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JDHuntr In-House Counsel Jobs
San Mateo, CA, United States
Experienced ERISA Counsel - Remote Opportunity - San Mateo, CA Are you an experienced attorney with a specialization in ERISA compliance? We are currently seeking a highly skilled ERISA Counsel to join our legal team. In this role, you will have the opportunity to provide prompt, practical compliance advice and support to our business, ensuring ad
Job Source: JDHuntr In-House Counsel JobsParadigm
San Francisco, CA, United States
Paradigm is a San Francisco-based crypto/web3 investment firm with approximately $8 billion in assets under management across multiple funds. We were co-founded in 2018 by Matt Huang (former Partner at Sequoia Capital) and Fred Ehrsam (co-founder of Coinbase). Paradigm makes investments in crypto-related companies and protocols agnostic to the stag
Job Source: ParadigmCoherus BioSciences
Redwood City, CA, United States
Title: Director, Compliance Reports To: Head of Quality Location: Redwood City, California Classification: Exempt Overview: Principle Responsibilities and Duties: This position is responsible for establishing and implementing global compliance systems for operations within the Coherus manufacturing operations network. GxP Compliance is accountabl
Job Source: Coherus BioSciencesMayfair Finance, Inc.
San Mateo, CA, United States
Mayfair is hiring a Director of Compliance to help us ensure security and confidentiality in our operations. You'll help guarantee compliance with all relevant legal requirements as we expand into new countries and partner with a variety of platforms to bring value to customers. The ideal candidate is precise, analytical, and detail-obsessed when i
Job Source: Mayfair Finance, Inc.Paradigm
San Francisco, CA, United States
Paradigm is a San Francisco-based crypto/web3 investment firm with approximately $8 billion in assets under management across multiple funds. We were co-founded in 2018 by Matt Huang (former Partner at Sequoia Capital) and Fred Ehrsam (co-founder of Coinbase). Paradigm makes investments in crypto-related companies and protocols agnostic to the stag
Job Source: ParadigmCoherus BioSciences
Redwood City, CA, United States
Title: Director, Compliance Reports To: Head of Quality Location: Redwood City, California Classification: Exempt Overview: Principle Responsibilities and Duties: This position is responsible for establishing and implementing global compliance systems for operations within the Coherus manufacturing operations network. GxP Compliance is accountabl
Job Source: Coherus BioSciencesCruise
San Francisco, CA, United States
We're Cruise, a self-driving service designed for the cities we love. We’re building the world’s most advanced self-driving vehicles to safely connect people to the places, things, and experiences they care about. We believe self-driving vehicles will help save lives, reshape cities, give back time in transit, and restore freedom of movement for m
Job Source: CruiseCruise Automation
San Francisco, CA, United States
Cruise is creating a new-to-the-world service and a world-changing category of autonomous vehicle mobility. On the legal side, the rules are being written now, and we're the team charged with helping guide the company on legal and risk considerations as we unlock the future. We're a collegial group in which every role matters, and you'll have an im
Job Source: Cruise AutomationSouth San Francisco, CA, United States
We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the healthspan of people with cardiovascular and neuromuscular diseases of impaired muscle function.
We are seeking a Compliance Counsel to join our Compliance group. This position will have the opportunity to provide compliance and business conduct advice and support across the company, although based on experience and prior job responsibilities, this role will also have primary responsibility for defined functional areas. This position will report to the VP, Chief Compliance Officer.
Responsibilities
Serve as a key subject matter expert in supporting the business conduct and compliance advisory needs of the Commercial organization.
Expert understanding of the laws, regulations, industry standards, and guidelines for interactions with healthcare professionals and other Ethical codes and regulations.
Advise and counsel on appropriate business conduct interactions with healthcare providers, patients, managed care entities, academic institutions, and government entities, including on topics such as fair market value, advisory board participation, sales and marketing, .
Enhance and implement systems or capture mechanisms for all business conduct and compliance advisory guidance for company posterity (e.g, electronic resource directory).
Oversee and manage the process and capture of timely, accurate and consistent data for incorporation into filings and reports related to required HCP payment disclosure, including U.S. Sunshine Act and state law reporting.
Partner with all Company internal clients to clarify and help validate data, and prepare reports and filings for transparency data for final attestation by the Chief Compliance Officer.
Oversee, manage, and engage in continuous improvement, review, drafting, and project management for all Compliance-specific policies, SOPs, guidelines, and work instructions.
Serve as an accountability partner for managing, maintaining, documenting, and dispatch of all Compliance-training materials, policies, or content (including New Hire Compliance Trainings) and other LMS project management areas.
Oversee and manage the process, data capture, analytics, and report generation for compliance monitoring activities (live monitoring and process/documentation monitoring) in conjunction with the Chief Compliance Officer.
Serve as principal Compliance reviewer for the Corporate Affairs Grants Review Committee (GRC).
Serve as primary reviewer for key compliance and risk identification expertise in both the Promotional Materials Review Committee (PMRC) and the Medical Review Committee (MRC).
Assist and partner with the Chief Compliance Officer on various privacy-related projects and policies, and Privacy project management areas, including the Privacy Council and affiliated workgroups, as applicable (e.g, Artificial Intelligence or Cybersecurity)
Partner and collaborate, as appropriate and applicable, with Legal colleagues on matters that pertain to overlap of compliance and Legal (e.g., Privacy documentation reviews)
Keep apprised of applicable federal, state, and local laws and regulations and apply them to areas of responsibility.
Experience with drug advertising and pharmaceutical drug promotion practices, and privacy (CCPA and GDPR) helpful.
Qualifications
JD degree with a minimum of 5-10 years of experience as in-house counsel or associate at a major law firm with a background in biotechnology, pharma or healthcare related matters. A combination of both in-house and law firm experience is a plus. However, expertise in healthcare law compliance is a requirement.
Admitted to at least one state bar. Admitted to California bar or admitted as Registered In-House Counsel required.
Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility.
Solution-oriented and growth mindset in working with clients on matters of business advisory, compliance, and ethics in the many emerging and novel areas of pharmaceutical/life science.
Excellent communication skills, both oral and written.
Well-organized and hardworking, with the ability to manage numerous projects simultaneously under deadline pressure.
Excellent analytical skills, with a strong ability to draft and review legal documents, analyze legal advice and apply legal advice to business needs.
Ability to form strong working relationships with all levels of management, employees, and partners while maintaining firm adherence to proper legal standards.
Team-oriented, sound judgment, self-motivation and willingness to take initiative.
Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
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Email Alert for Director, Compliance Counsel (Healthcare Law Compliance) jobs in South San Francisco, CA, United States
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