Gilead Sciences, Inc.
Associate Director, Ethics & Compliance Advisor, US Medical Affairs
Gilead Sciences, Inc., Foster City, California, United States, 94420
Associate Director, Ethics & Compliance Advisor, US Medical Affairs
Location:
United States - California - Foster City
Department:
Legal & Compliance Regular
Overview:
Ethics and Compliance Advisor to US Medical Affairs across all Gilead therapeutic areas. This position reports to the Senior Director/Director, US Ethics & Compliance Advisor.
Essential Duties and Job Functions: Work with the Senior Director to provide expertise in healthcare compliance ensuring that Medical Affairs activities align with the highest ethical and compliance standards.
Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Medical Organization.
Participate in activity reviews consistent with established policies and processes, advising on ethics and compliance insights and recommendations, including outreach to relevant stakeholders or subject matter experts when appropriate.
Advise on and support the business and other key stakeholders in operationalizing compliance processes and executing within legal and compliance-related requirements.
Develop and deliver trainings and educational sessions to enhance ethics and compliance understanding among stakeholders.
Recognize healthcare compliance risks and support the identification of mitigation controls to help address, as needed.
Partner as needed with Privacy and Data Ethics team to operationalize requirements related to data privacy, information security, cyber laws, industry codes.
Support and facilitate policy, training and communications, monitoring, risk assessments, due diligence, transparency, and other healthcare compliance needs.
Stay abreast of relevant ethics and compliance developments and industry trends. Work in partnership with the US Legal Business Partners and other Legal and/or Compliance teams to help ensure the organization operates within ethical and compliance frameworks.
Lead, inspire, and foster a high-performance culture.
Requirements We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Bachelor’s degree is required. A Juris Doctorate or fully qualified legal credentials in one or more geographies of operations is preferred but not required.
Extensive professional experience in-house in biotech, pharmaceuticals or other highly regulated industries or law firm advising in all relevant areas of practice for these industries. Ideally the majority of the years of career spent in-house.
9+ years of Compliance experience, with a BA/BS degree or 7+ years of Compliance experience, with an MS/MA or MBA, or PhD.
Management experience and ability to mentor and supervise a team of professionals.
Excellent verbal and written communication skills in English.
Knowledge, Experience and Skills Knowledge and experience in practices related to interactions between commercial, medical affairs and market access.
Invest time and effort in building strong relationships with relevant stakeholders. Act as a trusted advisor and cultivate a collaborative environment based on mutual respect and understanding.
Approach challenges with a problem-solving mindset.
Work together with colleagues across Legal and Ethics and Compliance teams to find ethical and compliant solutions.
Cultivate and display the ethics and values for which Gilead strives, and actively engage with stakeholders from a place of trust and partnership. Be firm when needed, even when working with more senior stakeholders.
Apply a deep understanding of the biopharma industry, Gilead's business objectives, and the specific challenges faced by different departments. This will enable the legal and compliance team to provide tailored and practical advice.
Respond promptly to inquiries, requests, or concerns raised by business stakeholders. Demonstrate a sense of urgency in addressing their needs and provide timely feedback.
Foster open and transparent communication channels with business stakeholders. Clearly communicate requirements, explain the rationale behind decisions, and provide regular updates on relevant changes or developments.
Continuously evaluate and improve internal processes to ensure efficiency and effectiveness in supporting the business in achieving company goals. Minimize unnecessary bureaucracy and simplify workflows to facilitate smooth interactions.
Embrace a culture of continuous improvement. Actively seek feedback from business stakeholders and strive to enhance the quality and effectiveness of support provided.
EEO Statement As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster.
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United States - California - Foster City
Department:
Legal & Compliance Regular
Overview:
Ethics and Compliance Advisor to US Medical Affairs across all Gilead therapeutic areas. This position reports to the Senior Director/Director, US Ethics & Compliance Advisor.
Essential Duties and Job Functions: Work with the Senior Director to provide expertise in healthcare compliance ensuring that Medical Affairs activities align with the highest ethical and compliance standards.
Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Medical Organization.
Participate in activity reviews consistent with established policies and processes, advising on ethics and compliance insights and recommendations, including outreach to relevant stakeholders or subject matter experts when appropriate.
Advise on and support the business and other key stakeholders in operationalizing compliance processes and executing within legal and compliance-related requirements.
Develop and deliver trainings and educational sessions to enhance ethics and compliance understanding among stakeholders.
Recognize healthcare compliance risks and support the identification of mitigation controls to help address, as needed.
Partner as needed with Privacy and Data Ethics team to operationalize requirements related to data privacy, information security, cyber laws, industry codes.
Support and facilitate policy, training and communications, monitoring, risk assessments, due diligence, transparency, and other healthcare compliance needs.
Stay abreast of relevant ethics and compliance developments and industry trends. Work in partnership with the US Legal Business Partners and other Legal and/or Compliance teams to help ensure the organization operates within ethical and compliance frameworks.
Lead, inspire, and foster a high-performance culture.
Requirements We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Bachelor’s degree is required. A Juris Doctorate or fully qualified legal credentials in one or more geographies of operations is preferred but not required.
Extensive professional experience in-house in biotech, pharmaceuticals or other highly regulated industries or law firm advising in all relevant areas of practice for these industries. Ideally the majority of the years of career spent in-house.
9+ years of Compliance experience, with a BA/BS degree or 7+ years of Compliance experience, with an MS/MA or MBA, or PhD.
Management experience and ability to mentor and supervise a team of professionals.
Excellent verbal and written communication skills in English.
Knowledge, Experience and Skills Knowledge and experience in practices related to interactions between commercial, medical affairs and market access.
Invest time and effort in building strong relationships with relevant stakeholders. Act as a trusted advisor and cultivate a collaborative environment based on mutual respect and understanding.
Approach challenges with a problem-solving mindset.
Work together with colleagues across Legal and Ethics and Compliance teams to find ethical and compliant solutions.
Cultivate and display the ethics and values for which Gilead strives, and actively engage with stakeholders from a place of trust and partnership. Be firm when needed, even when working with more senior stakeholders.
Apply a deep understanding of the biopharma industry, Gilead's business objectives, and the specific challenges faced by different departments. This will enable the legal and compliance team to provide tailored and practical advice.
Respond promptly to inquiries, requests, or concerns raised by business stakeholders. Demonstrate a sense of urgency in addressing their needs and provide timely feedback.
Foster open and transparent communication channels with business stakeholders. Clearly communicate requirements, explain the rationale behind decisions, and provide regular updates on relevant changes or developments.
Continuously evaluate and improve internal processes to ensure efficiency and effectiveness in supporting the business in achieving company goals. Minimize unnecessary bureaucracy and simplify workflows to facilitate smooth interactions.
Embrace a culture of continuous improvement. Actively seek feedback from business stakeholders and strive to enhance the quality and effectiveness of support provided.
EEO Statement As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster.
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