Senior Manager, Compliance

SENIOR MANAGER, COMPLIANCE

Melinta Therapeutics is a biopharmaceutical company with strong commercial and medical capabilities dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. Melinta’s current portfolio includes seven commercial stage products and one investigational product under review by FDA: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate), VABOMERE® (meropenem and vaborbactam), and cefepime-taniborbactam. With an unsurpassed commitment to providers and patients, Melinta is dedicated to saving lives threatened by the global public health crisis of infections. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge and flexibility are valued.

Melinta’s portfolio has the unique ability to offer providers and patients a range of solutions that can meet the tremendous need for treating serious infections. Visit www.melinta.com for more information.

Job Purpose

The Senior Compliance Manager is a member of Melinta’s Legal and Compliance team and is responsible for supporting the day-to-day operations of Melinta’s Comprehensive Compliance Program. The Compliance Manager reports directly to the Senior Director of Compliance and will provide support to Melinta’s comprehensive compliance program, including, but not limited to matters relating to policies and procedures, reporting obligations, training and Melinta’s auditing and monitoring program.

Core Competencies And Experience

Experience working in a compliance/operational role at a pharmaceutical company, including:

• Experience in administering the process for capturing, extracting, reviewing, remediating and analyzing HCP/HCO transfer of value and interaction data from internal and external sources to ensure compliance with applicable US federal and state reporting requirements and company policies
• Working k nowledge of key healthcare compliance requirements for a comprehensive compliance program, particularly U.S. laws, regulations, and applicable industry codes (i.e., OIG/DOJ guidance; PhRMA Code; Federal Food, Drug and Cosmetic Act; Anti-kickback Statute; False Claims Act; and state and federal compliance and transparency reporting requirements (e.g. audit/compliance certifications, pharmaceutical representative registrations and licensures, spend transparency reporting, sample reporting and price transparency reporting)
• Familiarity with developing and/or executing elements of a comprehensive compliance program, including annual healthcare compliance auditing and monitoring plan
  
  
  

Duties And Responsibilities

Comprehensive Compliance Program Support

• Monitor laws and regulations regarding US federal and state spend transparency and other healthcare compliance requirements
• Maintain business rules and identify areas for improvement to maintain accurate, comprehensive and efficient data capture and review processes
• Develop content and train internal teams and vendors on transparency requirements, data capture and validation processes
• Lead review and analysis of HCP/HCO transfer of value data from internal and external sources to ensure compliance with applicable US federal and state reporting/compliance requirements and company policies and manage remediation activities
• Serve as liaison between third-party service providers and Melinta’s reporting vendor
• Ensure timely and accurate data submissions for Open Payments, state disclosure law reports and other compliance audits/certifications/requirements as needed
• Prepare updates for Executive and/or Compliance Committee as needed
• Develop, implement and/or update compliance policies and standard operating procedures for continued enhancement of Melinta’s comprehensive compliance program
• Assist with the design/execution of Melinta’s auditing and monitoring program, including collecting, reviewing, and analyzing relevant data to ensure compliance with applicable policies
• Assist with management of HCP engagements, including review of needs assessments, completion of debarment/exclusion checks, fair market value assessments, facilitation of HCP contracting processes and collection of proof of performance documentation
• Assist with management, review and assessment of exhibit and sponsorships requests/activities
• Assist with managing timely and accurate drug price transparency report submissions
• Assist in designing, implementing, and maintaining effective and efficient communication tools, including compliance instructions, updates and other resources for field personnel
  
  
  

Compliance Partnership Support

• Keep apprised of current and future industry laws, regulations, guidances, trends and other standards and compliance requirements
• Build strong collaborative relationships with key business teams and stakeholders, external vendors, as well as legal and compliance colleagues
• Serve as a compliance resource and provide cross-functional support to Melinta’s business teams and external third-party vendors
• Support management of third-party vendors (e.g., spend transparency vendor) to ensure compliant execution of business activities and strategies
• Support or lead various other compliance projects and initiatives, as assigned
• Maintain Melinta’s compliance program document repository (including compliance policies, supporting procedures, training assets, and guidance documents) and compliance calendar
  
  
  

Qualifications

• A high sense of ethics, integrity, and teamwork
• Minimum of 5 years of experience in providing compliance/operational support to pharmaceutical/biotech companies, with a minimum of 2 years of spend transparency experience
• Excellent project management skills: e xceedingly detail oriented and organized
• Advanced Excel and PowerPoint skills
• Demonstrated ability to work independently
• Ability to multi-task with strong sense of urgency and a commitment to meeting deadlines
• Excellent interpersonal, communication, problem-solving and analytical skills
• Flexible and solution-oriented
  
  
  

Education

• Bachelor's degree required
• Professional certification a plus (e.g. Healthcare Compliance)
  
  
  

Position Type

Full time, New Jersey home office preferred

Travel

As needed, approximately 10% (domestic)

Melinta Therapeutics appreciates your interest in our company as a place of employment. It is our Company's policy to employ, retain, promote, terminate and otherwise treat all employees and job applicants without regard to any individuals’ age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws.