General Counsel

Job 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.
PRIMARY RESPONSIBILITIES:
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 Sirtex 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