Commercial Counsel

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 Pharma Essentia USA. Join us, and let’s transform lives, together.

Pharma Essentia 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.

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.

• 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…