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Sr. Compliance Analyst - CDMX

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Benito Juárez, DF, CMX, MX

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Purpose Statement
Provides legal advice and counsel to a variety of areas, including: regulatory compliance, employment, product liability, contracts, securities, patents, acquisitions, and other areas as needed. Manages litigation and evaluates advisability and strategy of defending or prosecuting claims. Directs outside counsel's preparation of legal documents and handling of litigation. Represents the company in all non-patent related matters.

Key Responsibilities 

  • PSST Reviews/Labeling Review: Review/approve all advertising for IC, PI and Corporate Communications; Act as Legal contact for IC and PI labeling group; Work with attorneys to review and fill out Corp. Form for labeling for patent numbers for all IC and PI labeling; Review/approve all labeling for IC and PI Products.
  • Trademark Administration (mentoring, prosecution, client interaction): Work with marketing on product name generation; Search/clear new product names; Work with outside counsel on trademark prosecution; Work with outside counsel on trademark oppositions; Mentor trademark Paralegals for other divisions and discuss best practices.
  • Contract Administration: Work with attorneys to negotiate agreements; Draft Material Transfer, Joint R&D, Service and Consulting Agreements; Review redlined agreements form other party; Work with HCP team on HCP Compliance for IP Arrangements and coordination with SpendHub; Work with attorneys on issues related to breach of contract and contract maintenance.
  • Assist in implementing and maintaining components of a comprehensive compliance validation program (e.g. audit, monitoring, reviews, etc.).
  • Facilitate and monitor compliance validation efforts, performed by stakeholder groups outside of Global Compliance, associated with Boston Scientific's third parties.
  • Develop and/or enhance Standard Operating Procedures related to processes established to validate compliance and respond/remediate identified issues.
  • Monitor the effective and timely completion of response and remediation activities, escalate delays or inadequacies, as needed, and periodically provide status updates to Management.
  • Generate existing, and support the development of new, metrics/dashboards related to Global Compliance's validation and response/remediation programs.
  • Follow established policies and procedures to support Boston Scientific’s overall business goals.
  • Provides guidance and training to staff, assists staff in attaining career goals, and motivates individuals to achieve results. Provide legal support to specific entities and/or specific projects.

Quality System Requirements 
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Management Requirements 

Knowledge 
A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field.  Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways.  General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position.

Problem Solving 
Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.

Planning and Organization 
Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.

Discretion/Latitude; Supervision Received; Decision Making 
Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions.  Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.

Business Relationships and Project Management 
Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.

Impact 
Contributes to the completion of specific programs and projects.  Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

Liaison 
Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.

Mentoring 
Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

Responsibilities

  • Assist Legal & Compliance Counsel, Mexico & Central America Region, in the implementation and maintenance of BSC Global Compliance Policies and processes, including monitoring risks related to regulations applicable to the medical device industry and other Global Compliance standards and procedures.
  • Assist Legal & Compliance Counsel, Mexico & Central America Region, and the Global Compliance team on continuous improvement and enhancement of the compliance program and culture in Mexico & Central America Region, including in helping to draft and/or revise any compliance working instructions and policies.
  • Review and approve Internal Request Forms (IRFs) for events and activities with Healthcare Providers; Keep close relation and communication with key stakeholders of the IRF process.
  • Participate with Legal & Compliance Counsel, Mexico & Central America Region, in the design and delivery of compliance trainings specific to the regulations and local needs of Mexico & Central America Region.
  • Be responsible for internal compliance monitoring.
  • Provide secretarial support to Mexico and Central America Regional Compliance Committees.
  • Assist Global Compliance, Global Internal Audit and Legal on internal audit and follow-up action plans.
  • Assist with third-party compliance program, including routine compliance audits.
  • Assist Global Compliance on third-party risk assessment and compliance audits of selected distributors and agents.
  • Work closely with Third-Party team on Policies and due diligence.
  • Provide compliance training to distributors and agents.
  • Support the Compliance program by assisting with the creation and maintenance of all materials supporting the Compliance program, e.g. power points, word documents, excel sheets, etc.
  • Support other requests related to the Legal or Global Compliance on as needed basis
     

Education, Experience. Requirements and Competencies:

  • Bachelor’s Degree  in Law
  • Three to five years' experience with internal controls and/or compliance programs (e.g. anti-corruption), preferably in an in-house role and life sciences industry.
  • Customer-focused attitude.
  • Spanish and Advanced English.
  • Excellent oral and written communication skills.
  • Strong attention to detail with good analytical skills.
  • Excellent organization and planning skills.
  • Ability to handle multiple activities successfully.
  • Self-motivated. Good judgment - fair and objective.

 

Requisition ID: 540450

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


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