Overview

Job ID 19000CUC

Available Openings 1

PURPOSE AND SCOPE:

The VP Associate General Counsel – Products Regulatory acts as the primary manager of legal support for medical products regulatory issues, including FDA regulation of medical devices, pharmaceuticals and biologics, clinical research, pharmacy law, and general healthcare law and regulation relating to FMCNA’s healthcare products, leading a team of attorneys and paralegals. Provide practical, business-oriented strategic advice and counsel to help the company meet its business objectives through an in-depth understanding of the laws, rules and regulations applicable to FMCNA business, including FDA law and regulation, clinical research rules, pharmacy law and regulation, federal and state anti-kickback statutes, anti-self-referral statutes, false claims statutes, Sunshine Act, HIPAA/HITECH, and the CMP statute. Maintain a thorough understanding of the company’s business objectives and acts as a trusted business partner for senior management and the organization.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Utilizes subject matter expertise in the areas of business law, healthcare law and compliance to support the business. Builds coalitions and contributes to strategies based on an understanding of external and internal landscape.
  • Represents the company in interactions with federal and state regulatory agencies.

    • Reviews and advises on programs, initiatives, and contracts related to purchasing, sales, marketing, reimbursement, and various other business transactions.
  • Reviews and advises on promotional materials and corporate communications.
  • Provides project management, due diligence and integration support in connection with business development transactions.
  • Maintains current knowledge of all significant legislative and regulatory developments that may affect the company in the areas of healthcare and business law. Communicates changes in legislation and regulation to the organization as is appropriate.
  • Establishes and maintains positive supportive relationships with business unit management and personnel at all levels. Provides a variety of legal counsel and support to functional and/or operational groups within the company.
  • Provides day to day guidance, support, training and assistance to staff in the legal department, providing oversight support, mentoring assigned staff, and collaborating with them to develop objectives and goals for the department and also as part of continued career development and advancement within the organization.

    • Oversees departmental workflow procedures and service levels. Reviews ongoing analysis and assessments of performance.
    • Provides informal feedback on an ongoing basis and formal feedback in the annual performance evaluation process, counseling and working with the staff member to establish individual short term and long term performance goals.
    • Manages the staffing through the appropriate hiring, firing and disciplinary actions in collaboration with Human Resource partners.
    • Develops, implements and maintains departmental processes and procedures to enhance the overall efficiency of the department.
  • Manages external legal counsel and other outsourced resources involved in key company projects to optimize project outcomes.
  • Assist with various projects as assigned.
  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISION:

  • May be responsible for the direct supervision of various levels of legal staff.

EDUCATION:

  • Juris Doctorate degree from an accredited college or university required.
  • Admitted to practice in the Commonwealth of Massachusetts or another US state.
  • Master of Public Health or Master of Business Administration preferred.

EXPERIENCE AND REQUIRED SKILLS:  

  • 15+ years of experience practicing law, either at a law firm, in house or a combination thereof.
  • 10+ years (of the 15+ years) of experience practicing law in the healthcare industry, either at a law firm, in house, or a combination thereof, advising on healthcare fraud and abuse laws, and/or other laws related to the delivery of healthcare services and products.
  • Detail-oriented with very strong oral and writing skills.
  • FDA regulation of medical devices, pharmaceuticals, and biologics, clinical research, pharmacy law, and general healthcare law and regulation required.
  • In-house experience with a healthcare provider or medical product manufacturer preferred.
  • Experience managing legal professionals preferred.
  • Able and willing to lead key initiatives and participate in teams driving key decisions preferred.
  • A strong intellect and solid business acumen, coupled with the skills of a pragmatic business leader preferred.
  • Superior communication and interpersonal skills and demonstrated success in the ability to relate to many different constituencies preferred.
  • Highly developed strategic and conceptual/analytical skills preferred.
  • Ability to work in a fast-changing, intense working environment.
  • Makes decisions with a sense of urgency, prioritizing possibilities and opportunities, and balancing information seeking with acting quickly.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity


ADDENDUM:
Products Regulatory

• Support RTG, NxStage, Frenova, RRI, FreseniusRX, and other FMCNA business units in products regulatory issues relating to FDA, clinical research, pharmacy, and general healthcare law and regulation.
• Advise RTG, NxStage and other FMCNA business units on FDA strategy and tactics regarding premarket submissions (510(k), NDAs, etc.) and postmarket compliance (Quality System Regulation (QSR), Good Manufacturing Practices (GMPs), etc.).
• Advise all FMCNA business units on FDA-related issues, including interactions among divisions that implicate FDA law and regulation.
• Serve as legal representative on Promotional Materials Review Committee (PMRC) and non-Promotional Materials Review Committee (nPMRC) for commercialized medical products.
• Provide clinical research regulatory and transactional legal advice, including supervision and mentoring of dedicated clinical research counsel.
• Provide pharmacy regulatory and transactional legal advice, including supervision and mentoring of dedicated pharmacy counsel.

 

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.


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