Legal & Compliance Associate Director

Job Description

The Legal & Compliance Assoc. Director’s primary responsibility is to protect the legal interests of Organon and its personnel by handling all legal and critical compliance matters arising in Portugal, 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.

This role is responsible for management, control and oversight of all legal issues in close collaboration with the Spain & Portugal Legal Director, 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 associations and the public, in relation to healthcare legislation/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 the 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, and releases.
• Analyse and propose legal perspective in the design of employment strategy, compensation and talent initiatives.
• Support the planning/implementation/monitoring of Company strategies to effect entity planning and restructuring as needed.

Company Secretarial Matters

• Oversee Subsidiaries Secretarial matters and ensure compliance with local regulatory requirements.
• Maintain all corporate records for local subsidiaries within Portugal.

Compliance and Business Practices Standards

• Partner with Business Practices Officers (BPOs) 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 BPOs.
• Work with the Leadership Teams as well as related stakeholders to conduct risk assessments, and to develop compliance program strategy, goals and objectives that are risk based and align with business and global strategy, goals and objectives.
• Support implementation of an effective compliance program by the local BPOs as well as address and mitigate compliance risks and promote a culture of ethics within the assigned countries together with the local BPOs.
• Work with business partners and local BPOs to maintain, update and create appropriate compliance SOPs that align with global policy and local codes.
• Work with cross functional teams and local BPOs to build compliance controls and compliance related systems and processes, and to integrate compliance requirements into business operation processes and systems.
• Stay 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 thorough manner.
• Work with the Compliance Investigation team to provide input on Tier 1 cases and help oversee Tier 2 compliance investigations within Portugal.
• Support the local Compliance Committees to ensure ongoing review of compliance related initiatives and risk mitigation actions including achieving compliance goals.
• Support use of data monitoring tools to strengthen efforts to expand data analytics aspects of a proactive monitoring program.
• Work with local Business Leadership and BPOs to support implementation and localization (when necessary) of global compliance policies/initiatives/programs/systems and ensure delivery of value adds to the business as well as risk control and monitoring.
• Build and maintain contacts at peer companies within Portugal to improve and exchange best practices.
• Provide legal support and strategic guidance on privacy issues working together with the BPO.

Secondary Language(s) Job Description:

Qualifications

• Qualified to practice law in Portugal
• Fluency in speaking and writing in English and Portuguese. Spanish is an asset.
• Minimum 6 years post qualification legal experience in a company or a top tier law firm in Portugal, preferably in the pharmaceutical, medical device or consumer care industries
• Compliance experience is preferred
• Multinational/international experience is preferred
• LLM or postgraduate studies is advantageous

Skills

• Ability to identify key issues and consistently apply a high standard of integrity, professionalism, legal knowledge and expertise and business ethics
• Ability to provide commercially focused and value-added legal advice
• Strong drafting and negotiation skills
• Ability to design, implement and administer compliance programs and procedures
• Very strong communication skills, both verbal and written
• Ability to work independently and prioritize work under pressure
• Ability to work autonomously as well as within a team environment
• Ability to deal with a broad range of people across all levels
• Ability to influence cross-functional teams and senior management
• Proactive, responsive, and a practical approach with a sense of humor

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.

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R511119