MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1100 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.
The Assistant General Counsel will play a critical role in supporting the General Counsel in providing legal advice to support MCRA’s five business value creators- regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance along with supporting the development of new business and services. This position will be responsible for handling all complex legal matters and projects and providing expert advice on MCRA’s legal rights and duties.
Responsibilities and Duties
- Draft, review, lead and negotiate business agreements, transactions, consulting agreements, clinical trial agreements, supply agreements, NDA’s, MCA’s, referral agreements and license agreements.
- Manage outside counsel as necessary.
- In collaboration with the General Counsel, manage disputes, litigation, and employment matters.
- Apply business and legal judgment to proposed transactions, relationships, and other legal matters.
- Analyze and advise on complex legal issues arising out of MCRA’s global operations.
- Maintain a best practices corporate governance environment and protocol.
- Support the administration and maintenance of the company’s compliance program.
- Research and evaluate different risk factors regarding business decisions and operations.
- Provide advice, guidance, and support in connection with corporate transactions, in collaboration with business partners.
- Collaborate with the compliance department in development and implementation of appropriate policies and training programs to support global compliance with all applicable laws, regulations, and policies.
- Ensure all work products comply fully with SOPs, regulations, standards, policies, and the mission of MCRA.
- Collaborate with other MCRA business units on business development initiatives, including proposal development and bid defenses.
- Assist with additional projects as assigned.
Required Knowledge, Skills, and Experience
- 2-5 years of business/healthcare law experience at a law firm or corporate legal department is required.
- Experience with commercial/corporate agreements (consulting agreements, clinical trial agreements, supply agreements, NDA’s, MCA’s, referral agreements) is required.
- JD from an accredited law school, with requisite bar licensure in one or more U.S. jurisdictions.
- Knowledge of and experience in the medical device and/or pharmaceutical industry is required.
- Experience with FDA laws and regulations (e.g., AKS, FCPA), privacy, and compliance.
- Demonstrate the ability to manage multiple projects simultaneously in a fast-paced environment.
- Strong communication skills - both written and verbal.
- Must be a talented consensus builder and team player with the ability to engage and influence a multi-functional team.
- Must demonstrate experience identifying and resolving legal, compliance and regulatory issues quickly and effectively, with an ability to make real-time decisions.
- Demonstrated experience prioritizing conflicting demands from multiple business clients in an extremely entrepreneurial and fast-paced environment.
Compensation & Benefits
- Salary + bonus
- Medical, dental, and vision insurance
- Company-paid life insurance
- Company-paid STD and LTD
- 401(k) with company matching program
- Generous PTO policy
- Fully paid maternity leave benefits
- Parental leave
- Pre-tax public transit and parking benefit
$125,000 - $150,000 a year
NOTE:
This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
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