Senior Manager, Medical Affairs Operations

Edgewise Therapeutics

1d•$100,000 - $135,000

About The Position

The Senior Manager, Medical Affairs Operations provides operational infrastructure, project coordination, and administrative support so the Medical Affairs organization can plan, execute, and track its work effectively. The role partners across Medical Strategy, Scientific Communications, Medical Directors, and Field Medical, establishing processes and visibility across priorities, budgets, vendors, meetings, systems, and deliverables. The Senior Manager independently manages core business operations, including budget and invoice tracking, contracting and vendor workflows, operational planning, congress and meeting coordination, content-review administration, documentation, dashboards, and team operating routines. The role enables scientific and medical teams to focus on strategy, content, and external engagement. Accountability for medical strategy, scientific content, healthcare professional relationships, and field strategy remains with designated Medical Affairs leaders.

Requirements

Bachelor's degree in business, life sciences, healthcare, or a related field, or an equivalent combination of education and relevant experience.
At least 5 years of experience in pharmaceutical or biotechnology operations, Medical Affairs operations, program or project management, or a related function.
Demonstrated experience with budget tracking, forecasting, purchase orders, invoices, accruals, contracts, and vendor-management workflows.
Strong project-management and organizational skills, with the ability to independently manage multiple workstreams, deadlines, stakeholders, and changing priorities.
Working knowledge of pharmaceutical industry compliance requirements and operational processes involving healthcare professionals, vendors, and medical materials.
Excellent written and verbal communication skills and demonstrated ability to influence and drive follow-through without direct authority.
High proficiency with Microsoft Office and collaborative project-management and reporting tools.

Nice To Haves

Experience working in a small or mid-sized biotechnology company or another fast-paced, evolving environment.
Hands-on experience with Veeva Vault and/or Veeva CRM, Smartsheet, Power BI, or comparable content, project-management, and reporting platforms.
Experience coordinating congresses, advisory boards, external expert contracting, and Medical Affairs content-review workflows.
Experience developing SOPs, work instructions, dashboards, templates, and scalable operational processes.
Project-management certification or formal project-management training.

Responsibilities

Maintain an integrated view of Medical Affairs priorities, tactics, milestones, dependencies, and decisions across relevant teams.
Develop and maintain project plans, calendars, trackers, action logs, and risk registers; follow up with owners and escalate risks or resource constraints.
Coordinate annual and long-range Medical Affairs planning, including collection of functional inputs, consolidation of tactical plans, timeline management, and leadership updates.
Establish and support Medical Affairs operating routines, including leadership meetings, planning sessions, cross-functional reviews, and business updates.
Develop dashboards and reports showing activity status, budget performance, operational risks, and milestones.
Coordinate Medical Affairs budgeting and track forecasts, commitments, actuals, accruals, and variances with leadership and Finance.
Manage workflows for purchase orders, invoices, vendor setup, statements of work, contract routing, renewals, and closeout; resolve delays and discrepancies.
Maintain a centralized view of vendors, agreements, deliverables, and spend; support vendor performance reviews and resource planning.
Coordinate healthcare professional contracting, fair market value assessments, payment documentation, and related compliance requirements with relevant partners and medical owners.
Lead operational coordination for congress activities, including timelines, registrations, travel and meeting logistics, vendors, internal planning, and post-congress reconciliation.
Provide end-to-end operational support for advisory boards and other external medical meetings, including contracting, attendee logistics, venue and vendor coordination, material routing, documentation, payments, and closeout.
Coordinate internal Medical Affairs meetings and planning sessions, including scheduling, agendas, pre-reads, action capture, decision documentation, and follow-up.
Partner with scientific and medical owners on operational readiness while leaving scientific objectives, agendas, content, and external relationships to the appropriate Medical Affairs leads.
Coordinate content-review workflows, including submission preparation, routing, status tracking, metadata, approval documentation, expiration, withdrawal, and archiving; substantive review remains with designated reviewers.
Maintain organized, audit-ready repositories for plans, approved materials, meeting documentation, contracts, SOPs, work instructions, and governance records.
Serve as an operational contact for relevant Medical Affairs systems and tools, coordinating access, onboarding, training, issue resolution, and improvement with system owners and IT.
Support fit-for-stage Medical Information operations as needed, including inquiry tracking, approved-response library administration, documentation, and escalation workflows; scientific response ownership remains with the designated medical lead.
Develop, document, and improve Medical Affairs processes, SOPs, templates, and working practices to increase consistency, efficiency, compliance, and scalability.
Coordinate operational onboarding and offboarding for team members, including systems access, shared resources, required training, and team-process orientation.
Provide administrative and operational support to Medical Affairs leadership and the broader organization, anticipating needs and ensuring timely follow-through.
Liaise with Finance, Procurement, Legal, Compliance, IT, Clinical Development, Regulatory, Commercial Operations, and other relevant partners.
Identify operational bottlenecks and implement practical solutions that improve clarity, accountability, and execution without unnecessary process burden.
Promote a collaborative, service-oriented, and continuous-improvement mindset across Medical Affairs operations.