Provide day-to-day legal advice and risk assessments to in-market product teams.
Interpret and apply federal and state laws, such as the FDCA, FCA, Anti-Kickback Statute, and HIPAA/data privacy laws.
Advise on interactions with healthcare professionals, payers, patients, and patient advocacy organizations.
Review and approve promotional and non-promotional materials through the MLR review process.
Counsel on advertising, promotion, social media, and scientific exchange compliance.
Support field force initiatives, speaker programs, and patient engagement activities.
Draft, review, and negotiate a wide range of agreements, ensuring efficient contracting processes.
Monitor evolving healthcare laws, offering proactive guidance on emerging risks.
Develop and deliver training for business partners on legal and compliance issues.
May advise on payer engagement, government price reporting, and patient support services.
Requirements
Required Skills:
Juris Doctor (JD) degree and active bar membership in good standing (U.S. jurisdiction required).
Minimum 12 years of legal experience, including at least 7 years in the pharmaceutical or biotechnology industry or at a law firm focused on healthcare/life sciences.
Strong knowledge of the U.S. healthcare, pharmaceutical, and biotech regulatory environment (FDA, OIG, DOJ, FTC).
Demonstrated ability to balance legal risk with business objectives effectively.
Excellent communication, drafting, negotiation, and interpersonal skills.
Ability to work independently and collaboratively in a fast-paced, matrixed environment.
Preferred Skills:
Experience supporting commercial, medical affairs, and/or market access functions directly.
Federal and state data privacy laws expertise
Prior participation in medical regulatory and legal (promotional and non-promotional) committees.
Experience with digital health, social media, and emerging technologies in pharma.
Job Level: Management
Additional Information
The base compensation range for this role is: $261,000.00-$359,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offEquity / stock optionsPerformance bonusParental leave
Additional Information
About This Role:
Senior Commercial & Medical Counsel - US, you will be an integral member of our North America Legal team who provides strategic and solutions-oriented legal counsel to support our Commercial and Medical Affairs teams . You will be tasked with navigating a complex legal landscape, offering guidance on federal and state healthcare laws, regulations, and industry standards. Your role is vital in partnering with cross-functional business leaders to meet corporate objectives while managing legal risks. You will serve as a strategic business partner to cross-functional brand teams, delivering clear legal advice and practical, business-focused solutions. This position brings immense value to our organization by protecting our integrity and reputation, both in the US and globally, through keen legal acumen and problem-solving skills.
Biogen · Cambridge, MA