General Counsel

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.

As a member of the Senior LeadershipTeam, the General Counsel is responsible for setting the direction and leading all legal, compliance and collaborating with the Sirtex QA/RA team to address regulatory matters on behalf of the organization.

This role will report to CEO

RESPONSIBILITIES / AUTHORITIES:
Establish an in-house legal/compliance presence 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 commerical agreements, 3rd party vendor agreements, service agreements, consulting agreements, corporate agreements, confidentiality agreements and IIT/Grant agreements.
Support commerical organization in negotiating, development and maintaining contractual relationships. Identifying and communicating issues and risks for agreements.
Support Sir-Spheres product and future products by providing substative 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 competetion law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement and interacations with healthcare professionals.
Provide legal advice and assistance for the development of policies and training and conducting training of newly hired employees
Resolve routine and complex legal matters and manage them appropriately
Communicate legal issues and risks to interal and external stakeholders regarding Sirtex's business
Keep up to date on change in laws that impact medical device, human resources and other areas as needed
Represent Sirtex externally to customers, suppliers, competitors or government agencies such as the FDA as needed
Serve as a trusted resource to colleagues regarding legal, compliance, and other areas of subject matter expertise
Undergo all formal Training Events as may be Directed from time-to-time
Observe and Comply with all Sirtex Corporate Policies
Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.
Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions and other requirements.
EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS:
JD Degree from an ABA accredited law school
Admission to the Bar in Massachusetts or willing to be admitted to the Massachusetts Bar
7+ years of experience as an attorney/counsel, with at least 2 years in a Law firm 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 and biologic law, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, Foreign Corrupt Practices Act, competition law and US medical devices compliance program requirements
 

WHAT YOU CAN EXPECT FROM SIRTEX:
If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:

Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
A working culture of respect, diversity and performance to help facilitate an inclusive culture
Attractive compensation and benefit packages which are practical, robust, fair and equitable
A place to grow through career development and training opportunities
Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world
HOW TO APPLY:
To apply, please email your cover letter and resume to Human Resources by clicking Apply to this Job.