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In House Legal Job Listings
YOUR WINDOW TO A WORLD OF OPPORTUNITIES
 
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.
 
If you are an employer looking to hire an in-house counsel, please click here to contact us and submit your opening.
 
 

Texas - Associate Counsel - Managed Care

Dallas TX Associate Counsel - Managed Care
The candidate will support the managed care contracting efforts. Will provide legal advice and consultation to negotiators of hospital managed care contracts. Be responsive to local, regional and national contract negotiators on the managed care team. Advise the corporate managed care department and hospital operations on ideal contract language and statutory and regulatory requirements of managed care payors and entities.

The candidate should have an undergraduate and law degree from an ABA accredited law school with superior academic credentials. Should be licensed to practice law. Must have 3-7 years of managed care legal experience with knowledge of healthcare provider or plan issues. Should have a working knowledge of managed care or plan regulations including and associated statutes and regulations. Legal 3 - 7 Full-time 2013-01-25

Illinois - Enterprise Legal: Healthcare Transactional Attorney - Manager

Chicago IL Healthcare Transactional Attorney - Manager
The candidate will review, draft and negotiate a large number of medium to complex client transactions within a corporate environment. Will advise company leadership on legal risks associated with such transactions. Strategize with company executives prior to client negotiations. Stay abreast of and provide counsel on laws and regulations and risks governing consulting, technology and outsourcing services provided to health insurance clients and healthcare provider clients. Structure client transactions to be most advantageous from a legal and business perspective. Counsel, advise, and consult company executives based on accurate interpretation of contract documents and the facts of a business opportunity. Represent company's interests and interface directly with client counsel and negotiating teams. Educate company executives in regard to legal and risk management issues. Stay abreast of legal developments affecting the company, its clients, and industries and synthesize the information to incorporate it into company's transactional practices. Oversee, counsel, guide, train and support junior transactional attorneys. Develop internal guidelines, toolkits, and packaged knowledge on various legal and business issues. Develop subject matter expertise in one or more areas that benefit Legal and/or business. Support, promote and implement Legal Group initiatives. Stay abreast of and provide counsel on laws and regulations and risks governing consulting, technology and outsourcing services provided to health insurance clients and healthcare provider clients.

The candidate must have 3+ years of transactional experience in consulting, systems integration, and/or outsourcing areas in roles with increasing responsibility. Such experience should be in a law firm or in a fast-paced corporate legal/transaction group for a consulting, systems integration, and/or outsourcing services vendor. Should also have 1+ year of experience serving clients in the health market sector. Strong preference for direct experience at a health insurance company. Experience negotiating complex legal and business issues is preferred. Experience in Government procurement (State/Local, Federal/Provincial) is desired. Experience in independently managing and drafting transactional documents and correspondence is preferred. Understanding of Intellectual Property issues as they apply to consulting, systems integration, and outsourcing transactions is desired. Understanding of basic principles of Finance, Accounting, Marketing, and Management is preferred. Legal 3 - 5 Full-time 2013-01-24

Illinois - Nurse Attorney/Legal Nurse Consultant

Itasca IL Nurse Attorney / Legal Nurse Consultant
The candidate will provide claims adjusters and attorneys with detailed analysis of medical records and other pertinent medical information significant to allegations in liability claims. Will review, analyze, and summarize medical records and other pertinent documents. Research current literature on medical issues and maintain reference library for adjusters and attorneys. Provide informed opinion on medical issues relating to causality, accepted standards of care and prognosis of alleged injuries/illnesses. Prepare exhibits for deposition, trial or mediation including charts, tables, graphs, PowerPoint presentations. Assist with the location, selection and preparation of medical expert witnesses and consultants and develop and maintain a network of such experts. Assist in the development of questioning for cross examination of opposing medical experts. Provide individualized training and development to adjusters and/or attorneys. Attend roundtables, mediations, facilitations, settlement conferences, deposition and trials as requested. Participate in special projects as requested. Participate actively with various vendors and or business partners.

