What are the responsibilities and job description for the Director, Global Investigations and Compliance Assurance position at Madrigal Pharmaceuticals?
ABOUT MADRIGAL: Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Title: Director of Global Investigations and Compliance Assurance
Department: Compliance
The Director of Global Investigations and Compliance Assurance is responsible for assisting the Senior Director of Transparency and Compliance Assurance, Compliance Officers and the Chief Compliance Officer with the implementation and management of Madrigal’s Compliance Program. This includes supporting efforts to continuously enhance Madrigal’s Compliance program based on the legal enforcement environment in the U.S. through the application of best practices in the life sciences Compliance space. This role requires significant experience with managing Compliance programs such as Investigations and Monitoring programs. This role requires interaction with other members of the Compliance and Legal teams as well as Sales and Marketing, Information Technology, Finance, Market Access, Medical Affairs, R&D and other functions.
Position Responsibilities
Perform high level complex investigations
Work with other members of the Compliance and Legal team to maintain and enhance the infrastructure for the U.S. business that supports a company culture of compliance and recognizes that compliance is a collective responsibility of all company employees
Develop tools, processes and reports to support the U.S. business’s ownership of Compliance
Participate in routine meetings with U.S. business partners
Create and deliver function-specific trainings and communications
Assist with evaluating and remediating monitoring and investigation findings
Assist with conducting annual compliance risk assessments, including evaluating results and identifying areas of improvement
Conduct field monitoring activities and other office-based auditing/monitoring
Provide guidance to the U.S. Business and integrate compliance controls into the scope of existing business practices where applicable
Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state transparency requirements, state and federal privacy laws, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws
Support Transparency and Monitoring program as needed
Other duties and special projects as assigned
Qualifications And Skills Required
Bachelor's degree required; advanced degree (JD or CPA) and/or people management experience preferred
10 Years of pharma/biotech experience with a minimum of 5 years of pharmaceutical compliance investigations experience
Proven record of accomplishment in the areas of U.S. compliance best practices
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry
Ability to communicate effectively in both verbal and written form with multiple stakeholders within and outside the company
Ability to collaborate and work effectively with cross-functional teams and projects
Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with the input of appropriate input from multiple stakeholders
Strong problem solving and risk analysis skills
Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks
Position is designated as remote; however, 25% travel is required and ability to readily access office locations in either Conshohocken, PA and/or Waltham, MA
Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
Title: Director of Global Investigations and Compliance Assurance
Department: Compliance
The Director of Global Investigations and Compliance Assurance is responsible for assisting the Senior Director of Transparency and Compliance Assurance, Compliance Officers and the Chief Compliance Officer with the implementation and management of Madrigal’s Compliance Program. This includes supporting efforts to continuously enhance Madrigal’s Compliance program based on the legal enforcement environment in the U.S. through the application of best practices in the life sciences Compliance space. This role requires significant experience with managing Compliance programs such as Investigations and Monitoring programs. This role requires interaction with other members of the Compliance and Legal teams as well as Sales and Marketing, Information Technology, Finance, Market Access, Medical Affairs, R&D and other functions.
Position Responsibilities
Perform high level complex investigations
Work with other members of the Compliance and Legal team to maintain and enhance the infrastructure for the U.S. business that supports a company culture of compliance and recognizes that compliance is a collective responsibility of all company employees
Develop tools, processes and reports to support the U.S. business’s ownership of Compliance
Participate in routine meetings with U.S. business partners
Create and deliver function-specific trainings and communications
Assist with evaluating and remediating monitoring and investigation findings
Assist with conducting annual compliance risk assessments, including evaluating results and identifying areas of improvement
Conduct field monitoring activities and other office-based auditing/monitoring
Provide guidance to the U.S. Business and integrate compliance controls into the scope of existing business practices where applicable
Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state transparency requirements, state and federal privacy laws, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws
Support Transparency and Monitoring program as needed
Other duties and special projects as assigned
Qualifications And Skills Required
Bachelor's degree required; advanced degree (JD or CPA) and/or people management experience preferred
10 Years of pharma/biotech experience with a minimum of 5 years of pharmaceutical compliance investigations experience
Proven record of accomplishment in the areas of U.S. compliance best practices
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry
Ability to communicate effectively in both verbal and written form with multiple stakeholders within and outside the company
Ability to collaborate and work effectively with cross-functional teams and projects
Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with the input of appropriate input from multiple stakeholders
Strong problem solving and risk analysis skills
Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks
Position is designated as remote; however, 25% travel is required and ability to readily access office locations in either Conshohocken, PA and/or Waltham, MA
Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
