Senior Regulatory Counsel
The candidate will provide legal advice, counsel, and services to ensure that the organization is operating in compliance with applicable laws and regulations, investigate and resolve matters, and respond to questions from regulatory authorities. Will also advise on product promotion and advertising materials and labeling. Provides counsel to the company on regulatory matters, with particular emphasis on the Food, Drug and Cosmetic Act, FDA regul... read more
Food Law Counsel
The candidate will advice the business on product regulatory issues/requirements while handling a complete range of food law issues, including: Ingredient approvals for food and color additives. Will product claims, such as health claims, nutrient content claims and structure-function claims. Food safety issues related to FSMA as well as the general adulteration and misbranding provisions of the Federal Food, Drug and Cosmetic Act. Participate as the Law D... read more
Responsibilities: Provide ongoing advice and support principally related to commercial, supplier and sourcing contracts, proposals, SOWs, etc. including the drafting, review, and negotiation of contracts. Provide leadership and legal advice on a range of legal, regulatory and compliance matters, including, pharmaceutical clinical or commercial regulatory, transportation compliance, commercial antitrust, anti-bribery/FCPA, products liability, and data priv...
Counsel, Clinical Operations
Responsibilities: Negotiates and drafts contracts related to clinical trials, including Company-sponsored clinical trial agreements, CRO agreements, IST agreements, and vendor agreements. Negotiates and drafts HCP agreements. Reviews informed consent forms and authorizations. Provides legal interpretation on clinical agreements, vendor agreements, informed consents and authorizations and other related business matters. Interfaces with external ...
Senior Director, Executive Counsel
Duties: Provide timely and competent legal services in support of Commercialsâ€™ Respiratory business unit and other projects/duties as assigned. Ensure client operations comply with applicable laws, regulations and company policies, including the Anti-Kickback Statue and other US healthcare compliance laws and regulations, antitrust and FDA requirements . Analyze product promotional materials and initiatives, advisory board proposal...
Junior In-House Attorney
Responsibilities: Prepare, analyze and review a variety of commercial contracts with vendors, customers and other third parties (examples include, NDAs, Supply Agreements, MSAs, Consulting Agreements, Software License Agreements, POs., Lease Agreements, etc.); Draft, develop and update contract templates and other forms used by the organization; Negotiate commercial contracts, alongside business personnel, under swift time constraints while meeting...
IRB Regulatory Board Chair
Responsibilities: Chair Board meetings to ensure compliance with federal and state laws and Company policies and procedures. Provide ethical and legal support and advice to Board members Facilitate discussion from Board Members. Assist in resolution of disagreements between Board members. Analyze and present protocols and other agenda items at Board meetings to facilitate informed decision making, and to set standards and role model effective pre...
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Executive Director & Assistant General Counsel, Commercial
Duties: Serve as the lead attorney and strategic advisor for a wide range of regulatory matters including: Fraud and Abuse, Stark/Anti-Kickback issues, FDA marketing (advertising, promotion, labelling) and other FDA regulatory including clinical R & D issues, impact of proposed legislation and reporting requirements (state and federal), and other regulatory matters. Advise and consult with all levels of the organiz...
Associate Director, Compliance Counsel, Global Compliance & Ethics
Responsibilities: Brand lawyer supporting marketed and/or pipeline products: Counsel internal brand teams regarding advertising and promotion, sales and marketing initiatives, compliance rules and regulations, FDA and OIG guidance documents, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations...
Associate Director, US Commercial Counsel
Responsibilities: Provide strategic legal guidance to senior business leaders in connection with fraud and abuse issues, advertising and promotion matters, commercial and medical affairs strategies, sales training and compensation, advisory boards, speakers bureau and other HCP engagements, communications with FDA and other matters relevant to the commercialization of biotech and orphan drug products. Guide and counsel key stakehol...
Manager, Clinical Counsel
Duties: Will be an integral member of the group that is charged with the timely and thorough review, negotiation and management of Clinical templates and routine third party contracts including clinical trial agreements and informed consent forms supporting clinical research. Reporting to the Vice-President, Associate General Counsel, the successful candidate will: (i) review and negotiate clinical trial related contracts for multiple clinical tri...
Senior Counsel - R&D Law
Duties: Direct client responsibility in support of a broad range of company R&D, Medical and early commercialization related activities in support of one or more therapeutic areas, along with general responsibilities in support of these business units. Will be responsible for advising clients on a broad array of issues relating to pharmaceutical regulations, product development, clinical trials, product labeling, anti-kickback and anti-bribery laws...