Director of Compliance leading compliance initiatives across the US Commercial organization at Organon. Implementing tools and processes to drive compliance and risk management initiatives.
Responsibilities
Lead the implementation and coordination of compliance program initiatives across the US Commercial organizations and related functions.
Coordinate cross-functional stakeholders to implement regional compliance initiatives ensuring consistent implementation of compliance processes.
Manage timelines, deliverables, and compliance program milestones.
Oversee planning and coordination of compliance training relating to the US Commercial and related functions including managing the regional compliance training plan and training calendar.
Coordinate development, rollout, updates and revisions of regional general compliance training programs in collaboration and with input from compliance business counseling colleagues, ensuring that compliance guidance and policies are incorporated into US Commercial and related functions’ training materials.
Coordinate development, revisions and communication of compliance policies and guidance relating to US Commercial and related functions, including ensuring policy updates are communicated effectively to relevant stakeholders and the integration of new guidance are incorporated into compliance training and communications.
Coordinate key activities associated with regional compliance monitoring activities including supporting the development of monitoring plans, and tracking monitoring activities and outcomes.
Support in country monitoring follow-up actions and remediation activities, and support reporting of monitoring activities to leadership.
Coordinate activities supporting the regional compliance risk management framework including maintaining tracking of identified compliance risks and mitigation plans, coordinate follow-up activities relating to risk mitigation and support reporting and documentation related to compliance risk management.
Coordinate governance activities supporting the US compliance program including managing compliance committee processing, including tracking committee action items, and supporting implementation of committee decisions across the organization.
Provide support as needed to compliance related programs processes such as Fair Market Value, third party due diligence, proactive monitoring follow up, promotional material review process, and field sales related communication activities.
Lead the development of tools, templates and frameworks supporting US related compliance activities; standardize workflows and documentation processes.
Identify opportunities to improve coordination and program execution leveraging technology, such as AI.
Develop dashboard and reporting capabilities relating to US related compliance initiatives, tracking program milestones and deliverable.
Provide proactive identification of compliance risks and gaps and take the lead in developing solutions.
Requirements
BA/BS required; advanced degree in compliance, business, or law preferred.
At least ten plus years of business experience with previous compliance experience in the pharmaceutical industry required.
Experience working with risk management frameworks and related systems in compliance preferred.
Strong capability in synthesizing complex information into clear insights and actionable steps.
Strong project and program management capabilities required.
Ability to manage multiple projects simultaneously and prioritize activity in alignment with business goals and compliance requirements.
Understanding of federal and state compliance laws and regulations, industry codes of conduct (e.g. Pharma Code, OIG Compliance Program Guidance).
Ability to coordinate and lead cross-functional stakeholders (sales, R&D, IT, marketing, data analytics, privacy, AI, and cybersecurity, and manage complex initiatives).
Experience implementing technology, compliance tools and systems including AI tools.
Experience with developing ongoing metrics, dashboards, reports, presentations for senior leadership and business reporting.
Ability to translate and communicate complex concepts clearly.
Strong written and verbal communication skills.
Demonstrated ethical mindset and integrity; ability to exercise sound judgment and to influence at every level of the organization.
Benefits
retirement savings plan
paid vacation and holiday time
paid caregiver/parental and medical leave
health benefits including medical, prescription drug, dental, and vision coverage
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