- Sanofi Group (Cambridge, MA)
- …Coordinate with CRDs in the project, Global Project Head, The PV Rep, Regulatory + Provide expertise in the fields of clinical development and autoimmune conditions. ... safety, stat outputs of blinded data, ) with clinical scientist , bio stat and GSO + Lead the study...to medical questions raised by EC/IRBs, sites **Contribution to regulatory and safety documents and meetings:** + Represents his/her… more
- Takeda Pharmaceuticals (Boston, MA)
- …diseases with high unmet medical. We are seeking an experienced research scientist and drug hunter to lead biology and cross-functional drug discovery teams ... and/or pipeline progression + Be a highly collaborative and energetic scientist with superior communication skills, who can balance multiple, collaborative projects… more
- Sumitomo Pharma (Boston, MA)
- …highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more
- Sanofi Group (Cambridge, MA)
- …The GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label, as appropriate. ... Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the...statistics, CMC, IA **Basic Qualifications:** + Medical doctor or doctor/ scientist + More than 5 years of clinical or… more
- Bristol Myers Squibb (Boston, MA)
- …programs. Key responsibilities of this role are to act as a lead scientist to implement and deliver on biomarker strategies for clinical programs, develop reports ... on translational data generated to support asset development and contribute to regulatory submissions. This individual will work on cross-functional project teams to… more
- Amgen (Cambridge, MA)
- …deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key Responsibilities: + **Design Transfer Execution:** Develop and ... closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure alignment and successful design transfer. +… more
- Sanofi Group (Cambridge, MA)
- …new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development ... + The Senior COA Lead actively participates in the regulatory and commercial dynamic specific to TA, defines and...direct accountability of some assets with support of COA scientist . + Expertise: The Senior COA Lead delivers senior… more
- Bristol Myers Squibb (Cambridge, MA)
- …Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management ... disease area and relevant science in order to meet regulatory and disease strategy targets + Provides oversight and...the literature + Keep s abreast of development and regulatory issues related to other competitive or relevant compounds… more
- Sanofi Group (Cambridge, MA)
- …new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development ... (including vendor management) + Prepare the scientific documents (reports, regulatory documents, publications, ) for internal and external communication Specific… more
- Sanofi Group (Cambridge, MA)
- …teams, Digital Endpoint Strategy Leads, Project Leads, Study managers, Procurement, Regulatory , Quality, and others. . Lead and contribute detailed project ... analysis, and integration of digital data. . Share scientific, operational, and regulatory knowledge relevant to digital biomarkers. . Assist in building validation… more