Role Overview

Exeltis is seeking an experienced healthcare compliance professional to take a role in designing, implementing, building, and maintaining an effective US healthcare compliance program and developing a culture of compliance in the organization. This individual will support a growing business and shape the company culture to achieve the company's goals and objectives in a compliant and ethical manner. The ideal candidate will work across the business to set the tone and trajectory of the compliance program while meeting applicable healthcare-related laws, rules, regulations, guidance requirements, and internal policies.

Primary Duties & Responsibilities

• Key contact point for US compliance
• Chair and oversight of the Compliance Committee
• Serve as the Company Compliance Officer
• Develop strategies for, and oversee day-to-day operations of, Exeltis' compliance and ethics program
• Develop, update, and execute implementation of right-sized policies, procedures, and ways of working
• Staying current with relevant rules and regulations
• Develop training programs and communications to help employees understand their role in maintaining a compliant and ethical organization
• Proactively identify compliance risks, opportunities and mitigating actions
• Create, update, and manage a risk-based compliance auditing program, including monitoring of commercial activities, ride-along with sales representatives, and review of HCP interactions, drug sample accountability, etc.
• Manage investigations into possible violations of applicable laws, rules, regulations, and policies and recommend a corrective and preventive action plan (CAPA).
• Manage and coordinate with internal stakeholders, vendors, and third parties on federal and state transparency (Aggregate Spend) and transfer of value (gift bans) reporting, field representative registration, sample accountability, and compliance program reporting requirements.
• Ensure timely submission of aggregate reports and required disclosures
• Fair Market Value (FMV) assessment for healthcare professionals (HCP)
• Subject matter expert providing advice on compliance matters including but not limited to, labelling, marketing strategies, promotional tactics and materials, advertising campaigns and programs, patient support programs, customer interactions, HCP engagements, and commercial sponsorships.
• Compliance oversight of investigator-initiated trials (IITs), advisory boards, and speaker programs.

Competencies/Career level

Please list all that apply: Innovation, entrepreneurial attitude, customer orientation, team leadership, adaptability/flexibility, results-oriented, control of budgets/costs, Self-development.

Requirements and personal skills

• Education: Bachelor's degree required; JD, MBA, MPH, or Master's in a related field preferred
• Languages: English
• Experience (years/area): 7 to 10 years' related experience in a biotechnology or pharmaceutical company. Tactical, operational, and strategic capability is preferred
• Specific Knowledge and abilities: Broad knowledge of US compliance and data privacy laws and standards, including but not limited to Open Payments Sunshine Act, OIG HHS Compliance Program Guidance, PDMA, HIPAA, and GDPR.

State level privacy, compliance and transparency laws.

Federal False Claims act, Federal anti-kickback statute, PhRMA Code.

Demonstrated ability to lead teams, influence stakeholders, and manage complex compliance issues.

High ethical standards and sound judgment.

Physical Demands

This job operates in an office based professional environment. This role routinely uses standard office equipment such as computers, phones, printers, etc.

Travel: 25%

Position Type and Expected Hours of Work: This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee:

• Is required to interact with internal and external contacts independently
• Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable.
• Is often required to stand, walk, bend, lift, or sit.
• Is required to occasionally lift office products and supplies, up to 40 lbs.
• Is desk-based and may be sitting for long periods of time.
• Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
• Must communicate clearly: phone calls, emails, in-person conversations
• Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive functions.