General Counsel

Description:

Scope:
The General Counsel is a business-oriented attorney with experience developing, implementing, and managing legal and compliance strategies in pharma/Medical Device companies with a drive to ensure that departmental results match regional goals and objectives.
Legal Responsibilities:

• Manage the in-house legal/compliance team to support the growing business
• Provide expertise in legal counsel matters such as but not limited to Marketing, Sales, Regulatory, Medical, Compliance, Clinical, and Human Resources.
• Manage the use of internal versus external legal counsel to minimize cost and risk
• Prepare, review and negotiate complex commercial agreements, 3rd party vendor agreements, service agreements, consulting agreements, corporate agreements, confidentiality agreements and IIT/Grant agreements.
• Support commercial organization in negotiating, development and maintaining contractual relationships. Identifying and communicating issues and risks for agreements.
• Support the commercial operations by providing substantive advice to the Sales, Marketing, Medical Affairs and Corporate teams concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, AdvaMed, Sunshine Act, Foreign Corrupt Practices Act and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement and interactions with healthcare professionals.
• Provide legal advice and assistance for the development of policies and training and conducting training of newly hired employees
• Manage patent and trademark portfolio and other intellectual property issues that may arise.
• Resolve routine and complex legal matters and manage them appropriately
• Communicate legal issues and risks to stakeholders regarding A Medical Device Company business
• Keep up to date on change in laws that impact medical device, human resources and other areas as needed
• Serve as a trusted resource to colleagues regarding legal, compliance, and other areas of subject matter expertise

Qualifications:

• JD Degree from an ABA accredited law school
• Admission to the Bar in Massachusetts or willing to be admitted to the Massachusetts Bar
• 9+ years of experience as an attorney/counsel, with at least 5 years supporting clients within the pharmaceutical, medical device or biotech industries.
• Demonstrated experience drafting and negotiating contracts for the Life Sciences industries.
• Exceptional written, verbal, and presentation communication skills, including strong contract drafting skills
• Ability to translate complex legal principles to management and other line function personnel
• Ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees
• Familiarity with FDA drug law, False Claims Act, Anti-Kickback Statute, OIG guidance, the AdvaMed Code, the Sunshine Act, Foreign Corrupt Practices Act, competition law and US medical devices compliance program requirements
• Ability to work collaboratively and effectively, as a team leader and a team member, with all internal and external partners and stakeholders

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