Senior Manager, US Medical Affairs, Patient Access and Quality of Care
Gilead Sciences
1 month ago
On-site
San Francisco Bay Area
Medical Affairs
Responsibilities:
- Coordinate Medical Review Committee (MRC) submissions (preparation, tracking, revisions, final approvals) for PAQ medical materials; manage timelines, feedback incorporation, and documentation/version control for audit readiness and compliance.
- Lead updates to scientific decks and medical materials for accuracy, consistency, and alignment with approved data/messaging; coordinate review cycles, versioning, and stakeholder input.
- Oversee external vendor coordination (timelines, deliverables, quality checks) for medical content development/execution; support vendor onboarding, contracting coordination, and compliance alignment.
- Create and maintain medical resources aligned with PAQ scientific objectives, payer evidence needs, and field team requirements (content development, formatting, review coordination, publication, cataloging).
- Provide logistical/operational support for Medical Affairs Advisory Programs (MAAPs) and Sentinel Panels; coordinate agendas/materials/meetings and post-meeting follow-up, including payer-focused engagements and PAQ conferences.
- Manage dossier updates to reflect current data/indications and payer-relevant evidence; maintain FormularyDecisions.com content (uploads, updates, compliance tracking, review/approval workflows).
- Project manage PAQ HIV budget tracking/updates (forecasts, accruals, vendor spend tracking) with finance and leadership.
- Maintain knowledge management systems (SharePoint sites, resource libraries, indexes) and improve internal workflows.
- May prepare and give presentations for internal training and/or external audiences.
- Collaborate cross-functionally in a compliant manner.
Basic Qualifications:
- Master’s degree and 6 years of experience OR
- PhD/PharmD and 2 years of experience.
Preferred Qualifications/Skills:
- 1+ year Medical Affairs (pharma/medical devices), managed care, or HEOR experience; ideally including a successful product launch.
- Advanced life sciences degree (PharmD, MS/MPH, PhD, or MD/DO).
- Health outcomes/research/medical affairs background in HIV.
- Hands-on, urgent, fast-paced environment mindset.
- Solid regulatory/compliance knowledge.
- Strong organization, project planning, and time management; urgency and goal orientation.
- Excellent written/verbal communication; ability to present to diverse audiences.
- Strong interpersonal skills; teamwork and timely decision-making in a matrix environment.
- Strategic thinking and ability to lead ideation → plan → execution.
- Computer proficiency: Excel, Word, PowerPoint, Adobe.
- Ability to travel frequently (+/-30%).
People Leader Accountabilities:
- Create Inclusion, Develop Talent, Empower Teams.
Benefits (if eligible):
- Company-sponsored medical, dental, vision, and life insurance plans.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.
- Coordinate Medical Review Committee (MRC) submissions (preparation, tracking, revisions, final approvals) for PAQ medical materials; manage timelines, feedback incorporation, and documentation/version control for audit readiness and compliance.
- Lead updates to scientific decks and medical materials for accuracy, consistency, and alignment with approved data/messaging; coordinate review cycles, versioning, and stakeholder input.
- Oversee external vendor coordination (timelines, deliverables, quality checks) for medical content development/execution; support vendor onboarding, contracting coordination, and compliance alignment.
- Create and maintain medical resources aligned with PAQ scientific objectives, payer evidence needs, and field team requirements (content development, formatting, review coordination, publication, cataloging).
- Provide logistical/operational support for Medical Affairs Advisory Programs (MAAPs) and Sentinel Panels; coordinate agendas/materials/meetings and post-meeting follow-up, including payer-focused engagements and PAQ conferences.
- Manage dossier updates to reflect current data/indications and payer-relevant evidence; maintain FormularyDecisions.com content (uploads, updates, compliance tracking, review/approval workflows).
- Project manage PAQ HIV budget tracking/updates (forecasts, accruals, vendor spend tracking) with finance and leadership.
- Maintain knowledge management systems (SharePoint sites, resource libraries, indexes) and improve internal workflows.
- May prepare and give presentations for internal training and/or external audiences.
- Collaborate cross-functionally in a compliant manner.
Basic Qualifications:
- Master’s degree and 6 years of experience OR
- PhD/PharmD and 2 years of experience.
Preferred Qualifications/Skills:
- 1+ year Medical Affairs (pharma/medical devices), managed care, or HEOR experience; ideally including a successful product launch.
- Advanced life sciences degree (PharmD, MS/MPH, PhD, or MD/DO).
- Health outcomes/research/medical affairs background in HIV.
- Hands-on, urgent, fast-paced environment mindset.
- Solid regulatory/compliance knowledge.
- Strong organization, project planning, and time management; urgency and goal orientation.
- Excellent written/verbal communication; ability to present to diverse audiences.
- Strong interpersonal skills; teamwork and timely decision-making in a matrix environment.
- Strategic thinking and ability to lead ideation → plan → execution.
- Computer proficiency: Excel, Word, PowerPoint, Adobe.
- Ability to travel frequently (+/-30%).
People Leader Accountabilities:
- Create Inclusion, Develop Talent, Empower Teams.
Benefits (if eligible):
- Company-sponsored medical, dental, vision, and life insurance plans.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.