Medical Affairs Project Manager - Cardiovascular Launch
hace 5 días
Somerville
Medical Affairs Project Manager 12 month contract with probability of extensions hybrid - Raritan, NJ (3 days onsite per week) ASAP start Role Summary We are seeking an experienced Contract Medical Project Manager to support the planning and execution of a Cardiovascular product medical launch. This role will drive operational excellence, ensuring medical launch workstreams are scoped, sequenced, tracked, and delivered on time while maintaining alignment with medical governance, compliance, and scientific integrity. The ideal candidate brings strong pharma/biotech project management expertise, hands-on experience in Medical Affairs launch readiness, and comfort working in a matrixed, fast-paced environment spanning Medical Affairs, Global & regional partners, Alliance partners and cross functional colleagues (Clinical, Market Access, and Commercial) Key Responsibilities 1. Medical Launch Program Management (Core) • Build and maintain the medical launch integrated project plan, including milestones, dependencies, critical path, and key deliverables., • Drive execution across medical workstreams such as:, • Scientific platform / medical narrative, • Field Medical launch readiness, • Congress planning and execution (e.g., major CV congresses), • Medical education (non-promotional), training logistics, and resource coordination, • Publications / data dissemination planning, • RWE/HEOR evidence plan coordination (as applicable), • Establish and run launch tracking cadences (weekly/biweekly), ensuring action items, decision logs, and risk registers are current and actionable. 2. Cross-Functional Coordination & Stakeholder Management • Act as the hub for cross-functional coordination between Medical Affairs and internal partners (Clinical, Regulatory, Safety, Market Access, Commercial, Legal/Compliance, Vendor teams)., • Facilitate core team and working group meetings: prepare agendas, pre-reads, minutes, action logs, and ensure follow-through., • Identify misalignments and proactively escalate risks/issues with proposed options and impact assessments. 3. Global support for regional readiness • Support country launch readiness, • Coordinate intake and tracking for country launch needs (e.g., Field medical onboarding, training, FAQs, objection handling/scientific exchange tools, medical information needs, and congress support). 4. Governance, Compliance & Quality • Ensure deliverables follow appropriate medical governance pathways (e.g., review workflows, documentation standards, version control)., • Track material development status, review cycles, and approvals (without authoring promotional claims). 5. Reporting, Dashboards & Launch Excellence • Develop and maintain simple, executive-ready dashboards for medical launch readiness, including:, • Milestone progress (RAG status), • Risk and issue management, • Decision/action tracking, • Resource and vendor status (where applicable), • Capture launch learnings and best practices; support post-launch retrospectives and continuous improvement. Deliverables (Typical Outputs) • Generation & Maintenance of Integrated Medical Launch Plan (e.g. MSP plan with timeline and GANTT charts), • Weekly/biweekly Status Reports to Launch Team and VP, • Executive-level summaries, • Risk/Issue/Decision logs (RAID), • Meeting artifacts (agendas, minutes, action trackers, stakeholder follow-up), • Field Medical readiness tracker (training plan, materials status, deployment timelines), • Congress program tracker (deadlines, booth/meeting support coordination, symposia timelines as applicable) Required Qualifications • Bachelor’s degree in life sciences, pharmacy, public health, nursing, or related field (advanced degree a plus)., • 5+ years project/program management experience in pharma/biotech; 2+ years directly supporting Medical Affairs initiatives., • Demonstrated experience supporting pre-launch/launch activities (medical launch readiness strongly preferred)., • Understanding of Cardiovascular therapeutic area concepts and typical medical launch needs (e.g., outcomes data, guideline context, unmet need, real-world evidence relevance)., • Strong matrix leadership skills: able to influence without authority and manage multiple stakeholders., • Excellent written and verbal communication; able to produce tight, executive-ready summaries. Preferred Qualifications • Experience with cardiovascular/metabolic launches (e.g., antithrombotics, lipid lowering, heart failure, hypertension, diabetes-CV risk)., • Familiarity with major CV congress workflows (planning, deadlines, medical content review)., • PMP, PRINCE2, Agile certification, or equivalent., • Experience managing vendors (medical communications, congress agencies, training vendors)., • Experience working in alliance/co-development environments. Key Skills & Competencies • Medical launch readiness and operational execution, • Project planning, RAID management, and timeline discipline, • Stakeholder management in complex matrix structures, • Strong attention to detail; governance and documentation rigor, • Calm execution under ambiguity and shifting priorities Time Commitment & Working Model (30 hrs/week) • 40 hours/week with potential for heavier weeks near major milestones (e.g., congress deadlines, approval/label timing, launch readiness gates)., • Flexibility to support core team meeting hours across [time zones, if applicable]., • Expected responsiveness: [e.g., same-day for priority launch items].