Director, Compliance Operations

Conshohocken, PA
General Counsel /
Full Time /
Hybrid
The Director, Compliance Operations is responsible for assisting the Global Compliance Officer and the Chief Compliance Officer with the implementation and management of Madrigal’s U.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 application of best practices in the life sciences Compliance space. This role requires significant interaction with Sales and Marketing, Legal, Information Technology, Market Access, Medical Affairs, and other functions.

Essential Functions Of The Job (Key Responsibilities)

Work with other members of the Compliance and Legal team to maintain and enhance 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

Assist with managing U.S. Compliance Committees to track compliance efforts and initiatives and project status updates

Participate in routine meetings with U.S. business partners

Participate in the review and approval process of certain core U.S. business activities (e.g., Sponsorships, Advisory Boards, Healthcare Professional engagements, etc.)

Partner with other members of the Compliance and Legal team to identify policy/guideline needs, develop/enhance policies and guidance documents, and ensure optimal accessibility for the U.S. Business

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

Develop and implement tools to empower business stakeholders to make ethical and compliant decisions

Provide guidance to the U.S. Business and integrate compliance controls into the scope of existing business practices where applicable

Develop, lead, and implement continuous improvement activities, including managing documentation and tracking compliance activities

Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws

Other duties and special projects as assigned

Qualifications (Minimal acceptable level of education, work experience, and competency)

Bachelor's degree required

Minimum of 10 years of pharmaceutical/life sciences compliance 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

Ability to travel up to ~25% including overnights and weekends as needed for business meetings and field monitoring activities