Senior Manager, US Medical Review

Are you ready to elevate scientific rigor in US promotional and medical review so healthcare professionals receive accurate, balanced, and compliant information that ultimately improves patient outcomes? This role puts you at the center of how we communicate evidence and safety, shaping the quality and credibility of materials used across the field and digital channels.

As the senior medical review leader, you will connect clinical data to real-world impact by guiding PRC/MRC decisions, accelerating compliant content, and strengthening trust across teams. You will collaborate with medical, marketing, legal, regulatory, and communications partners to translate complex evidence into clear, fair claims that stand up to scrutiny. How will you use your expertise to help us deliver timely, compliant, and meaningful content for people living with rare and devastating diseases?

• Medical Review Leadership:
  Serve as the primary medical reviewer on PRC and MRC, delivering scientifically accurate, reference-supported assessments of promotional materials, medical materials, internal training content, and field communications.
• Claims and Evidence Assessment:
  Evaluate claims, data citations, study designs, and safety information for accuracy, balance, and compliance with FDA and other applicable standards to protect scientific integrity.
• Decision Documentation:
  Document review outcomes within established review systems (e.g., Veeva Promo Mats), including clear rationale for required revisions to enable fast, compliant execution.
• Timely Delivery and Workload Management:
  Ensure timely completion of medical review assignments within defined SLAs and workload metrics, prioritizing high-impact materials.
• Therapeutic Area Intelligence:
  Maintain current, in-depth knowledge of assigned therapeutic areas, clinical data, competitor landscape, and disease‑state developments to inform reviews and guidance.
• Literature Review and Insight Generation:
  Conduct literature reviews to confirm scientific accuracy and support internal decision‑making, translating findings into actionable direction for cross‑functional partners.
• Cross‑Functional Analytics:
  Support generation of therapeutic area workload metrics and analytics for forecasting and resource planning to optimize capacity.
• Internal Presentations and Training:
  Participate in internal presentations (e.g., medical information inquiry insights, congress booth medical training, procedures training) aligned to product and review responsibilities to strengthen scientific understanding across teams.
• Data Verification and Quality Compliance:
  Assist with verification and fact‑checking of data used in Medical Affairs content, and report product quality complaints and adverse events to Quality Assurance/Drug Safety in accordance with corporate requirements.
• Operational Excellence:
  Contribute to operational initiatives such as SOP creation/updates, training modules, and system/database enhancements to scale best practices.
• Medical Communications Partnership:
  Provide support to Medical Communications (Medical Education, Scientific Communications) when consistent with role capacity and priorities, ensuring consistent, accurate messaging.

• Advanced scientific degree:
  Pharm
  
  D, PhD, or MD.
• 3+ years of experience in Medical Information, Medical Communications, or related function in the pharmaceutical/biotech industry.
• Demonstrated understanding of:
• Drug development processes
• FDA promotional regulations and medical review standards Global reporting requirements for pharmacovigilance and product quality complaints

• Direct medical review experience on an MLR/PRC/MRC or equivalent committee.
• Experience in academia, or in pharmaceutical/biotech industry.
• Experience with promotional/medical material review platforms (e.g., Veeva or Promo Mats).
• Experience developing or reviewing Medical Affairs content.
• Experience in rare disease, immunology, nephrology, hematology, neurology, enzyme-replacement therapies, or related therapeutic areas.
• Experience supporting product launches.
• Completion of a post-Pharm
  
  D industry fellowship.

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