[KOREA] Legal & Compliance Manager
- Full-time
Company Description
Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.
Job Description
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 direct HCP and commercial sponsorship opportunities requested by business based on local pharma code requirements.
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 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.
Legal Support for Key Projects: Provide legal and contract support as requested from Korea 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.
Qualifications
A recognized Law degree preferably Min. 5 - 8 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
Additional Information
Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. 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.
*Please note that team assignments may be subject to future changes