The candidate should have a Law degree or commensurate legal experience. Should be a registered nurse with 5+ years of clinical experience in acute or ambulatory healthcare setting. Advanced casualty claim knowledge is required. Knowledge of local and national healthcare information resources and medical experts is essential. Knowledge of legal terminology and civil procedure is a must. Legal 5 - 7 Full-time 2013-01-18

Massachusetts - Senior Counsel

Cambridge MA Senior Counsel
The candidate will prepare for new product launches and support regulatory, pricing and reimbursement initiatives. Will advise on legal issues relevant to commercialization of pharmaceutical products, including sales, marketing and distribution. Draft and participate in negotiations of a range of commercial contracts, including payer agreements, distribution agreements, rebate agreements and various marketing and market research agreements. Support paralegals with similar duties. Act as a business partner to the regulatory and compliance teams. Identify and advise on regulatory, product promotion, anti-corruption and privacy issues as necessary.

The candidate must have 8+ years of relevant experience as an attorney at a pharma/biotech. Should have broad corporate and commercial experience from the life sciences department of a leading law firm and/or an in-house corporate position with a multinational life sciences company. Must have extensive bio/pharma industry experience including compliance, sales promotion and marketing, regulatory and medical affairs, managed markets, government affairs, collaborations and interactions with health care providers. International travel will be required. Legal 8 - 10 Full-time 2013-01-09

North Carolina - Environmental Health and Safety ERP Implementation Manager

Charlotte NC Environmental Health and Safety ERP Implementation Manager
The candidate will work on assignment purely business and oriented towards processes, registration and consortium management. Will provide business-oriented, practical solutions for identified or potential environmental issues impacting clients. Provide technical direction on EH&S compliance, EH&S management system, and safety-related compliance projects. Develop EH&S compliance procedures, plans, permits, and reports. Design and implement EH&S management systems and programs including analysis of processes, organization and IT systems necessary for compliance. Reengineer EH&S and Life cycle process development and reporting. Responsible for data collection and use of IT systems integration for global blueprints roll-outs. Prepare documentation associated with technical analyses and research.

The candidate should have a Bachelor's degree. Degree in chemical engineering, bio-engineering or environmental science is desired. Legal experience or Law degree would be preferred. Must have 5+ years of Environment Health and Safety and Regulatory experience within a corporate environment. Should also have 3+ years of EH&S ERP Implementation experience. EH&S consulting experience is preferred. Experience in OSHA, REACh, CLP/GHS, and/or Environmental specific IT Tools is desired. Experience with change management and organizational impacts of EH&S and risk to organizations is preferred. Must be open to 80-100% travel. Legal 5 - 7 Full-time 2012-12-05

Michigan - Nurse Attorney / Legal Nurse Consultant ( PIP Liability )

Howell MI Nurse Attorney / Legal Nurse Consultant ( PIP Liability )
The candidate provides claims adjusters and attorneys with detailed analysis of medical records and other pertinent medical information significant to allegations in liability claims. Reviews, analyzes, and summarizes medical records and other pertinent documents. Researches current literature on medical issues and maintains reference library for adjusters and attorneys. Provides informed opinion on medical issues relating to causality, accepted standards of care and prognosis of alleged injuries/illnesses. Prepares exhibits for deposition, trial or mediation including charts, tables, graphs, power point presentations. Assists with the location, selection and preparation of medical expert witnesses and consultants and develops and maintains a network of such experts. Assists in the development of questioning for cross examination of opposing medical experts. Provides individualized training and development to adjusters and/or attorneys. Attends roundtables, mediations, facilitations, settlement conferences, deposition and trials as requested. Participates in special projects as requested. Participates actively with various vendors and or business partners. Deals with members and co-workers in a tactful, cooperative and helpful manner, reacts positively to suggestions or instructions from others. Understands the potential issues involved in change within the organization and can adjust to the changing work environment.

