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In House Legal Job Listings

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Welcome to the job listings section of General Counsel Consulting. We are constantly updating our jobs seven days a week. As a firm dedicated to in-house search and placement, our ability to forge strong relationships with top-rated companies around the world allows us to offer our candidates a breadth of opportunities we believe is unrivaled.
 
We are pleased that your assessment of options has led you to General Counsel Consulting, and we invite you to browse our website to learn more about our firm and the career opportunities we offer. If you would like to be considered for an in-house attorney position, feel free to submit your resume.
 
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Neuromuscular Franchise Counsel

Boston MA Neuromuscular Franchise Counsel The candidate will be responsible for providing this cross-functional franchise with legal, regulatory and healthcare compliance counsel and handling a variety of business transactions and contracting. This position will act as counsel for all neuromuscular products and will provide substantive advice to cross-functional departments including Commercial, Medical Affairs, and Regulatory Affairs and will support research and development activities in the US. Will provide counsel concerning a broad range of legal, regulatory and compliance issues, including, among other things, application and interpretation of FDA regulations, the False Claims Act, Anti-Kickback Statute and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals. Provides strategic, operational and tactical legal and business insight on the commercial launch of product candidates in the US, From a legal and regulatory perspective, review and advise on programs, initiatives, contracts, policies and training related to sales, marketing, reimbursement, market access, case management, non-promotional education and scientific exchange, From a legal and regulatory perspective, review and advise on promotional materials, sales training materials, federal and state government price reports, product and disease-related communications and health economics materials; serve as a member of Materials Review Committee, along with medical and regulatory colleagues, From a legal and regulatory perspective, review and advise on interactions with patients, healthcare professionals, institutions, payors, regulatory agencies and government reimbursement programs. Serve as subject matter expert in the areas of US healthcare law and all applicable pharmaceutical marketing, drug pricing and reimbursement, anti-kickback, privacy, fraud and abuse, anti-bribery, Sunshine Act and product liability statutes and regulations, Identify training needs within the organization; develop and present training sessions on relevant laws and legal/business issues. Stay abreast of and communicate to the organization all significant pending and actual decisions, legislation and regulatory rulings that may affect the company in the area of commercial healthcare law, Closely coordinate risk assessment, investigation, training and update activities with Compliance personnel. Knowledge of and proficiency with laws and regulations applicable to global pharmaceutical companies, including among other things, the US Foreign Corrupt Practices Act, US fraud and abuse and false claims laws and PhRMA Code on Interactions with Healthcare Professionals.

The candidate should have JD from a law school accredited by the American Bar Association (ABA). Should be admitted to practice law in one or more states. Should have 7 years of biopharmaceutical industry experience, with extensive experience within a commercial stage pharmaceutical or biotech company, or law firm equivalent, Large law firm experience helpful. Experience with launching new products and/or new indications is essential. Expertise in the areas of corporate commercial healthcare and FDA regulatory law and regulation, including with respect to FDA labeling and promotional matters, healthcare fraud and abuse laws, pricing and reimbursement issues, US transparency laws and regulations, privacy laws, anti-bribery laws, and other laws and regulations related to the development and commercialization of pharmaceutical products.
Legal 7 - 0 Full-time 2019-12-09
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1
 
Neuromuscular Franchise Counsel
Refer job# PKTU147482
 
Neuromuscular Franchise Counsel The candidate will be responsible for providing this cross-functional franchise with legal, regulatory and healthcare compliance counsel and handling a variety of business transactions and contracting. This position will act as counsel for all neuromuscular products and will provide substantive advice to cross-functional departments including Commercial, Medical Affairs, and Regulatory Affairs and will support research and development activities in the US. Will provide counsel concerning a broad range of legal, regulatory and compliance issues, including, among other things, application and interpretation of FDA regulations, the False Claims Act, Anti-Kickback Statute and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals. Provides strategic, operational and tactical legal and business insight on the commercial launch of product candidates in the US, From a legal and regulatory perspective, review and advise on programs, initiatives, contracts, policies and training related to sales, marketing, reimbursement, market access, case management, non-promotional education and scientific exchange, From a legal and regulatory perspective, review and advise on promotional materials, sales training materials, federal and state government price reports, product and disease-related communications and health economics materials; serve as a member of Materials Review Committee, along with medical and regulatory colleagues, From a legal and regulatory perspective, review and advise on interactions with patients, healthcare professionals, institutions, payors, regulatory agencies and government reimbursement programs. Serve as subject matter expert in the areas of US healthcare law and all applicable pharmaceutical marketing, drug pricing and reimbursement, anti-kickback, privacy, fraud and abuse, anti-bribery, Sunshine Act and product liability statutes and regulations, Identify training needs within the organization; develop and present training sessions on relevant laws and legal/business issues. Stay abreast of and communicate to the organization all significant pending and actual decisions, legislation and regulatory rulings that may affect the company in the area of commercial healthcare law, Closely coordinate risk assessment, investigation, training and update activities with Compliance personnel. Knowledge of and proficiency with laws and regulations applicable to global pharmaceutical companies, including among other things, the US Foreign Corrupt Practices Act, US fraud and abuse and false claims laws and PhRMA Code on Interactions with Healthcare Professionals.

The candidate should have JD from a law school accredited by the American Bar Association (ABA). Should be admitted to practice law in one or more states. Should have 7 years of biopharmaceutical industry experience, with extensive experience within a commercial stage pharmaceutical or biotech company, or law firm equivalent, Large law firm experience helpful. Experience with launching new products and/or new indications is essential. Expertise in the areas of corporate commercial healthcare and FDA regulatory law and regulation, including with respect to FDA labeling and promotional matters, healthcare fraud and abuse laws, pricing and reimbursement issues, US transparency laws and regulations, privacy laws, anti-bribery laws, and other laws and regulations related to the development and commercialization of pharmaceutical products.
 
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