Commercial Counsel

PharmaEssentia U.S.A.; Burlington (MA); Hybrid; USD 157,080 - 239,700; Full time

Benefits offered by this job

Medical coverage

Dental and vision coverage

401(k) retirement plan

Job summary

PharmaEssentia USA is seeking a U.S.-focused Senior Legal Counsel to provide day-to-day legal guidance on the commercialization of prescription drugs, with cross-functional collaboration across marketing, regulatory, and compliance teams.

The role emphasizes risk-calibrated advice within a highly regulated biopharmaceutical environment and requires experience with HCP/HCO engagement, and promotional review processes.

Qualifications

• JD from an accredited law school and license to practice in at least one U.S. jurisdiction.
• 3+ years of legal experience advising life sciences companies, preferably in-house.
• Experience with branded pharmaceutical or medical device product commercialization.
• Knowledge of FDA advertising, healthcare compliance, and PhRMA Code.
• Ability to deliver clear, practical legal guidance to legal and non-legal stakeholders.
• Fluency in English.

Responsibilities

• Provide day-to-day legal advice on operation and commercialization of prescription drugs.
• Advise cross-functional teams on initiatives, identifying and mitigating legal risks.
• Draft, review, and negotiate commercial and healthcare-related agreements.
• Support healthcare compliance programs addressing promotion, HCP/HCO interactions, and transparency.
• Monitor regulatory developments and provide practical guidance.
• Develop and deliver legal training.
• Collaborate with global teams to manage high-volume legal and compliance workflows.

Skills

Legal advice

Regulatory compliance

Contract negotiation

Cross-functional collaboration

FDA advertising compliance

Risk assessment

English fluency

Education

Juris Doctor (JD)

Job description

Location: Burlington, MA (hybrid with 3 days per week in office)

The Company:

It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia USA. Join us, and let’s transform lives, together.

PharmaEssentia USA Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved in Europe and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.

Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchange (6446) and are expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung.

Position Overview

The person in this role will provide day-to-day, tactical, practical, and risk-calibrated legal advice and counseling to the U.S. business on a broad array of strategic and operational matters within a highly regulated commercial biopharmaceutical environment. This position will report to the Senior Counsel and will work closely with other Legal and Compliance team members to support business partners across the organization, including marketing and market research, U.S. sales and sales training, patient advocacy and patient support/patient services, regulatory, compliance, and other cross-functional stakeholders. The ideal candidate will be able to effectively manage a high volume of operational legal matters and have prior experience counseling prescription drug or medical device companies on legal issues relating to advertising and promotion, scientific exchange, patient support programs, HCP and HCO interactions, field and customer engagement, and healthcare compliance. This is a hybrid position in our Burlington, Massachusetts office, with the potential for some travel.

Key Responsibilities

• Provide day-to-day, practical, and risk-calibrated legal advice to business partners on matters related to the operation and commercialization of a branded pharmaceutical business, including advertising and promotion, social media and digital engagement, scientific exchange, patient support programs, HCP and HCO interactions, field and customer engagement, healthcare fraud and abuse, product labeling, pharmacovigilance, product liability, and other matters relevant to the development, manufacture, and commercialization of prescription drugs
• Advise Commercial, Patient Support, Regulatory, Compliance, and other cross-functional teams on business initiatives in a manner that advances company strategy while identifying, assessing, and mitigating legal and compliance risks
• Provide legal support for HCP and HCO engagement workflows and related documentation, including speaker programs and consulting arrangements
• Draft, review, and negotiate commercial and healthcare-related agreements in collaboration with internal stakeholders
• Collaborate with Compliance and cross-functional stakeholders to support healthcare compliance programs addressing drug promotion, field and customer engagement, HCP and HCO interactions, financial arrangements with healthcare providers, transparency reporting, monitoring, training, and related documentation requirement
• Monitor legal and regulatory developments relevant to the U.S. business and provide practical guidance on emerging risks
• Develop and deliver legal training
• Contribute to Legal and Compliance Department projects, process improvements, and strategic initiatives,
• Work independently and collaboratively with U.S. and global legal, compliance, and cross-functional colleagues to manage high-volume legal, contract, and compliance workflows with sound judgment, business pragmatism, ownership, and attention to detail

Required Qualifications

• JD from an accredited law school and admission to practice in at least one U.S. jurisdiction; Massachusetts admission preferred or ability to obtain in-house counsel status
• 3+ years of legal experience advising life sciences companies, preferably including in-house experience with a prescription drug or medical device company
• Experience advising life science companies on issues, risks, contracts, or litigation related to the commercialization of branded pharmaceutical or medical device products
• Working knowledge of laws, regulations, and industry guidance applicable to pharmaceutical commercialization, including FDA advertising and promotion requirements, healthcare fraud and abuse laws, the Anti-Kickback Statute, the False Claims Act, OIG guidance, transparency requirements, and the PhRMA Code
• Ability to communicate clear, practical, and risk-calibrated legal advice to legal and non-legal stakeholders in a fast-paced business environment
• Strong analytical and organizational skills
• Sound business judgment, attention to detail, and ability to operate effectively in a lean, collaborative, and high-performing environment
• Fluency in English

Preferred Qualifications

• Experience drafting, reviewing, and negotiating commercial and healthcare-related agreements
• Experience serving on or advising a promotional review committee, MLR committee, or similar cross-functional review process
• Familiarity with digital engagement, social media, market research, real-world evidence, artificial intelligence-enabled tools, or other emerging commercial and compliance issues
• Additional language skills, particularly Mandarin

The expected salary range for this position is $157,080-$239,700. Actual salary pay will be based on multiple factors, including geographic location, experience, qualifications, and other job-related factors permitted by law.

Benefits of working with our team:

PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:

• Comprehensive medical coverage
• Dental and vision coverage
• Generous paid time-off
• 401(k) retirement plan with competitive company match
• Medical & Dependent Care Flexible Spending Account
• Up to $150 monthly cell phone reimbursement
• Employee Assistance Program
• Free parking

EEO Statement

At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.

https://us.pharmaessentia.com/careers/