Top Tech Jobs & Startup Jobs in Boston, MA

Lead and manage outsourced analytical development and QC activities for inhaled drug substance and product. Oversee method development/transfer, review external lab data, support release and stability programs, maintain reference standards, investigate OOT/OOS trends, coordinate logistics, and collaborate with cross-functional CMC, QA, and regulatory teams to support regulatory submissions.

Manage regulatory documentation, publishing, QC, archiving, and submissions (IND/NDA/BLA) using Veeva RIM and DocuBridge. Implement SOPs, ensure timely, validated submissions, and collaborate with regulatory, CMC, and project teams. Hands-on formatting and operational leadership required.

Manage day-to-day clinical study operations including timelines, enrollment metrics, TMF QC, monitoring oversight, vendor/CRO management, study planning and system setup, and ensure GCP/ICH compliance.

Provide global regulatory strategy and support for clinical development and approval of pulmonary therapies. Prepare and review regulatory submissions, liaise with health authorities, guide cross-functional teams, track commitments, and contribute to labeling, policy, and due diligence.

Lead accounting functions including monthly/annual financial reporting, clinical trial accruals, budgeting/forecasting, internal controls, audit coordination, and manage an accounting team to support strategic decision-making.