Description

At Edgewise, we are focused on advancing novel, muscle-targeted therapeutics for serious cardiovascular and cardiometabolic conditions with significant unmet need. Leveraging our expertise in muscle biology and small molecule drug development, we are building a cardiovascular pipeline that includes programs for hypertrophic cardiomyopathy, heart failure and other serious cardiovascular diseases.

We’re building a passionate, experienced team committed to tackling complex scientific and clinical challenges and delivering meaningful outcomes for patients. If you’re looking to do work that matters, we’d love to hear from you.

About the Position:

The Senior Manager, Medical Affairs Operations provides the operational infrastructure, project coordination, and administrative support required for the Medical Affairs organization to plan, execute, and track its work effectively. This role serves as a trusted operational partner across Medical Strategy, Scientific Communications, Medical Directors, and Field Medical, creating clear processes and reliable 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 the designated Medical Affairs leaders.

Essential Job Duties and Functions:

Medical Affairs planning and project coordination

Maintain an integrated view of Medical Affairs priorities, tactics, milestones, dependencies, and decisions across Medical Strategy, Scientific Communications, Medical Directors, and Field Medical.
Develop and maintain project plans, calendars, trackers, action logs, and risk registers for key Medical Affairs initiatives; follow through with owners and escalate risks or resource constraints appropriately.
Coordinate the annual and long-range Medical Affairs planning process, including collection of functional inputs, consolidation of tactical plans, timeline management, and preparation of leadership updates.
Establish and support effective operating routines for the Medical Affairs organization, including leadership meetings, planning sessions, cross-functional reviews, and periodic business updates.
Develop fit-for-purpose dashboards and reports that provide clear visibility into activity status, budget performance, operational risks, and key milestones.

Budget, contracting, and vendor operations

Coordinate the Medical Affairs budgeting process and maintain accurate tracking of forecasts, commitments, actuals, accruals, and variances in partnership with Medical Affairs leadership and Finance.
Manage operational workflows for purchase orders, invoices, vendor setup, statements of work, contract routing, renewals, and closeout; proactively resolve delays and discrepancies.
Maintain a centralized view of Medical Affairs vendors, agreements, deliverables, and spend and support vendor performance reviews and resource-planning decisions.
Coordinate healthcare professional contracting, fair market value assessments, payment documentation, and related compliance requirements in partnership with Legal, Compliance, Finance, and designated medical owners.

Congress, advisory board, and meeting operations

Lead operational coordination for Medical Affairs congress activities, including master timelines, registrations, travel and meeting logistics, vendor coordination, 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 to ensure operational readiness while leaving scientific objectives, agendas, content, and external relationships with the appropriate Medical Affairs leads.

Systems, workflows, and documentation

Coordinate Medical Affairs content-review workflows, including submission preparation, routing, status tracking, metadata, approval documentation, expiration, withdrawal, and archiving; substantive medical and compliance review remains with designated reviewers.
Maintain organized, audit-ready repositories for Medical Affairs plans, approved materials, meeting documentation, contracts, SOPs, work instructions, and governance records.
Serve as an operational point of contact for relevant Medical Affairs systems and tools, coordinating user access, onboarding, training, issue resolution, and continuous improvement with system owners and IT.
Support fit-for-stage Medical Information operations as needed, including intake and inquiry tracking, approved-response library administration, documentation, and escalation workflows, while 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.

Team enablement and cross-functional partnership

Coordinate operational onboarding and offboarding for Medical Affairs team members, including systems access, shared resources, required training, and team-process orientation.
Provide high-quality administrative and operational support to Medical Affairs leadership and the broader organization, anticipating needs and ensuring timely follow-through.
Serve as a key operational liaison 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 adding unnecessary process burden.
Promote a collaborative, service-oriented, and continuous-improvement mindset across Medical Affairs operations.

Required Education, Experience and Skills:

Minimum qualifications

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.

Preferred qualifications

Experience working in a small or mid-sized biotechnology company or other 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.

Salary range: $100,000-$135,000, title and salary commensurate with experience.

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.

Senior Manager, Medical Affairs Operations

Description

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