Associate Director, Legal & Compliance – Vietnam & Thailand

MSD

  • Tp Hồ Chí Minh
  • Lâu dài
  • Toàn thời gian
  • 1 tháng trước
Job DescriptionPOSITION OVERVIEW:The Associate Director, Legal & Compliance – Vietnam & Thailand shall have the primary responsibility to provide legal and compliance advice and protect the legal interests and compliance standards of all our company businesses (e.g. Global Human Health and Animal Health), divisions and functions across Vietnam and Thailand (collectively referred to as the “Markets”), supporting the Director, Legal & Compliance. The successful candidate will be a member of the respective Country Leadership Teams in the Markets.The position will be based in Ho Chi Minh City, Vietnam.The successful candidate will handle legal and compliance matters arising from our company businesses in the Markets or as designated by and under the supervision of the Director, Legal & Compliance. In addition, as a member of the Asia Pacific Legal and Compliance team, the successful candidate needs to work closely with the Human Health Business Practice Officers (“BPOs”) in the Markets, as well as other members of the Asia Pacific Legal and Compliance team, colleagues from the Office of General Counsel and the Ethic and Compliance Office, external counsel and relevant headquarters and subsidiary staff and functional groups, as needed.PRIMARY SCOPE OF WORK:Primary scope of work includes, but is not limited to the following:Supporting the legal and compliance needs of all key stakeholders in the relevant areas of law which may include but is not limited to privacy, anti-corruption/anti-bribery, fair competition, and trade practice legislations, etc. as well as our company’s policies, compliance standards and local industry guidelines. In particular:Commercial and Contractual Matters
  • Advise on day-to-day commercial transactions and business undertakings
  • Advise on business development, marketing and business initiatives, patient programs, review and draft/negotiate related agreements
  • Advise on commercial/corporate and employment issues and negotiate with external parties on behalf of our company, where needed or appropriate
  • Advise on innovative solutions with a particular interest in patient programs, digital, technology and data-analytics
Regulatory Requirements
  • Monitor changes and developments in the legal and regulatory environment within which our company businesses operate, advise local management and develop appropriate strategies
  • Provide advice and legal support, as needed and in collaboration with regulatory affairs, on application and maintenance of all authorizations, permits and licenses needed for local operations, including importation, listing/reimbursement and marketing of products, conducting clinical trials, handling adverse experience incidents and implementing product recalls where needed
  • Support our company in interactions with regulatory and other relevant government agencies on legal and compliance issues and development of appropriate strategies for resolution of issues
Promotional Review
  • Provide and/or oversee internal legal review as part of our company’s medical-legal process for promotional materials according to local laws and our company policies and standards
  • Collaborate with Medical and business colleagues in initiating and/or responding to regulatory/competitor challenges on promotional practices
Business Standards & Compliance
  • Develop, monitor and implement compliance and risk management strategies and processes, and work with divisional compliance and local BPOs and management.
  • Where appropriate, conduct legal & compliance training; monitor and resolve legal & compliance issues, work with local management to formulate and implement appropriate local business standards and procedures consistent with local laws, US laws (including the US Foreign Corrupt Practices Act (FCPA)), industry standards (including local pharmaceutical industry Codes of Conduct and the International Federation of Pharmaceutical Manufacturers Association (IFPMA) Code of Marketing Practices) and corporate policies.
Disputes/Litigation
  • Support the initiation, defence, negotiation, settlement and management of litigation, disputes and actions arising from business operations of our company, including contractual, IP, adverse reaction claims, compliance and regulatory challenges, in collaboration/consultation with regional legal team and other legal colleagues from headquarters or other divisions as appropriate
Intellectual Property
  • Support our company’s headquarters IP attorneys to coordinate with local external counsel as needed on local trademark and patent filings and collect and disseminate intellectual property information for local management
  • Provide advice on local strategies and counteractions in relation to local IP infringement and enforcement actions, in collaboration with our company’s global IP attorneys
Human Resources Issues
  • Advise on sensitive HR/Labor law-related issues
  • Participate in internal investigations remediation team and provide legal and compliance perspectives, as appropriate
Others
  • Conduct internal investigations, where necessary, in collaboration with Global Security, Global Investigations and Office of Ethics, and coordinate with Corporate Audit, local management and Finance/HR groups in taking practical and appropriate remediation actions as needed
  • Additional responsibilities and projects may be assigned by the Director, Legal & Compliance on an ad-hoc basis
  • Participation in meetings of Country Compliance Committee, Local Review Boards, Grants Committee and other compliance or country-level leadership committees in the Markets, as needed/designated by line management
  • Collaborating and instructing external counsel where needed and to provide inputs and oversight of the work done by external counsels
WHAT WILL A SUCCESSFUL APPLICANT LOOK LIKE?QualificationsMust have:
  • A degree in law or the equivalent
  • Admitted to practice law in Vietnam
  • 7-10 years of post-admission experience
Skillsets
  • Strong language proficiency in English required
  • Ability to manage the Markets largely independently of the Director, Legal & Compliance
  • Ability to quickly distil and effectively communicate corporate (HQ) cascaded compliance positions and policies to the local markets.
  • Ability to identify legal/compliance risks vs business risks and provide counsel to local market leadership on such risks
  • Ability to communicate confidently and effectively with market leadership teams
  • Ability to appropriately challenge the status quo whilst understanding the fundamental legal principles and our company’s standards at the enterprise level
  • Ability to provide practical and commercially focused solutions whilst consistently applying a high standard of integrity, professionalism, legal knowledge, and business ethics
  • Ability to understand and balance local market needs with enterprise level principles and direction
  • A positive personality and ability to thrive in a fast-changing, pressurizing and highly regulated environment
  • Proactive and responsive
  • Strong communication and interpersonal skills
Knowledge & ExperienceThe following experience is required:
  • In-house legal and compliance experience in a multinational organization; and/or
  • In-house legal and compliance experience in a pharmaceutical company or other highly regulated industries (e.g. biochemicals, medical devices industry) ; and/or
  • Commercial practice experience in a top tier law firm
The following experience is highly preferred:
  • Private practice experience in advising the pharmaceutical industry or other highly regulated industries (for e.g. biochemicals industry)
  • Familiarity with the US FCPA, the IPMG Code of Conduct, the IFPMA Code of Marketing Practices and local pharmaceutical related laws, regulations and codes of conduct in the Markets would be advantageous
  • Ability to proficiently advise on and apply the following to local business operations/practices:
Vietnam:
  • Commerce Law (as it relates to the activities of representative offices)
  • Decree 117 (Administrative Violations)
  • Pharmacy Law
  • Decree 54/2017 (Guideline for implementation of the Law on Pharmacy)
  • Decree 14/2023 (privacy)
  • Relevant Labor regulations in the Markets
Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):

MSD

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