- 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
- 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
- Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
- A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
- Attractive compensation and benefit packages which are practical, robust and equitable.
- A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
- Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
- An unwavering commitment to company values, employee safety and excellence in everything we do.
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General Counsel - Woburn, United States - Sirtex
Description
Company Description
Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer.
More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries.
At Sirtex, we're transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do.We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients' lives by providing innovative interventional oncology solutions.
Here, you will be a vital contributor to our inspiring and bold mission.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:
Individual compensation for this job requisition will be based on non-discriminatory factors, including your geographic location, skills, experience, education and other factors as they relate to the position requirements.
Actual compensation may vary depending on the confirmed job-related skills and experience.
In addition to the expected base compensation, this role is eligible to participate in Sirtex's incentive programs (target bonus of 35% for this position) and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program.
All your information will be kept confidential according to EEO guidelines.
Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people's lives.
Sirtex offers qualified candidates:
Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments.
We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.
Sirtex is An Equal Opportunity/Affirmative Action Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law.
Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
