Sr. Director, Healthcare Law at Jobot
San Francisco, CA 94104
About the Job
This Jobot Job is hosted by: Andrew Castillo
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $225,000 - $329,000 per year
A bit about us:
Our Client is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases.
Why join us?
Hybrid work schedule
Casual environment
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Job Details
THE OPPORTUNITY
We are seeking a dynamic and experienced Healthcare Law Attorney with compliance and privacy experience to complement our growing Legal Department as we further our mission of addressing unmet need in infectious diseases and other serious conditions, including viral-associated diseases. Reporting to our EVP, General Counsel & Corporate Secretary, this attorney will provide and oversee the development, execution, analysis, interpretation and communication of healthcare law aspects.
This role is located in San Francisco at our corporate office and there is a requirement to be onsite at least three days per week.
WHAT YOU'LL DO
Serve as lead counsel for healthcare law issues related to our product candidates, including review of all external communications, participation in cross-functional committees charged with setting/implementing clinical and commercial development as well as reviewing scientific, clinical, and medical publications.
Provide advice on legal business matters pertaining to clinical and commercial law as well as on privacy and governmental matters, including FOIA requests.
Provide current and consistent legal advice related to laws, regulations and industry trends affecting the biopharmaceutical sector, including, for example, healthcare laws, trade compliance guidance documents and regulations, healthcare regulatory issues, healthcare fraud and abuse, pharmacovigilance, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to investigational and commercial therapeutic products.
Work with the General Counsel in supporting our internal teams by providing critical legal advice and guidance related to healthcare compliance including those related to, e.g., FDCA and related FDA Guidance documents, U.S. PhRMA Code, the Sunshine Act, HIPAA, Stark Law, Anti-Kickback Statute, False Claims Act, Conflicts of Interest, GDPR and similar requirements globally.
Support the transactional group by providing regulatory and compliance guidance with respect to clinical trial agreements, consulting agreements, speaker agreements, purchase and distribution agreements, supply agreements, advisory board agreements, certain vendor services agreements, and other related agreements.
Provide compliance guidance related to contracting with HCPs, including conducting FMV analysis and transparency reporting with respect to the Company's external advisory boards.
Support clinical operations by providing review of Informed Consent Forms (ICFs), management of adverse events/patient injury issues, and handling of site specific issues/study promotions.
Understand the strategic and tactical objectives of the business and develop creative and thoughtful solutions considering the current legal and regulatory landscape, policies and procedures and the current and future needs of the organization.
Exhibit superior legal skills together with a proficiency for critical thinking and problem solving in a multi-functional environment.
Manage the drafting, review and negotiation of clinical related contracts and agreements.
Work with the Clinical Operations team, Legal team and external partners to ensure clinical agreements comply with business best practices and relevant country regulations.
Draft and negotiate other commercial and complex transactions as assigned.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $225,000 - $329,000 per year
A bit about us:
Our Client is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases.
Why join us?
Hybrid work schedule
Casual environment
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Job Details
THE OPPORTUNITY
We are seeking a dynamic and experienced Healthcare Law Attorney with compliance and privacy experience to complement our growing Legal Department as we further our mission of addressing unmet need in infectious diseases and other serious conditions, including viral-associated diseases. Reporting to our EVP, General Counsel & Corporate Secretary, this attorney will provide and oversee the development, execution, analysis, interpretation and communication of healthcare law aspects.
This role is located in San Francisco at our corporate office and there is a requirement to be onsite at least three days per week.
WHAT YOU'LL DO
Serve as lead counsel for healthcare law issues related to our product candidates, including review of all external communications, participation in cross-functional committees charged with setting/implementing clinical and commercial development as well as reviewing scientific, clinical, and medical publications.
Provide advice on legal business matters pertaining to clinical and commercial law as well as on privacy and governmental matters, including FOIA requests.
Provide current and consistent legal advice related to laws, regulations and industry trends affecting the biopharmaceutical sector, including, for example, healthcare laws, trade compliance guidance documents and regulations, healthcare regulatory issues, healthcare fraud and abuse, pharmacovigilance, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to investigational and commercial therapeutic products.
Work with the General Counsel in supporting our internal teams by providing critical legal advice and guidance related to healthcare compliance including those related to, e.g., FDCA and related FDA Guidance documents, U.S. PhRMA Code, the Sunshine Act, HIPAA, Stark Law, Anti-Kickback Statute, False Claims Act, Conflicts of Interest, GDPR and similar requirements globally.
Support the transactional group by providing regulatory and compliance guidance with respect to clinical trial agreements, consulting agreements, speaker agreements, purchase and distribution agreements, supply agreements, advisory board agreements, certain vendor services agreements, and other related agreements.
Provide compliance guidance related to contracting with HCPs, including conducting FMV analysis and transparency reporting with respect to the Company's external advisory boards.
Support clinical operations by providing review of Informed Consent Forms (ICFs), management of adverse events/patient injury issues, and handling of site specific issues/study promotions.
Understand the strategic and tactical objectives of the business and develop creative and thoughtful solutions considering the current legal and regulatory landscape, policies and procedures and the current and future needs of the organization.
Exhibit superior legal skills together with a proficiency for critical thinking and problem solving in a multi-functional environment.
Manage the drafting, review and negotiation of clinical related contracts and agreements.
Work with the Clinical Operations team, Legal team and external partners to ensure clinical agreements comply with business best practices and relevant country regulations.
Draft and negotiate other commercial and complex transactions as assigned.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
225,000 - 329,000 /year