Roseann Murray
Lead Regulatory Affairs @ Hansa Biopharma | Regulatory Strategy
- Role
- Director, Clinical Medicine at Takeda
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Roseann Murray
Experienced pharma professional with focus in regulatory science. Proven track record of success designing, developing and executing critical components of clinical trials/regulatory packages: site relationship management, protocol concept development, driving development of critical documents (Investigators’ Brochure, Protocol, amendments, regulatory document clinical sections, responses to Health Authority questions, CSR), liaising with health authorities. Working knowledge of ICH and GCP guidelines, trial design, statistics, clinical development process/Clinical Development Plan. Interpret, discuss and represent data. Multidisciplinary and international team experience. Effective communicator, mentor and leader within multidisciplinary matrix framework.
Experience
Director, Clinical Medicine
Jan 2020 — Present · Cambridge, MA, US
Education
Columbia University Mailman School of Public Health
M.P.H, work. Epidemiology
1994 — 1995
Harvard University
Ph.D, Biological Sciences in Public Health
1995 — 2002
Universidad Nacional Autónoma de México
B.S, Biology
1990 — 1993
Skills
- CRO
- Pharmaceutical Industry
- Sop
- Fda
- Edc
- Therapeutic Areas
- Ctms
- Vaccines
- Biomarkers
- Immunology
- Assay Development
- Ind
- Clinical Trials
- Clinical Development
- Project Management
- Oncology
- Protocol
- Molecular Biology
- Medical Writing
- Infectious Diseases
- Medicine
- Clinical Monitoring
- Regulatory Submissions
- Leadership
- Microbiology
- Medical Affairs
- Drug Development
- Clinical Research
- Gcp
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