Role Summary
The Senior Manager, US Ethics & Compliance Advisor, HIV Treatment is a hybrid/office based role located in Foster City, CA. The US Ethics and Compliance Advisor acts as a business partner providing actionable compliance guidance to the US Commercial HIV Treatment business unit and reporting to the US Ethics and Compliance Lead for HIV.
Responsibilities
- Support the execution of the US Healthcare Compliance Program consistent with industry standards.
- Work with the Senior Director advising HIV Treatment Commercial providing real-time solutions oriented guidance on HCPs/HCOs interactions, speaker programs, advisory boards and field activities.
- Work proactively identifying emerging issues early and working with the Senior Director to implement preventive controls rather than reactive solutions.
- Apply knowledge and experience in practices related to interactions between commercial, medical affairs and market access.
- 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 enterprise risk and support the identification of mitigation controls to help address, as needed.
- Consult on business activities and initiatives that pose compliance considerations, working closely with the legal and Ethics and Compliance teams who provide primary support for relevant business functions, 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 compliance needs.
- Stay abreast of relevant ethics and compliance developments and industry trends. Work in partnership with the Gileadβs Legal team and other Legal and/or Compliance teams to help ensure the organization operates within ethical and compliance frameworks.
- Lead, inspire, and foster a culture of compliance and integrity.
Qualifications
- Required: Eight years of Compliance experience, with a BA/BS degree or 6+ years of Compliance experience, with an MS/MA or MBA.
- Required: 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.
- Required: Management experience and ability to mentor and supervise a team of professionals.
- Required: Excellent verbal and written communication skills in English.
- Required: Knowledge and experience in practices related to interactions between commercial, medical affairs and market access.
- Required: Ability to exercise judgment and propose courses of action where precedent may not exist.
- Required: An inquisitive mind with good analytical, critical thinking, and problem-solving skills.
- Required: Initiative and adaptability in a fast paced environment.
Skills
- Strong relationship-building with relevant stakeholders; act as a trusted advisor in a collaborative environment.
- Ability to work with colleagues across Legal and Ethics and Compliance teams to find ethical and compliant solutions.
- Clear communication of requirements and rationale; provide timely updates on changes or developments.
- Continuous improvement mindset to enhance internal processes and support.
Education
- BA/BS required; MS/MA or MBA considered an asset.