[VN/TH] Legal & Compliance Manager

Company Description

Santen is a specialized company with a proud 130-year heritage focused exclusively on eye health. As a Japan-originated, global company with our footprint in over 60 countries and regions, our mission is to provide essential and significant value to patients and society through our products and services created from our expertise in opthalmology and from the patient’s perspective.

This position is intended to be Legal and Compliance subject matter expert for Vietnam and Thailand while based in Vietnam and manage day-to-day operational tasks with limited oversight. This position should understand local business goals and operations, identify legal and compliance risk areas, analyze key legal and compliance implications and autonomously devise functional plan for business adoption to ensure compliant and smooth operation.

Job Description

What you will do

• HCP engagements:
  - Services: Reviewing proposed HCP service engagement, approving remuneration to be paid to HCPs based on local pharma code requirements and reviewing HCP service agreements. Providing guidance on acceptable hospitality which can be offered to HCPs.
  - Sponsorships: Reviewing sponsorship opportunities requested by business based on local pharma code requirements.
• Promotional Material Review: Reviewing external-facing promotional material to highlight potential issues and provide recommendations to ensure compliance. Marketing Communication: Reviewing marketing strategies, and product-related or other promotional communications.
• Compliance Policy and Guidelines: Reviewing, recommending changes or creation, and implementing compliance related policies and guidelines to close any business gaps. Compliance Training: Planning and conducting annual compliance training for local company employees and provide additional training, as necessary for any new updates in local regulations. Compliance Auditing and Monitoring: Planning and managing audits for compliance risk areas, with external resources as needed. Compliance Guidance: Fact-finding and analysis, providing guidance and propose solution for business alignment. Occasional support from external resource maybe requested for complicated issues which require analysis of local laws implication. 
• Contract Management: Professional and efficient contract services that are continuously provided to the business functions, including but not limited to 1) reviewing day-to-day HCP-related agreements; 2) contract drafting, review, and negotiation services; 3) develop and update contract templates/forms as appropriate for current business activities of the company. For significant contracts, provide updates and align as necessary with Asia Legal. 
• Legal Support for Key Projects: Provide legal and contract support as requested from Vietnam and Thailand management (such as providing advice on applicable laws and regulations, contract reviews and negotiations). For significant legal matters, escalate as necessary to Asia Legal for further actions. Legal Analysis and Advice: Provide client functions with analysis, guidance, support, advice and solutions regarding legal and contract matters associated with the company’s business activities. For significant legal matters, escalate as necessary to Asia Legal.
• New legislation: Stay abreast of evolving legislation, regulations, and the enforcement landscape with respect to legal subject matter expertise (e.g. FIE, privacy data protection), and provide updates to colleagues in the legal function and management. Implement countermeasures to comply with such legislation as needed.
• Data Privacy Matters: Implement data protection measures and manage personal data protection-related queries and complaints with guidance from Asia Legal.
• Others: Performing other duties as assigned by functional lead or management.

Qualifications

What you will bring to the role

• A recognized Law degree and admission to the Vietnam Bar or a common law jurisdiction, preferably someone with minimum 6 years of experience serving in a compliance, legal, regulatory or related role in the pharmaceutical/medical device industry; and preferably with healthcare compliance certification (CHC)
• Experience with handling legal matters including drafting and reviewing contracts in a corporate legal department (in-house or within a law firm) within the healthcare industry
• Ability to interpret laws and regulations and analyze case law
• Established knowledge and understanding of healthcare industry laws, regulations and guidelines involving anti-bribery and anti-corruption, HCP/patient interactions, promotional material regulations
• Thorough functional knowledge of the elements of healthcare compliance program and thorough knowledge and understanding of the healthcare industry
• Demonstrated ability to identify, assess, and prioritize higher risks versus lower risks
• Demonstrated ability to take gray areas/ambiguity in the laws/regulations or complex new areas and provide recommended courses of action to senior management
• Ability work efficiently as a strong business partner and collaboratively with others in the legal and compliance department as well as internal functions with a focus on collaboration and delivering results
• Fluency (both spoken and written) in English and local language (Vietnamese as a priority) is a must to ensure that he/she can effectively communicate with regional and local teams and understand local language documents

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of “Happiness with Vision” by providing eye health products and services to patients, consumers, and medical professionals around the world. Guided by our CORE PRINCIPLE, “Tenki ni sanyo suru”, Santen is engaged in the global research & development, manufacturing, and sales and marketing of pharmaceutical products in opthlamology. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.