Contracts and Compliance Counsel

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/22/17
Mahwah, NJ
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/22/17

The Contracts Counsel is responsible for supporting the Legal & Compliance Department in drafting and reviewing contracts for various Getinge entities and resolving compliance related legal matters.

Responsibilities include:

  • Responsible for managing a substantial contract workload with consultants, hospitals, suppliers, contractors, distributors, service providers, software companies, etc.
  • Draft, review and negotiate purchase agreements, distribution agreements, supplier agreements, non-compete agreements, confidentiality agreements and consultant agreements.
  • Assist in the management of contract documentation flow, approvals and reporting consistent with internal processes.
  • Identify potential liability related to business practices, policies and compliance risk.
  • Conduct legal research and prepare memoranda.
  • Work with the Legal & Compliance Department to uncover and resolve compliance-related issues.
  • Assist in review and drafting of relevant legal and compliance policies.
  • Support the continuous improvement of standard form agreements and legal processes.
  • Performs other related duties and special projects as required.

Qualifications include:

  • This position requires an individual with strong analytical skills and the ability to work seamlessly in a matrix reporting structure
  • Must be detail oriented and have advanced skills in identifying legal and compliance issues
  • Must possess good judgment in knowing when and how to escalate issues to the appropriate level and propose solutions
  • Advanced skills in MS Office applications (Word, Excel, Outlook, PowerPoint) is required

Experience and Education Requirements:

  • Five years of legal experience, preferably at a law firm
  • Admitted to at least one state bar
  • Lawdegreefrom accredited legal program and member of the bar in at least one state

Quality Requirements:

  • Build Quality into all aspects of work.
  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to your job function).
  • You must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
  • Attend all required Quality & Compliance training at the specified interval.
  • Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
  • Must practice verbatim compliance (exact compliance, no interpretation) with corporate Quality and Regulatory procedures (As applicable to your job function).
  • If your job description requires customer facing activities, you must thoroughly understand and comply with the Customer complaint reporting process and complaint procedures (As applicable to your job function).
  • Must be able to promptly report any non-compliance issues to Chief QA, RA, Compliance officer or appropriate administrator, including the Compliance Hotline.
  • Must be competent with 21 CFR 820, 801, 803, 806 and any other applicable federal regulations, and Quality standards (As applicable to your job function).
  • Must not be debarred by FDA for work in any Medical Device or Pharmaceutical business.

Environmental/Safety Responsibilities:

  • Responsible for understanding and conforming with the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimized the effects on the environment.
  • Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.
  • Responsible for understanding and conforming with the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.
  • Duties are performed in an office environment.

Internal and External Contacts/Relationships:

  • Contact with vendors, consultants, customers, and distributors.
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