Senior Manager Compliance

at  Melinta Therapeutics LLC

SENIOR MANAGER, COMPLIANCE

If you want to be a part of a team that is passionate and dedicated to saving lives threatened by the global public health crisis of infections, then Melinta Therapeutics might be the right place for you. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge and flexibility are valued.
Melinta provides innovative therapies for acute and life-threatening illnesses, with commercial and medical capabilities, specializing in infectious diseases and acute care. We have experienced hospital Sales and Value & Access teams throughout the US, and a Medical Affairs team with clinical and practical experience in acute care. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business.
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.

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 knowledge 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

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: exceedingly 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)

JOB PURPOSE

The 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.

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 knowledge 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 pla