- Sanofi Group (Cambridge, MA)
- …stretch the limits of what you thought was possible. Ready to get started? The Senior Clinical Research Director (Sr CRD) is noted as the **primary clinical lead for ... deliver to multiple operational tasks. The role of the Senior CRD is to: + Act as a mentor...and/or contribute in the the clinical section of the Investigator 's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP +… more
- AbbVie (Cambridge, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description We are seeking a Senior Director with deep expertise in Neuropsychiatry to lead our Discovery Research ... preclinical study reports and documents to support Regulatory (IND/ CTA) filings, Investigator Brochures, and clinical study protocols and lab manuals. + Works… more
- Pfizer (Cambridge, MA)
- **Job Summary** The Senior Medical Director provides clinical development leadership and expertise for late-stage thoracic oncology clinical trials directly, and/or ... assessment, data review and safety monitoring. + Lead peer-to-peer interactions with investigator . + Serve as the point of contact for clinical issues between… more
- ICON Clinical Research (Boston, MA)
- As a Senior CRA (ONC) you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Roles and ... in site feasibility and/or pre-trial site assessment visits. + Attends/participates in investigator meetings as needed. + May serve as Lead CSM for specific… more
- Deloitte (Boston, MA)
- …case dispositions + Holding meetings with Project Leadership to discuss investigator performance, issue management, and case escalation decisions + Providing ... related software + 4+ Years Experience submitting written and oral reports to senior management and clients + Bachelor's degree in Finance, Business, Law, Criminal… more
- Merck (Boston, MA)
- …+ Worldwide marketing applications + Clinical study protocols and reports + Investigator brochures + Local registration study protocols for secondary markets + ... Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide strategic regulatory input and approvals. + Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. +… more
- Pfizer (Cambridge, MA)
- …the development and management of clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plan, and regulatory ... documents. + Provide leadership to early stage clinical scientists on the clinical study team for Early Development Assets, working in a matrix team environment with other clinicians, statisticians, clinical pharmacologists, translational biologists and… more
- WuXi AppTec (Boston, MA)
- …review as SOP and protocol required + Function as a Principal Investigator , responsible for pathology-related activities + Conduct planned, long-term education and ... training for junior pathologists + Communicate with sponsors to answer questions and discuss results regarding the pathology report. + Provide consultation to Study Directors on studies. + Ensure the compliance of various GLPs, comply with protocol and SOPs… more
- Merck (Boston, MA)
- …and to improve outcomes for patients. The EDSA leads a large investigator -initiated studies program in partnership with late-stage development teams in Medical ... Congress summary reports. **Primary Responsibilities:** + Leads our Company's Investigator Initiated Studies program in assigned therapeutic areas ensuring… more
- Sumitomo Pharma (Boston, MA)
- …evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. **Job Duties and Responsibilities** + ... Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator communications (Dear Health Care Provider… more