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General Counsel Consulting

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 > Corporate Counsel, Commercial & Compliance Job in California > Corporate Counsel, Commercial & Compliance

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Corporate Counsel, Commercial & Compliance

Refer job# YQUO151697

Corporate Counsel, Commercial & Compliance Duties: Provides legal and business advice and drafting expertise for a broad range of commercial and operational agreements, including non-disclosure, material transfer, supply, manufacturing, equipment, software, leases, distribution, clinical trial, pump training, and provider agreements with health insurance payors and administrators. Works closely with regulatory, sales and marketing groups to review patient and HCP-facing marketing and promotional materials for projects and events. Provides legal support for the Company's expanding international operations, proactively identify related business and legal risks, and collaborate cross-functionally to offer creative solutions to mitigate risks. Supports emergent commercial legal matters on an as-needed basis. Drafts, maintains, and revises compliance policies and procedures. Responds to compliance questions, concerns, and complaints from individuals throughout the organization, as well as external sources. Facilitates third party audits and conducts internal compliance audits to ensure global adherence to legal and compliance policies and procedures. Reviews requests for third party events, HCP arrangements, grants, charitable donations, and similar matters for compliance with laws and internal policies. Partners with business leaders to develop and obtain approval for the annual Needs Assessment, as well as ensure proposed engagements throughout the year fall within scope of identified legitimate business needs. Administers and audits compliance with HCP Interactions Policy, including review of all invoices from and proposed payments to HCPs. Assists attorneys with routine compliance investigations. Supports physician payment disclosure program administration on federal, state, and global levels. Identifies emerging industry and company trends to mitigate compliance risks through preparation and preemptive education. Prepares effective communications to various internal audiences to foster culture of compliance and messaging that succeeds to mitigate and eliminate the risk of healthcare fraud, waste, and abuse. Continuously improves compliance training and communications program. Consults as needed with peers in regulatory, finance, quality, and other departments to ensure compliance with laws and regulations impacting specific company functions. Identifies, recommends, and implements internal controls for appropriate approvals of new contractual commitments to further compliance program objectives. Functions independently and delivers results with minimum supervision. Maintains the confidentiality of Legal Department communications and documentation. Special projects as assigned. Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements. Qualifications: 3 plus years of relevant legal experience with complex commercial transactions, preferably including at least 1 year of in-house experience with a medical device, pharmaceutical or biotech company. In-depth understanding of the Federal False Claims Act, Anti-Kickback Statute, and Food Drug and Cosmetic Act. Working understanding of international, federal, and state rules and regulations applicable to medical device companies. Experience with and breadth of knowledge related to contract law. Working understanding of clinical trials and related laws, regulations, and agreements. Strong verbal and written communication skills. Ability to operate independently and prioritize effectively while handling substantial and diverse work volume and serving as a key contributor for a rapidly growing organization. High level of integrity supported by sound judgment and ethics. Familiarity with subject matter relevant for key areas of responsibilities. Effective interpersonal skills and presentation styles to interact with diverse audiences, including outside attorneys, senior management, and business associates. Expertise in counseling clients on best practices for commercial, compliance, clinical trial and supply chain functions. Experience negotiating and drafting supply agreements and vendor agreements for critical service providers. Law degree (JD or equivalent) and a license to practice in the state of California, or licensed in another state and registered as In-House Counsel in California.

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