- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Range $120000.00 - $130000.00 Salary Description Job Title : Manager, Clinical Affairs (Case Review Board) Manager Title: Senior Director, Clinical ... Job Description Summary: Reporting to the Director of Clinical Affairs , the Manager, Clinical ...and Abilities Required for This Job: Working knowledge of clinical study execution and patient screen /… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Description Job Title: Senior Associate, Clinical Research Supervisor/Manager Title: Senior Manager, Clinical Affairs Job Description Summary: The ... play a key role in proactively supporting the conduct of pre-market clinical studies and ensure compliance with all regulatory requirements. The ideal candidate… more
- Kenai Therapeutics (San Diego, CA)
- …Oversee the creation and execution of critical clinical documents, including study protocols, clinical study reports, investigator brochures, and safety ... the Chief Medical Officer (CMO), the Vice President of Clinical Operations is a senior leadership position...with travel requirements. The role will require travel to clinical study sites and external vendors as… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Clinical Affairs , Senior - Study Operations** In this role, ... planning and study execution Additionally, you will analyze clinical affairs operations, identifying areas for improvement and implementing corrective… more
- BeOne Medicines (Emeryville, CA)
- …the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents ... team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads...countries in assigned region in close collaboration with regional study start up team and regulatory affairs … more
- United Therapeutics (Research Triangle Park, NC)
- …team and other stakeholders to provide biostatistical resources for investigator-sponsored clinical studies and address internal/external investigator queries of ... input, conduct thorough reviews, and grant approval for submitted investigator-sponsored clinical studies , external investigator queries of UT databases,… more
- United Therapeutics (Research Triangle Park, NC)
- …creative and detail-oriented with deep expertise in regulatory submissions and writing, including clinical study reports, clinical study protocols, and ... manuscripts, posters, and several regulatory documents including but not limited to: clinical study protocols and reports, Investigator's Brochures, and safety… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …and support clinical teams conducting external analytical studies and clinical trials. Experience with clinical study protocol writing, data ... **Job Description Summary** Specialist, Senior Specialist, Medical Affairs is an...authoring, editing, and reviewing documentation of design history files, clinical trial master file(s) supporting regulatory submission registrations and… more
- United Therapeutics (Research Triangle Park, NC)
- …successful planning and completion of assigned projects, including clinical studies , registries, or other strategic study /departmental initiatives. + Lead ... for which transplant is not currently an option. The Senior Project Manager of Medical Affairs will...and performance expectations + Serve as primary contact during clinical study /project, including regular collaboration, conferences calls… more
- Abbott (Santa Clara, CA)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Senior Manager Medical Affairs ** **Working at Abbott** At Abbott, you can ... Directors to identify strategic areas of interest, cross-functional review of submitted study proposals, and upon approval, manage the studies from initiation… more
- Merck (North Wales, PA)
- **Job Description** **Role Summary:** The Global Senior Director Medical Affairs (GDMA) is a subject matter expert in their area of responsibility (eg, defined ... preferred) and recognized medical expertise + Experience in country/region medical affairs or clinical development + Strong prioritization and decision-making… more
- New York State Civil Service (Albany, NY)
- …No Agency SUNY System Administration Title The State University of New York - Senior Counsel - Health Affairs Occupational Category Legal Salary Grade NS ... campuses within the System. Under the leadership of the Senior Vice Chancellor for Legal Affairs and...to support the various SUNY medical centers, medical schools, clinical or faculty practice plans operated by SUNY, including:-… more
- Danaher Corporation (Boston, MA)
- …Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global ... interactions to secure product approvals. + Collaborate cross-functionally and globally with Clinical Affairs , R&D, QA, and Business Development to align… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced ... typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager Regulatory … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is accountable for overseeing data generation activities, including phase 4 clinical studies , providing coaching/mentorship to team managers, as appropriate. ... **Job Description** **About the role:** Join Takeda as the Senior Director, US Medical Affairs - Head...years of pharmaceutical industry experience; 7+ years of relevant clinical practice, research, academic + Experience with clinical… more
- Houston Methodist (Houston, TX)
- …to comply with institutional and program requirements of the Office of Graduate Studies and Trainee Affairs joint programs (to include management of development ... students' handbook guidelines and expectations, thoroughly understanding Office of Graduate Studies and Trainee Affairs joint programs policies and procedures.… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …and decision-making. + Oversee the design, conduct, and reporting of Medical Affairs studies , ensuring scientific integrity, regulatory compliance, and alignment ... The Senior Medical Director, Medical Affairs -...to proactively identify and address evolving medical needs in clinical practice. Ensures the medically appropriate use of investigational… more
- Amgen (Washington, DC)
- …and US Medical Strategies. + Supports the development and implementation of Medical Affairs clinical studies . + Supports Congress medical training, execution ... Join us and transform the lives of patients while transforming your career. ** Senior Medical Scientist, Medical Affairs - Dermatology - Rheumatology** **What you… more
- Lilly (Indianapolis, IN)
- …IIT proposals and publications, as requested Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) ... for the planning, startup and conduct of phase 3b/4 studies **,** as well as non clinical ...product. + Responsible for the scientific training of the clinical study team. + Acts as scientific… more
- BeOne Medicines (San Mateo, CA)
- …regional leadership team, provides strategic leadership, management, and/or mentorship to regional clinical study managers & regional clinical trial manager ... regular updates on portfolio progress in the region to senior management and Global Study and Program...+ Oversees the planning and management of the assigned clinical studies from feasibility through closeout activities… more