The candidate should have a Law degree or commensurate legal experience. Should be a Registered nurse with 5+ years of clinical experience in acute or ambulatory healthcare setting. Advanced casualty claim knowledge. Knowledge of local and national healthcare information resources and medical experts required. Knowledge of legal terminology and civil procedure needed. Should have a clear understanding of the scope of role responsibilities, possesses a high level of technical expertise commensurate with the business needs. Must have knowledge of technical materials, rules, procedures or facts required to effectively performing the role. Should be proficient using the Internet, MS Office, various vendor software products and have good typing ability. Legal 5 - 8 Full-time 2012-11-01

California - Senior Attorney

South San Francisco CA Senior Attorney
The candidate will provide advertising and promotion, regulatory, contracting, and general legal support to the company, specifically to the Commercial and Medical Affairs departments. Will serve as the legal business partner in support of the Commercial and Medical Affairs departments with oversight and guidance by the General Counsel. Report to the General Counsel and will interact daily with the Commercial, Medical Affairs and Regulatory Affairs departments, and may also interact with government agencies, law firms, trade organizations and other external agencies. Manage the company's healthcare compliance program, including the update, maintenance and consistent implementation of policies, and coordinate and/or provide training as needed. Participate in multidisciplinary committee reviews of advertising and promotion, grants and other payments to healthcare professionals, scientific and other materials as well as attend project team meetings as needed to provide legal feedback on commercial strategy. Coordinate with other members of the Legal department to provide comprehensive and consolidated legal responses to review committees and questions from internal departments and teams. Draft, review and negotiate product-related commercial agreements such as service agreements, consulting agreements and other agreements. Address potential healthcare/FDA compliance issues to prevent or minimize legal risk to the company. Work with internal stakeholders to achieve business goals within a compliance framework. Keep informed of new US healthcare laws, regulations, and industry trends affecting the company.

The candidate should have a J.D. degree with 8+ years of relevant industry and/or law firm experience. Graduation from an accredited law school is required. Admission to a State Bar and active license to practice law is needed. Experience at a pharmaceutical or biotechnology company supporting marketed products preferred. Specific expertise in FDA advertising and promotion regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required. Legal 8 - 10 Full-time 2012-10-30

California - Legal Counsel IV - FDA / Medical Device

Palo Alto CA Legal Counsel IV - FDA / Medical Device
The candidate will manage legal business matters pertaining to the organization. Will provide a variety of general corporate and commercial legal services to a number of in-house clients. Act as advisor on legal issues involving the organization's government and regulatory compliance. Review legal data and advises organization on appropriate legal action to be taken. Coordinate legal matters handled by outside counsel.

The candidate should have a J.D. degree from ABA accredited law school and Bar membership in one state in the United States. Must have 5-8 years of experience, preferably with 2-3 years of in-house experience. Experience of advising on and working knowledge of healthcare and medical device laws and regulations, including FDA, Anti-Kickback/Anti-Fraud compliance, STARK laws, HIPAA, advertising and promotional labeling, clinical trials (both investigator initiated and vendor initiated) and other similar laws and regulations applicable to therapeutic medical devices needed. General understanding of principles relating to medical device regulations of other countries would be an asset. General understanding of laws and regulations relating to patient/data privacy, anti-corruption, and anti-competition needed. Strong commercial transactions experience essential. Prior experience in a medical device company would be a big plus. Capability in other languages is also a big plus. Experience in general corporate matters, including corporate organization, securities compliance, drafting transactional documents, license agreements, employment law, immigration law, regulatory matters, risk management asset-backed financing, and contract management. Experience in trade secrets, advertising law, registration and other resolutions specific to the computer and technology industry as well as SEC reporting. Legal 5 - 8 Full-time 2012-10-04

New Jersey - Vice President, Global Regulatory Strategy

Madison NJ Vice President, Global Regulatory Strategy
The candidate will, under the general direction of the SVP Worldwide Safety and Regulatory (WSR), be responsible for providing leadership and support for all Consumer Healthcare regulatory activities worldwide. Will define innovative regulatory strategies for global new products and claims and be responsible for ensuring the integrity and timeliness of all global Regulatory submissions. Will also be responsible for all interactions with regional and local regulatory agencies. Lead global, regional and local regulatory affairs departments focused on effective commercial, development and manufacturing support and efficiencies. Develop and implement innovative Regulatory strategies for global, regional and local growth opportunities (e.g. new products and claims). Lead all company contacts with Global, Regional and Local Regulatory agencies and Board's of Health. Provide leadership, strategic and tactical Regulatory support for all Rx-OTC Switch programs. Provide guidance and interpretation of current and future regulations and regulatory legislation. Identify opportunities for exclusivity and differentiation for all new products and claims. Collaborate with all Consumer R&D functions in the development of new products and claims and the maintenance of existing products and claims. Collaborate with Global, Regional and Local Marketing in the development of new products and claims opportunities. Engage in all competitive claims challenges. Oversee the Advertising and Labeling Review processes. Collaborate within WSR to coordinate overlapping activities and present one voice to regulatory agencies. Lead and develop staff.

