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General Counsel
Consulting
provided
exceptional
service in helping
my organization
recruit for a hard
to fill position.
They did extensive
work on the front
end to understand
our needs and
our culture and
began referring
highly qualified
candidates almost
immediately.

Melinda Burrows
Deputy General Counsel
- Litigation and
Compliance, Progress
Energy Service Company
LLC

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Counsel Jobs > Health Care/Counsel/In House/San Diego, California Job in California > Health Care/Counsel/In House/San Diego, California

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Health Care/Counsel/In House/San Diego, California

Refer job# PUGO6688

Counsel, Healthcare Regulatory Affairs (Wireless Health) The candidate provides General Legal counsel to all aspects of the company's Wireless Health organization regarding the development and execution of various programs, as well as otherwise conducting business Operations in conformance with applicable global healthcare laws, (i.e. HIPAA, HITECH, Stark, Health Reimbursement, Accountable Care Act, etc.) and regulations (i.e. FDA, CE, MHRA, etc.). Advises and consults with stakeholders and project managers, including providing education regarding proactive measures and approaches for executing strategies and tactics in compliance with global healthcare regulations. Updates the relevant organizational leaders on regulatory developments and communicates new developments to the affected business units. Facilitate the business objectives of the company by providing timely and effective Legal support to all the company's functions, as well as minimizing potential Legal exposure and risk. Will be responsible for rendering practical, timely, and high quality Legal counsel and guidance to all company's divisions and departments, including Regulatory, sales and Marketing, R&D, and Medical Affairs. Works closely with the Corporate Compliance Department to ensure compliance throughout the organization with regard to applicable global healthcare laws and regulations. One of the specific responsibilities is providing counsel on the development, Maintenance, and Distribution of materials used in connection with the sale and promotion of company's products and services. Will be responsible for ensuring that regulating body-approved prescribing information for company's products, global healthcare regulations, and other regulatory best practices are reflected in company's business activities. Work closely with company's business teams and regulatory affairs teams to develop creative Legal strategies, plans, templates and processes for new business and Commercial Models, working with the business to translate new Healthcare legislation and regulations into market leading business Models, and structuring, negotiating and closing of highly structured Commercial alliances with key strategic partners and customers to achieve key business objectives. Additional responsibilities will include: developing a framework for the business to meet evolving global regulatory requirements, the structuring of complex Distribution and sourcing agreements, advising on cutting edge Legal issues being raised by the use and adoption of company's products and services, advising the business on regulatory, privacy, antitrust and advertising/promotional matters, Supply Chain matters, assisting the business in structuring partner programs and defining Legal strategies and policy for novel Legal issues being raised by the use of company's products and services. A J.D. degree from a nationally accredited law school and admission to practice law as well as 10+ years experience as counsel on US drug/device Marketing and promotion will be required. Experience in developing global, Medical device and service strategy based on the relevant Legal regulatory environment and expertise in global healthcare advertising and promotional regulations required. Should have experience in reviewing and counseling on health care professional and consumer advertising and promotion strategies and tactics. Ability to analyze and interpret efficacy and Safety data required. Should have strong negotiation and decision-making skills. Should have advanced interpersonal and communication skills (written and verbal). Should have demonstrated counseling skills for interacting with stakeholders at all levels of the organization. Understanding of compliance and its importance in the Pharmaceutical and Medical device industries required. Experience in telemedicine, health, wireless health preferred. Should have significant in-house counsel, and global healthcare regulatory experience with excellent academic credentials. Candidates must have demonstrated experience in global healthcare Regulatory Law and also should have familiarity with health care compliance, rebates and discounts for Medical products, and government pricing.

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