Director, Compliance - Hybrid

Job Description

The Position

Organon is recruiting for a Director, Compliance to lead key elements of the US compliance program infrastructure supporting the US Commercial organization and related functions. This role will coordinate the US Commercial organization and related functions’ role-specific training, policy management of US Commercial policies, regional and in country monitoring activities and remediation, governance processes and provide risk management support.

The Director, US Compliance will ensure compliance priorities are translated into structured programs, processes and governance activities that drive consistent implementation across the US Commercial organization and related functions.  The Director works closely with global compliance ops team, compliance business counseling, US commercial leadership (including US Commercial Head) and cross functional stakeholders to manage program initiatives, and overall effectiveness of the compliance framework.

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.

Required Education, Experience and Skills

• 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.

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Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

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Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

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Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Applicable to United States Positions Only:  Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job.  Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience.  The applicable salary range for this position in the U.S. is stated below.  Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

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Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

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