corporate legal issues as required
+ Perform all other related duties as assigned
For this role you will need
Minimum Requirements
+ Juris Doctorate (JD) from an accredited law school
+ 10+ years of experience as an attorney
+ 8+ years of experience in healthcare and FDA law
+ 4+ years of experience as in-house counsel at a pharmaceutical or biotech company
+ Solid command of relevant legal subject matter with the ability to manage collateral areas of legal responsibility that become relevant through the lifecycle of the Company's various products
+ Effective communicator and collaborative team member
+ Strong written communication and drafting skills
+ Mac/PC and MS Office proficient
+ Ability to work in a fast-paced, dynamic environment
+ Candidates preferred location in EST
+ Must be able to travel to RTP, NC at a minimum of one week per month
Preferred Qualifications
+ Experience with Veeva PromoMats
The salary for this position ranges from $230,000 to $285,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
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.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_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
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
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 Counsel, Regulatory & Compliance role is responsible for a broad range of legal, regulatory and compliance issues affecting the pharmaceutical and biotech industry, including FDA advertising and promotion, False Claims Act, Anti-Kickback Statute, OIG Guidance, the PhRMA Code, the Sunshine Act, and related state regulations. This role is primarily responsible for providing expert legal support to Marketing, Sales, Medical Affairs, Patient Relations, Regulatory Affairs and Corporate Compliance, and for managing the areas of legal responsibility that become relevant through the commercial lifecycle of the Company's various products.
+ Provide guidance to Sales, Marketing, Medical Affairs, Patient Relations, Regulatory and Corporate Compliance departments related to the Food Drug and Cosmetic Act, the False Claims Act, Anti-Kickback Statute, the Sunshine Act and other healthcare related laws and regulations
+ Serve as Legal representative on the Company's promotional review committee, including review of promotional and sales training materials
+ Support the build out of the Company’s Patient Relations function, including providing advice related to reimbursement support, patient support programs, field reimbursement managers, patient navigators and nurse educators
+ Review Needs Assessment Forms related to HCP consulting activities and associated materials
+ Serve as the Legal representative on the Company’s medical communications review, including review of MSL materials, medical information letters, health economic related materials, social media posts
+ Assist with the review, drafting and/or revising of compliance related policies and standard operating procedures, as well as corresponding training materials
+ Assist with privileged compliance audits and investigations, including the development of any corresponding corrective action plans
+ Participate in and provide guidance to the Company’s Compliance Committee
+ Assist the Compliance Department with annual Risk Assessment and Mitigation process, including providing guidance on levels of risk and corresponding risk mitigation activities
+ Stay abreast of changing regulatory and enforcement landscape and keep business leaders informed of the same
+ Manage outside counsel on compliance and regulatory matters
+ Provide backup legal support for general corporate legal issues as required
+ Perform all other related duties as assigned
For this role you will need
Minimum Requirements
+ Juris Doctorate (JD) from an accredited law school
+ 10+ years of experience as an attorney
+ 8+ years of experience in healthcare and FDA law
+ 4+ years of experience as in-house counsel at a pharmaceutical or biotech company
+ Solid command of relevant legal subject matter with the ability to manage collateral areas of legal responsibility that become relevant through the lifecycle of the Company's various products
+ Effective communicator and collaborative team member
+ Strong written communication and drafting skills
+ Mac/PC and MS Office proficient
+ Ability to work in a fast-paced, dynamic environment
+ Candidates preferred location in EST
+ Must be able to travel to RTP, NC at a minimum of one week per month
Preferred Qualifications
+ Experience with Veeva PromoMats
The salary for this position ranges from $230,000 to $285,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
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.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_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
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Source : United Therapeutics