Legal & Compliance Lead (Mexico - CENCA)

Job Description

The Position

As a trusted partner within the Organon Legal &Compliance team you will partner with our leaders to ensure we maintain Organon’s values and high ethical standards, protect our people and assets, and enhance our reputation. You will be part of a senior team that promotes and exhibits teamwork, collaboration, trust and a supportive environment across the organization.

The primary responsibility of the Legal / Compliance Lead is to protect the legal and compliance interests of Organon Mexico and Central America businesses by handling or overseeing the handling of all legal and compliance matters arising from those subsidiaries under the supervision of the Regional LAMERA Counsel and in collaboration with other divisional counsel and Business Practices Officers and external local firms & counsels, as well as relevant Legal and Compliance headquarters staff, subsidiary and other functional groups.

In particular, the Legal/Compliance Lead is responsible for monitoring activities which require legal and compliance input and ensuring that the appropriate advice is given either by the Organon Legal/Compliance staff or by our external resources.

The Legal/Compliance Lead will ensure that the Company complies with all legislative requirements including anti-corruption/anti-bribery, fair competition, antitrust legislations and privacy etc., as well as local business standards and industry regulations.

The Legal/Compliance Lead will also oversee all elements of an effective comprehensive compliance program (governance, standards, training, communication, monitoring, investigations, remediations and continuous improvement), and partner with businesses leaders and local Business Practices Officers to assess risks and provide guidance, tools and resources to support business ownership and accountability for implementation of strategies and activities that are consistent with the Company code of conduct and policies.

The Legal/Compliance Lead will also assess, supervise and manage the external legal counsels within the Mexico-CA, ensuring advice is timely, cost-effective and of consistently high quality. The Legal/Compliance Lead will report to and support the LAMERA Regional Counsel, and as needed liaise with attorneys and compliance officers in other areas of Organon & Co, to seek advice and to provide updates on legal matters.

Responsibilities

The Legal & Compliance Lead’s primary responsibility is to protect the legal interests of Organon and its personnel by handling all legal and critical compliance matters arising in Mexico- LATAM, along with leading select regionwide legal initiatives. And to keep local Business Management apprised of significant legal, compliance and corporate developments and trends in support of Company business.

Management, control and oversight of all legal issues, including but not limited to:

Commercial and Contractual Matters

• Provide legal guidance on all commercial activities, including tenders/market access matters, and business undertakings.
• Draft, review and negotiate commercial agreements.
• Advise on commercial/corporate and labour issues and negotiate with external parties on behalf of the Company, where needed or appropriate.
• Advise on competition law, and help shape appropriate pro-competitive programs and offerings, in line with the Company’s policies and standards.

External Counsel Management:

• Supervise and manage external legal counsel and legal expenditure in accordance with Company guidance.

Regulatory Matters:

• Monitor changes and developments in the legal and regulatory environment within which the company operates, advise management and develop appropriate strategies.
• Prepare and review communication with external parties, including the government, industry association and the public in relation to healthcare legislations/policies and disease awareness campaigns.
• Provide advice and legal support on application and maintenance of all authorizations, permits and licenses needed for local operations, including importation, manufacturing and marketing of products, conducting clinical trials and implementing product recalls where needed.

Promotional Review:

• Provide internal legal review as part of promotion process for marketing/promotional programs and initiatives, according to local laws and Company standards.

• Initiate and respond to regulatory/competitor challenges on questionable promotions.

Disputes/Litigation/Government Inquiries/Investigations

• Disputes/Litigation: Initiate, defend, and manage all litigation and disputes arising from business operations, including adverse reaction/product liability claims and regulatory challenges.
• Manage, support, advise, report on and respond to government inquiries and investigations relating to the business operations, in collaboration with regional/HQ management of the Office of General Counsel, local management and other functional stakeholders as appropriate.

Intellectual Property

• Liaise with Organon’s in-house and external IP attorneys to coordinate local trademark and patent filings and collect and disseminate intellectual property information for local management, as needed.
• Monitor and assist local strategies and counteractions in relation to local IP infringement actions, in consultation with Organon’s IP attorneys in headquarters.

Labor and Personnel Issues

• Advise on sensitive personnel situations, prepare and review legal documentation as required, e.g. employment and separation agreements, releases.
• Support the planning/implementation/monitoring of Company strategies to effect entity planning and restructuring as needed.

Company Secretarial Matters

• Oversee Company Secretarial matters and ensure compliance with local regulatory requirements
• Maintain all corporate records for local subsidiaries within the Mexico-LATAM.

Compliance and Business Practices Standards

• Partner with Business Practices Officers to develop compliance objectives and priorities to help ensure there is effective compliance program; advise internal teams on legal and compliance issues and work with them to address risks and find solutions.
• Support the training of the local Business Practices personnel.
• Work with the Leadership Teams as well as related stakeholders to conduct risk assessment, develop compliance program strategy, goals and objectives that risk based and align with business and global strategy, goals and objectives.
• Support implementation of an effective compliance programs by the local BPO’s as well as address and mitigate compliance risks and promote culture of ethics within the assigned countries together with the local BPO’s.
• Work with business partners and local Business Practice Officers to maintain, update and create appropriate compliance SOPs that align with global policy and local Codes.
• Work with cross functional team and local Business Practice Compliance Officers to build compliance controls, compliance related systems and processes, integrate compliance requirement in business operation processes and systems.
• Staying current with the business and industry and provide guidance on complex compliance related issues / high risk programs reviews.
• Support compliance monitoring tools and follow up processes to help the business pro-actively identify potential compliance issues/risks and work with related stakeholders to address the potential compliance risks in a timely and through manner.
• Work with compliance investigation COE team to provide input on tier 1 cases and help oversee tier 2 compliance investigation within the different countries.
• Support Compliance Committee to ensure ongoing review of compliance related initiatives and risk mitigation actions including achieving compliance goals.
• Support use of data monitoring tools to strengthen and efforts to expand data analytics aspects of proactive monitoring program.
• Work with local Business Leadership and Business Practice Compliance Officers to support Implementation/localization (whenever necessary) global compliance policies/initiatives/programs/systems and ensure delivery of value added to business as well as risk control and monitoring.
• Build and maintain contacts at peer companies within Mexico-LATAM countries to improve and exchange best practices.

Required Education, Experience and Skills

• Admitted to practice law in Mexico or another Latin American jurisdiction.
• Minimum 8 years post qualification legal and compliance experience in a multinational company, preferably in the pharmaceutical and consumer industries.
• International experience is required.
• Professional or academic legal qualification or experiences in Mexico, LATAM and Caribbean Countries desirable.
• Additional degrees in science or business disciplines would be advantageous.
• In-house experience in a multinational organization; and/or experience in a top tier law firm.
• Willing and able to travel domestically and internationally.
• Fluency in speaking and writing in English and Spanish
• Identify key issues and consistently apply a high standard of integrity, professionalism, legal knowledge and expertise and business ethics
• Provide practical and value-added legal advice
• Influence cross-functional teams and senior management in the business
• Proactive, pragmatic and responsive.  

Secondary 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 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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

Search Firm Representatives Please Read Carefully
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.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

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

Employee Status:

Relocation:

VISA Sponsorship:

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R525211