Quality Assurance jobs in United States

The Clinical Operations and Medical Projects Lead will support the Director of Medical Affairs in managing the operational aspects of Medical Affairs activities across the Asia Pacific and Middle East region. These activities include, but are not limited to, investigator-sponsored trials, scientific engagements with health care providers, and medical projects, ensuring operational excellence and tracking of medical initiatives.

• Support execution of study contracts between Investigative institutions and Guardant, coordinating external/internal review promptly.
• Support the medical affairs team in the review of new study proposals received from the investigators. Keep documentation and track the progress.
• Participate and drive clinical study discussions internally and externally.
• Periodically review the study progress and ensure that it is running as per protocol, and explore potential interim analysis.
• Keep all study trackers updated.

• Collaborate with the medical affairs team in planning scientific meetings or other expert engagement activities by providing operational/logistical support, including communication with vendors, offices of academic conferences, or other third parties.
• Work closely with partners to track invoices and facilitate payment through finance.

• Own the medical tracking systems, insight management tools, and digital enablement platforms.
• Drive adoption and continuous improvement of these tools to enable data-driven decisions and strategic agility.
• Willingness to use digital tools and improve efficiency continuously.

• Develop and manage documents, including contracts/agreements, and invitation letters for medical affairs lead meetings.
• Manage the process for the service provider from onboarding to payment.
• Provide medical writing for advisory board and other meetings. Aspire to support medical writing for case reports/ full manuscripts.
• In consultation with the medical affairs team, review the Guardant database to come up with suggestions for landscape analysis by tumor/ mutation. Propose interesting cases for publication.
• On a need basis, develop or update scientific slides on relevant topics.

• Degree in a scientific field of study (Bachelor's or Master's degree or equivalent in a relevant healthcare-related field such as B.Sc, B.Pharm, M.Pharm, M.Sc).
• Minimum of 4 years of experience in Clinical Operations in CRO, biotech, or pharmaceutical organizations.
• Project management experience of 4 years in pharmaceutical/ biotech/CRO.
• Medical writing in the pharmaceutical, diagnostics, or biotech industry preferred.

• Applies good knowledge of the pharmaceutical, diagnostics, or biotech industry.
• Advanced knowledge of the following computer software programs: Microsoft Office, PowerPoint, Excel, and Word.
• Fundamental understanding and experience of AI agents (ChatGPT, Co-pilot).
• Highly developed written skills, the ability to produce high-quality documents for dissemination both inside and outside the organization.
• Evidence of writing/ driving scientific publications preferred.
• Ability to work independently and remotely while maintaining a strong teamwork ethic.
• Multi-dimensional in abilities to work on simultaneous tasks, work in a high-paced, high-energy environment.
• Ability to work cross-team and at different levels of the organization, whether internal or external relationships to the organization.
• Self-directed, intrinsically motivated, flexible to changes in an ever-changing dynamic environment.
• Strong problem-solving skills, good attention to detail, time management skills, and personal initiative.
• English language proficiency.

This is an office-based role with occasional (<10%) travel for work.