Paralegal

PharmaEssentia U.S.A.•Burlington, MA

1d•Onsite

About The Position

PharmaEssentia USA Corporation is a rapidly growing biopharmaceutical innovator, leveraging deep expertise and scientific principles to deliver effective new biologics for challenging diseases in hematology and oncology. Founded in 2003, the company is expanding its global presence with operations in the U.S., Japan, and China. PharmaEssentia is seeking a highly organized, detail-oriented Paralegal to support the U.S. Legal & Compliance function in a dynamic, highly regulated biopharmaceutical environment. This role is based out of their U.S. commercial headquarters in Burlington, Massachusetts, and will engage with all levels of the U.S. organization as well as the HQ team in Taiwan. The Paralegal supports contracting, legal operations, compliance execution, and legal analysis for medical and commercial departments, enabling attorneys to focus on higher-risk and strategic matters. The position requires strong judgment, comfort with enterprise systems, and effective cross-functional partnership.

Requirements

Bachelor’s degree required.
Paralegal certificate from an ABA-approved or comparable program.
3+ years of experience as a paralegal with prior work in, or in direct support of, pharmaceutical, biotechnology, or medical device companies (required).
Demonstrated experience working in a highly regulated, FDA-governed environment.
Strong experience supporting contract reviews and negotiations.
Demonstrated ability to manage multiple matters in a fast-paced, evolving environment.
High degree of professionalism, discretion, and attention to detail.
Proficiency with Microsoft Office and CLM platforms.
Ability to work independently with appropriate judgment, escalation, and risk awareness.

Nice To Haves

Massachusetts area based candidate with ability to work hybrid from the Burlington, MA office.
Experience working with Ariba or similar enterprise procurement systems.
Familiarity with U.S. healthcare compliance frameworks relevant to FDA-regulated companies.
Experience supporting legal operations and training initiatives in a scaling organization.
Experience engaging AI to introduce efficiencies into

Responsibilities

Support drafting, review, execution, and administration of agreements (e.g., MSAs, SOWs, consulting, and vendor/service agreements).
Help improve efficiency, consistency, and cost control across legal intake, contracting, and approvals.
Support Legal & Compliance in advising Medical and Commercial teams on U.S. laws, regulations, policies, and processes for promotional, advertising, and HCP engagement activities (marketed and investigational products).
Perform initial reviews of Brand initiatives, materials, and HCP communications to spot legal/regulatory considerations and escalate as needed.
Support healthcare compliance execution (e.g., HCP interactions, transparency/disclosure obligations, and policy acknowledgments) through documentation and operational follow-through.
Manage competing priorities across contracting, compliance, and commercial support, adjusting to business needs.
Stay current on evolving legal, regulatory, and business considerations for a U.S. biopharmaceutical company.
Identify and flag routine issues for attorney review, including promotional/advertising, FDA/regulatory requirements, HCP interactions, and fraud/abuse risk.
Coordinate with global headquarters on contract and process alignment, as needed.
Support special projects and continuous improvement to increase efficiency, consistency, and appropriate in-sourcing of legal work.