The candidate should have M.D. or Ph.D./PharmD in biological or chemical sciences OR a J.D. degree with strong scientific background. Must have 15 years of industry experience with 10+ years of experience in regulatory affairs. Should have significant industry experience in consumer healthcare (OTC's, Dietary Supplements). Must have proven record of addressing regulatory challenges linked to successful new product and claims strategies. Rx to OTC switch experience is required. Expert knowledge of global and local regulations and regulatory requirements is preferred. Understanding of OTC environment and complexity of products (i.e., drugs, dietary supplements, devices and cosmetics) is desired. Familiarity and positive relationships with major regulatory bodies (e.g., FDA, EMEA, etc.) is preferred. Legal 15 - 20 Full-time 2012-09-28

Kentucky - Legal Counsel

Louisville KY Legal Counsel
The candidate will provide legal advice and support for medicare advantage, medicare prescription drug program, and pharmacy business. Will negotiate and draft a variety of agreements in support of Medicare managed care, in compliance with CMS regulations, anti-kickback laws, false claims act, and other health care fraud and abuse laws. Counsel on regulatory compliance, business transactions, government relations, and corporate compliance. Manage client relationships.

The candidate should have a J.D. degree and excellent academic credentials from a ABA accredited law school. Active membership in a State Bar association is required. Must have 3-5 years of experience in health law, regulatory, and transactional experience with experience in Medicare at a law firm or in-house health care organization. Legal 3 - 5 Full-time 2012-09-21
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Texas - Associate Counsel - Managed Care
Refer job# TN4L25349
 
Associate Counsel - Managed Care
The candidate will support the managed care contracting efforts. Will provide legal advice and consultation to negotiators of hospital managed care contracts. Be responsive to local, regional and national contract negotiators on the managed care team. Advise the corporate managed care department and hospital operations on ideal contract language and statutory and regulatory requirements of managed care payors and entities.

The candidate should have an undergraduate and law degree from an ABA accredited law school with superior academic credentials. Should be licensed to practice law. Must have 3-7 years of managed care legal experience with knowledge of healthcare provider or plan issues. Should have a working knowledge of managed care or plan regulations including and associated statutes and regulations.
 
EMAIL TO COLLEAGUE  PERMALINK
 
Illinois - Enterprise Legal: Healthcare Transactional Attorney - Manager
Refer job# B8KN25343
 
Healthcare Transactional Attorney - Manager
The candidate will review, draft and negotiate a large number of medium to complex client transactions within a corporate environment. Will advise company leadership on legal risks associated with such transactions. Strategize with company executives prior to client negotiations. Stay abreast of and provide counsel on laws and regulations and risks governing consulting, technology and outsourcing services provided to health insurance clients and healthcare provider clients. Structure client transactions to be most advantageous from a legal and business perspective. Counsel, advise, and consult company executives based on accurate interpretation of contract documents and the facts of a business opportunity. Represent company's interests and interface directly with client counsel and negotiating teams. Educate company executives in regard to legal and risk management issues. Stay abreast of legal developments affecting the company, its clients, and industries and synthesize the information to incorporate it into company's transactional practices. Oversee, counsel, guide, train and support junior transactional attorneys. Develop internal guidelines, toolkits, and packaged knowledge on various legal and business issues. Develop subject matter expertise in one or more areas that benefit Legal and/or business. Support, promote and implement Legal Group initiatives. Stay abreast of and provide counsel on laws and regulations and risks governing consulting, technology and outsourcing services provided to health insurance clients and healthcare provider clients.

