Director, Compliance - HYBRID

Job Description

The Position

Organon is recruiting for a Director, US Compliance to provide business counseling support for the US Commercial Organization, for pharmaceutical and medical device products. The role is focused on marketing and sales support and also supports other functions, as needed.

The Director, US Compliance will support client teams with the effective execution of compliant business practices, by partnering on setting and consulting on policies, providing training and best practices, promoting compliant behaviors, raising issues, and supporting corrective actions.

Responsibilities

• End-to-end compliance support to business teams including marketing and sales personnel. 

• Understanding the business needs, strategic objectives, and operational practices of the client organizations. 

• Provide launch support for marketing and sales teams.

• Oversight and monitoring planning and support.

• Assigned points for certain Ethics and Compliance-owned policies.

• Cross-functional team support, as needed.

• Providing subject matter expertise in the relevant guidance, policies, codes, and regulations, as well as in their applications to the business—including familiarity with the following: the U.S. anti-kickback statute, State gift laws, fundamentals of U.S. pharmaceutical and medical device product promotion regulation, the PhRMA Code on Interactions with health care providers (HCPs), and the AdvaMed Code of Ethics on Interactions with Healthcare Professionals.

• Applying subject matter expertise in advising and counseling clients on new issues, answering routine questions regarding policy, and assisting in the assessment and implementation of new activities.

• Assisting in the development and communication of compliance objectives and initiatives to US business stakeholders.

• Maintaining full line-of-sight (from strategic intent through tactical execution) when supporting line managers with the development of new or refined guidance to ensure that they are relevant, appropriate, and implementable.  Steps include gathering input, authoring, circulating drafts, gaining necessary approvals, developing communications plans, and integrating the guidance into new or existing training.

• Utilizing brand knowledge, review materials as part of the Promotion Review Team.

• Providing proactive identification of compliance risks and gaps and leading the development of solutions.

• Developing strong working relationships with key stakeholders in business partner areas, and throughout the compliance organization and legal organization. 

Required Education, Experience and Skills

• BA/BS required; advanced degree in business, marketing, law, audit or public policy preferred.

• Demonstrated ethical mindset and integrity; ability to exercise sound judgment and to influence.

• At least eight years Compliance experience with at least five years pharmaceutical experience.

• Previous experience as compliance business partner supporting Sales/ Marketing functions in the pharmaceutical industry.

• Up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct (e.g. Pharma Code, OIG Compliance Program Guidance)

• Familiarity with sales or marketing organizations and activities, as well as medical affairs organizations and activities.

• Experience with the development or execution of written policies, guidance, laws, rules or regulations or other significant drafting or writing experience.

• Training and presentation experience in individual or group situations.

• Experience in Risk Management
• Self-motivated and proactive

• Experience/comfort working with senior managers, and Legal organizations.

• Ability to influence and exercise good judgment.

• Ability to apply knowledge to real world situations.

• Ability to translate and communicate complex concepts clearly.

• Ability to manage multiple projects simultaneously and prioritize activity in alignment with business goals and compliance requirements.

• Strong judgment and decision-making skills regarding compliance related topics.

• Strong written and oral communications skills.

Secondary Language(s) Job Description

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 p