Top Tech Jobs & Startup Jobs in Boston, MA

Contract safety writer to prepare BLA safety assessment reports, draft responses to FDA information requests, develop safety-related SOPs, support integrated safety summaries and risk-benefit analyses, review adverse event data, and assist with inspection readiness in collaboration with PV, clinical, regulatory, biostatistics, and medical teams.

Lead cross-functional CMC program management for a cell therapy candidate through late‑stage development and licensure. Develop integrated program plans, manage timelines, budgets, CDMO partners, risks, governance, and stakeholder communications. Mentor direct reports and drive delivery of CMC deliverables for regulatory milestones.

The role involves providing legal counsel on commercial agreements, compliance, regulatory matters, and strategies for a biotech company. Responsibilities include reviewing contracts, advising on healthcare compliance, and offering legal guidance for commercialization efforts.

Lead global safety and pharmacovigilance strategy for cell therapy programs, oversee PV operations (case processing, signal detection, reporting), ensure regulatory compliance, manage vendors and safety databases, support regulatory submissions and inspections, and drive benefit-risk assessments and post-marketing safety planning.