The candidate must have 3+ years of transactional experience in consulting, systems integration, and/or outsourcing areas in roles with increasing responsibility. Such experience should be in a law firm or in a fast-paced corporate legal/transaction group for a consulting, systems integration, and/or outsourcing services vendor. Should also have 1+ year of experience serving clients in the health market sector. Strong preference for direct experience at a health insurance company. Experience negotiating complex legal and business issues is preferred. Experience in Government procurement (State/Local, Federal/Provincial) is desired. Experience in independently managing and drafting transactional documents and correspondence is preferred. Understanding of Intellectual Property issues as they apply to consulting, systems integration, and outsourcing transactions is desired. Understanding of basic principles of Finance, Accounting, Marketing, and Management is preferred.
 
EMAIL TO COLLEAGUE  PERMALINK
 
Illinois - Nurse Attorney/Legal Nurse Consultant
Refer job# D4IJ25284
 
Nurse Attorney / Legal Nurse Consultant
The candidate will provide claims adjusters and attorneys with detailed analysis of medical records and other pertinent medical information significant to allegations in liability claims. Will review, analyze, and summarize medical records and other pertinent documents. Research current literature on medical issues and maintain reference library for adjusters and attorneys. Provide informed opinion on medical issues relating to causality, accepted standards of care and prognosis of alleged injuries/illnesses. Prepare exhibits for deposition, trial or mediation including charts, tables, graphs, PowerPoint presentations. Assist with the location, selection and preparation of medical expert witnesses and consultants and develop and maintain a network of such experts. Assist in the development of questioning for cross examination of opposing medical experts. Provide individualized training and development to adjusters and/or attorneys. Attend roundtables, mediations, facilitations, settlement conferences, deposition and trials as requested. Participate in special projects as requested. Participate actively with various vendors and or business partners.

The candidate should have a Law degree or commensurate legal experience. Should be a registered nurse with 5+ years of clinical experience in acute or ambulatory healthcare setting. Advanced casualty claim knowledge is required. Knowledge of local and national healthcare information resources and medical experts is essential. Knowledge of legal terminology and civil procedure is a must.
 
EMAIL TO COLLEAGUE  PERMALINK
 
 
Massachusetts - Senior Counsel
Refer job# 6EGV25159
 
Senior Counsel
The candidate will prepare for new product launches and support regulatory, pricing and reimbursement initiatives. Will advise on legal issues relevant to commercialization of pharmaceutical products, including sales, marketing and distribution. Draft and participate in negotiations of a range of commercial contracts, including payer agreements, distribution agreements, rebate agreements and various marketing and market research agreements. Support paralegals with similar duties. Act as a business partner to the regulatory and compliance teams. Identify and advise on regulatory, product promotion, anti-corruption and privacy issues as necessary.

The candidate must have 8+ years of relevant experience as an attorney at a pharma/biotech. Should have broad corporate and commercial experience from the life sciences department of a leading law firm and/or an in-house corporate position with a multinational life sciences company. Must have extensive bio/pharma industry experience including compliance, sales promotion and marketing, regulatory and medical affairs, managed markets, government affairs, collaborations and interactions with health care providers. International travel will be required.
 
EMAIL TO COLLEAGUE  PERMALINK
 
North Carolina - Environmental Health and Safety ERP Implementation Manager
Refer job# J9WZ24885
 
Environmental Health and Safety ERP Implementation Manager
The candidate will work on assignment purely business and oriented towards processes, registration and consortium management. Will provide business-oriented, practical solutions for identified or potential environmental issues impacting clients. Provide technical direction on EH&S compliance, EH&S management system, and safety-related compliance projects. Develop EH&S compliance procedures, plans, permits, and reports. Design and implement EH&S management systems and programs including analysis of processes, organization and IT systems necessary for compliance. Reengineer EH&S and Life cycle process development and reporting. Responsible for data collection and use of IT systems integration for global blueprints roll-outs. Prepare documentation associated with technical analyses and research.

The candidate should have a Bachelor's degree. Degree in chemical engineering, bio-engineering or environmental science is desired. Legal experience or Law degree would be preferred. Must have 5+ years of Environment Health and Safety and Regulatory experience within a corporate environment. Should also have 3+ years of EH&S ERP Implementation experience. EH&S consulting experience is preferred. Experience in OSHA, REACh, CLP/GHS, and/or Environmental specific IT Tools is desired. Experience with change management and organizational impacts of EH&S and risk to organizations is preferred. Must be open to 80-100% travel.
 
