- AbbVie (Irvine, CA)
- …and AbbVie study staff. + Responsible for understanding and addressing applicable regulatory requirements related to the clinical studies, clinician reported ... interpretation, presentation and reporting of scientific protocols, Investigator Brochures, Clinical Study Reports, Clinician Reported Outcome Dossiers, regulatory… more
- AbbVie (Cambridge, MA)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other ... to augment expertise in the therapeutic area. + Responsible for understanding the regulatory requirements related to the clinical studies and global drug… more
- ConvaTec (Lexington, MA)
- …into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as ... Management, Site Management, Data Management / Data Analytics), Global Head of Clinical Operations, R&D, Regulatory and executive leadership as needed External… more
- AbbVie (North Chicago, IL)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other ... reputation as an industry leader. + Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug… more
- Pfizer (Cambridge, MA)
- …or supports other critical documents, eg, protocol amendments, investigator brochure, and regulatory documents. + Collaborate with Clinical Operations to ensure ... regarding strategy and/or data, and may assist with authoring clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR). + Support… more
- AbbVie (North Chicago, IL)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other ... May represent AbbVie at key external meetings. + Responsible for understanding the regulatory requirements related to the clinical studies and global drug… more
- AbbVie (Irvine, CA)
- …interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other ... area. May represent AbbVie at key external meetings. *Responsible for understanding the regulatory requirements related to the clinical studies and global drug… more
- Bristol Myers Squibb (Princeton, NJ)
- …working with disease and lab scientists, as well as BMS members from clinical , medical, commercial, regulatory , and diagnostics. Individual will also engage with ... development process; including experience with implementing a biomarker strategy + Clinical protocol authoring and review of regulatory documents. +… more
- Roche (Pleasanton, CA)
- …designs + You will serve as the clinical thought leader for the regulatory clinical product requirements and clinical development strategies as well as ... multidisciplinary functions involved in a company's product development process, eg, clinical operations, biostatistics, regulatory , commercial, etc. and can… more
- Bristol Myers Squibb (Cambridge, MA)
- …board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects + ... Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and… more