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MSD Associate Director Legal & Compliance – Vietnam 
Vietnam, Ho Chi Minh City 
546856643

Yesterday

Job Description

POSITION OVERVIEW:

The position will be based in Ho Chi Minh City, Vietnam.

PRIMARY SCOPE OF WORK:

Primary scope of work includes, but is not limited to the following

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

Must 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 & Experience

The 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 Contingent Workers apply


Hazardous Material(s):


Job Posting End Date:06/03/2024


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