EMAIL TO COLLEAGUE  PERMALINK
 
Michigan - Nurse Attorney / Legal Nurse Consultant ( PIP Liability )
Refer job# 3N5O24541
 
Nurse Attorney / Legal Nurse Consultant ( PIP Liability )
The candidate provides claims adjusters and attorneys with detailed analysis of medical records and other pertinent medical information significant to allegations in liability claims. Reviews, analyzes, and summarizes medical records and other pertinent documents. Researches current literature on medical issues and maintains reference library for adjusters and attorneys. Provides informed opinion on medical issues relating to causality, accepted standards of care and prognosis of alleged injuries/illnesses. Prepares exhibits for deposition, trial or mediation including charts, tables, graphs, power point presentations. Assists with the location, selection and preparation of medical expert witnesses and consultants and develops and maintains a network of such experts. Assists in the development of questioning for cross examination of opposing medical experts. Provides individualized training and development to adjusters and/or attorneys. Attends roundtables, mediations, facilitations, settlement conferences, deposition and trials as requested. Participates in special projects as requested. Participates actively with various vendors and or business partners. Deals with members and co-workers in a tactful, cooperative and helpful manner, reacts positively to suggestions or instructions from others. Understands the potential issues involved in change within the organization and can adjust to the changing work environment.

The candidate should have a Law degree or commensurate legal experience. Should be a Registered nurse with 5+ years of clinical experience in acute or ambulatory healthcare setting. Advanced casualty claim knowledge. Knowledge of local and national healthcare information resources and medical experts required. Knowledge of legal terminology and civil procedure needed. Should have a clear understanding of the scope of role responsibilities, possesses a high level of technical expertise commensurate with the business needs. Must have knowledge of technical materials, rules, procedures or facts required to effectively performing the role. Should be proficient using the Internet, MS Office, various vendor software products and have good typing ability.
 
EMAIL TO COLLEAGUE  PERMALINK
 
 
California - Senior Attorney
Refer job# 83QL24495
 
Senior Attorney
The candidate will provide advertising and promotion, regulatory, contracting, and general legal support to the company, specifically to the Commercial and Medical Affairs departments. Will serve as the legal business partner in support of the Commercial and Medical Affairs departments with oversight and guidance by the General Counsel. Report to the General Counsel and will interact daily with the Commercial, Medical Affairs and Regulatory Affairs departments, and may also interact with government agencies, law firms, trade organizations and other external agencies. Manage the company's healthcare compliance program, including the update, maintenance and consistent implementation of policies, and coordinate and/or provide training as needed. Participate in multidisciplinary committee reviews of advertising and promotion, grants and other payments to healthcare professionals, scientific and other materials as well as attend project team meetings as needed to provide legal feedback on commercial strategy. Coordinate with other members of the Legal department to provide comprehensive and consolidated legal responses to review committees and questions from internal departments and teams. Draft, review and negotiate product-related commercial agreements such as service agreements, consulting agreements and other agreements. Address potential healthcare/FDA compliance issues to prevent or minimize legal risk to the company. Work with internal stakeholders to achieve business goals within a compliance framework. Keep informed of new US healthcare laws, regulations, and industry trends affecting the company.

The candidate should have a J.D. degree with 8+ years of relevant industry and/or law firm experience. Graduation from an accredited law school is required. Admission to a State Bar and active license to practice law is needed. Experience at a pharmaceutical or biotechnology company supporting marketed products preferred. Specific expertise in FDA advertising and promotion regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required.
 
EMAIL TO COLLEAGUE  PERMALINK
 
California - Legal Counsel IV - FDA / Medical Device
Refer job# LGR324040
 
Legal Counsel IV - FDA / Medical Device
The candidate will manage legal business matters pertaining to the organization. Will provide a variety of general corporate and commercial legal services to a number of in-house clients. Act as advisor on legal issues involving the organization's government and regulatory compliance. Review legal data and advises organization on appropriate legal action to be taken. Coordinate legal matters handled by outside counsel.

