Manager, Medical Affairs

This is a fully remote position, open to applicants in New York.

📋 Description

• Act as the clinical and medical device subject matter authority for product development, implementation, training, risk assessment, complaint analysis, and lifecycle management.

• Offer clinical knowledge to teams in Clinical Research, R&D, Marketing, Regulatory Affairs, Quality, Manufacturing, Legal, and Commercial sectors.

• Assist with risk assessments, clinical evaluations, quality standards, and design history documentation.

• Analyze clinical evidence, literature, and emerging healthcare trends.

• Convert customer insights and clinical experiences into product and business recommendations.

• Recognize unmet clinical needs and create innovative solutions in collaboration with cross-functional teams.

• Aid in post-market surveillance, complaint assessments, and benefit-risk evaluations.

• Formulate and implement Medical Affairs strategies.

• Collaborate on initiatives for evidence generation, investigator-initiated studies, research partnerships, registries, publications, and scientific congress programs.

• Interpret and share clinical evidence regarding product safety, effectiveness, and value.

• Design and conduct training programs on scientific, clinical, and medical devices.

• Educate on disease states, clinical workflows, product applications, and healthcare trends.

• Support customer-oriented education, product launches, implementation initiatives, and controlled market introductions.

• Oversee Medical Affairs projects, ensuring timelines, deliverables, and cross-functional activities are managed efficiently.

• Aid in planning, portfolio assessments, resource forecasting, governance, project tracking, and leadership reporting.

• Assist with budgets, forecasts, accruals, financial reporting, vendor relations, contracts, purchase orders, invoices, and budget oversight.

• Ensure adherence to company policies, regulations, and industry standards.

• Maintain documentation and practices that are ready for inspection.

• Create dashboards, project updates, operational metrics, leadership presentations, program summaries, budget reports, and strategic updates.

• Monitor project performance and utilize data to promote continuous improvement.

⛳️ Requirements

• Bachelor's degree in a clinical, scientific, healthcare, or related field.

• At least 5 years of experience in Medical Affairs, Clinical Research, healthcare, medical devices, pharmaceuticals, or similar healthcare sectors.

• Proven experience in managing complex projects with multiple stakeholders.

• Excellent communication, presentation, organizational, and interpersonal abilities.

• Experience in supporting budgets, contracts, vendors, and operational processes.

• Capability to manage multiple priorities effectively and work independently in a dynamic environment.

• Proficient in Microsoft Office applications and project management tools.

• Willingness to travel domestically and internationally as business needs arise (up to 30-50%).

• Applicants must have authorization to work for any employer in the U.S.

• An advanced clinical or scientific degree (NP, PA, MD/DO, DNP, or equivalent) is preferred.

• Active clinical licensure in good standing is preferred.

• Previous Medical Affairs experience in the medical device, diagnostics, digital health, or healthcare technology sectors is preferred.

• Experience in supporting evidence generation, publications, investigator-sponsored research, and scientific communications is preferred.

• Familiarity with financial management systems, procurement platforms, and vendor oversight is preferred.

• PMP certification or comparable project management training is preferred.

🏝️ Benefits

• Medical and dental coverage starting on day one.

• Basic life insurance.

• Accident insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• Business travel accident insurance.

• Employee Stock Purchase Plan (ESPP) with discounted company stock.

• 401(k) Retirement Savings Plan with employee contributions and company matching.

• Flexible Spending Accounts.

• Educational assistance programs.

• Paid holidays.

• Paid time off ranging from 20 to 35 days based on length of service.

• Family and medical leaves of absence.

• Paid parental leave.

• Commuting benefits.

• Employee Discount Program.

• Employee Assistance Program (EAP).

• Childcare benefits.