- Datavant (Boston, MA)
- …understand how Datavant's solutions can solve their challenges in clinical trials, regulatory submissions , and real-world data generation. **You Will:** + Serve ... retrieval, with expertise in real-world evidence, clinical trial operations, or regulatory data submission. + Excellent communication skills with the ability to… more
- Bristol Myers Squibb (Cambridge, MA)
- …+ Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed ... activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives… more
- Prime Therapeutics (Boston, MA)
- …efficiencies through process improvements for paralegal services + Manage regulatory submissions , filings, renewals, notifications, and periodic reports ... Review (UR), business and state registrations) + Research and respond to regulatory inquiries + Other duties as assigned **Minimum Qualifications** + Paralegal… more
- Novo Nordisk (Lexington, MA)
- …to small molecules; preparation and review of non-clinical safety sections of regulatory submissions as relevant; propose & oversee external collaborations & ... molecule pipeline + Ensure alignment with relevant GxP requirements and regulatory standards + Collaborate with cross-functional teams to integrate safety strategies… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream ... processing. + Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with… more
- Takeda Pharmaceuticals (Boston, MA)
- …on the validity of COA endpoints and produce COA evidence dossiers for regulatory submissions . + Prepares and/or reviews clinical and outcomes research ... analysis plans, scientific reports, briefing packages, clinical study reports, and regulatory labelling interactions. + Provide technical expertise and guidance on… more
- Dana-Farber Cancer Institute (Boston, MA)
- …tracking systems (STIP) and laboratory binders. + May be responsible for IRB and regulatory submissions and maintenance of regulatory files. **For Bone ... external outcomes data repositories, including national repositories when required by regulatory requirements and US law. + Ensure case management documentation in… more
- ICON Clinical Research (Boston, MA)
- …findings to cross-functional teams and contribute to scientific publications and regulatory submissions . **Leadership & Collaboration:** + Mentor junior ... or single-cell imaging technologies. + Familiarity with clinical sample handling and regulatory standards. + Prior work in oncology, immunology, or neuroscience is a… more
- Nanobiosym, Inc. (Cambridge, MA)
- …IP-related matters, including licensing agreements, collaborations, M&A due diligence, and regulatory submissions . + Dispute Resolution: Support IP litigation, ... strategies. + Prior in-house legal experience in a biotech or pharmaceutical company. + Familiarity with regulatory frameworks (eg, FDA, EMA) as they relate to IP. more
- J&J Family of Companies (Danvers, MA)
- …and constructively challenging the status quo + Basic understanding of medical device regulatory submissions + Dedicated, passionate and eager to learn + Sound ... develop supply chain phase-in plans accounting for various medical device regulatory approval timelines + Qualify and implement dimensional and visual inspections… more
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