The candidate should have a J.D. degree from ABA accredited law school and Bar membership in one state in the United States. Must have 5-8 years of experience, preferably with 2-3 years of in-house experience. Experience of advising on and working knowledge of healthcare and medical device laws and regulations, including FDA, Anti-Kickback/Anti-Fraud compliance, STARK laws, HIPAA, advertising and promotional labeling, clinical trials (both investigator initiated and vendor initiated) and other similar laws and regulations applicable to therapeutic medical devices needed. General understanding of principles relating to medical device regulations of other countries would be an asset. General understanding of laws and regulations relating to patient/data privacy, anti-corruption, and anti-competition needed. Strong commercial transactions experience essential. Prior experience in a medical device company would be a big plus. Capability in other languages is also a big plus. Experience in general corporate matters, including corporate organization, securities compliance, drafting transactional documents, license agreements, employment law, immigration law, regulatory matters, risk management asset-backed financing, and contract management. Experience in trade secrets, advertising law, registration and other resolutions specific to the computer and technology industry as well as SEC reporting.
 
EMAIL TO COLLEAGUE  PERMALINK
 
New Jersey - Vice President, Global Regulatory Strategy
Refer job# EO2423870
 
Vice President, Global Regulatory Strategy
The candidate will, under the general direction of the SVP Worldwide Safety and Regulatory (WSR), be responsible for providing leadership and support for all Consumer Healthcare regulatory activities worldwide. Will define innovative regulatory strategies for global new products and claims and be responsible for ensuring the integrity and timeliness of all global Regulatory submissions. Will also be responsible for all interactions with regional and local regulatory agencies. Lead global, regional and local regulatory affairs departments focused on effective commercial, development and manufacturing support and efficiencies. Develop and implement innovative Regulatory strategies for global, regional and local growth opportunities (e.g. new products and claims). Lead all company contacts with Global, Regional and Local Regulatory agencies and Board's of Health. Provide leadership, strategic and tactical Regulatory support for all Rx-OTC Switch programs. Provide guidance and interpretation of current and future regulations and regulatory legislation. Identify opportunities for exclusivity and differentiation for all new products and claims. Collaborate with all Consumer R&D functions in the development of new products and claims and the maintenance of existing products and claims. Collaborate with Global, Regional and Local Marketing in the development of new products and claims opportunities. Engage in all competitive claims challenges. Oversee the Advertising and Labeling Review processes. Collaborate within WSR to coordinate overlapping activities and present one voice to regulatory agencies. Lead and develop staff.

The candidate should have M.D. or Ph.D./PharmD in biological or chemical sciences OR a J.D. degree with strong scientific background. Must have 15 years of industry experience with 10+ years of experience in regulatory affairs. Should have significant industry experience in consumer healthcare (OTC's, Dietary Supplements). Must have proven record of addressing regulatory challenges linked to successful new product and claims strategies. Rx to OTC switch experience is required. Expert knowledge of global and local regulations and regulatory requirements is preferred. Understanding of OTC environment and complexity of products (i.e., drugs, dietary supplements, devices and cosmetics) is desired. Familiarity and positive relationships with major regulatory bodies (e.g., FDA, EMEA, etc.) is preferred.
 
EMAIL TO COLLEAGUE  PERMALINK
 
 
Kentucky - Legal Counsel
Refer job# 3NB423689
 
Legal Counsel
The candidate will provide legal advice and support for medicare advantage, medicare prescription drug program, and pharmacy business. Will negotiate and draft a variety of agreements in support of Medicare managed care, in compliance with CMS regulations, anti-kickback laws, false claims act, and other health care fraud and abuse laws. Counsel on regulatory compliance, business transactions, government relations, and corporate compliance. Manage client relationships.

The candidate should have a J.D. degree and excellent academic credentials from a ABA accredited law school. Active membership in a State Bar association is required. Must have 3-5 years of experience in health law, regulatory, and transactional experience with experience in Medicare at a law firm or in-house health care organization.
 
EMAIL TO COLLEAGUE  PERMALINK
 

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