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Work Background
MEDICAL DIRECTOR (Freelance consultant)
Andes Research S.p.AMEDICAL DIRECTOR (Freelance consultant)
Jan. 2022Santiago, Chile Research and Development. Implementation and Follow-up of Clinical Studies  Quality management of Clinical Research  Pharmacovigilance  Regulatory Affairs Management  Relationship with scientific community, Key Opinion Leaders, and Health Authorities.
REGULATORY DIRECTOR
Athenex Cidal Chile SpAREGULATORY DIRECTOR
Jan. 2018 - Jan. 2022 With responsibilities on implementation and control of clinical studies (Breast cancer studies phase 1 & 3)  Management of Regulatory process with MoH and Ethical Committees.  Pharmacovigilance  Writing of different protocol documents: ICF, protocol, IBs, lab guideline, monitoring plan, safety plan, final study report, scientific publications etc.
REGULATORY MANAGER
Cidal Chile SpAREGULATORY MANAGER
Jan. 2014 - Jan. 2018 With responsibilities on implementation and control of clinical studies  Management of Regulatory process with MoH and Ethical Committees Research and Development.
R&D COUNTRY MANAGER
Janssen Chile S.A.R&D COUNTRY MANAGER
Jan. 2010 - Jan. 2014 In charge of implementation and control of clinical studies.  Management of Regulatory process with MoH and Ethical Committees.  Pharmacovigilance
CLINICAL RESEARCH INDEPENDENT CONSULTANT
FreelanceCLINICAL RESEARCH INDEPENDENT CONSULTANT
Jan. 2008 - Jan. 2010 Advisor for Clinical Study Implementation  Good Clinical Practice Training.  Regulatory Affairs Management  Pharmacovigilance
MEDICAL DIRECTOR
Merck Sharp & Dohme Inc. (MSD)MEDICAL DIRECTOR
Jan. 1995 - Jan. 2007 Research and Development. Protocols in several therapeutic areas.  Product registration.  Pharmacovigilance  Relationship with scientific community, Key Opinion Leaders, and Health Authorities.  Scientific support to marketing and training. Regulatory Affairs Management
CLINICAL RESEARCH AUDITOR
Population councilCLINICAL RESEARCH AUDITOR
Jan. 1995 - Jan. 1995Santiago - Chile Auditing a long-term trial for Trans-cutaneous Contraceptives as preparation to an FDA audit. Five-year study Phase III in two sites, Santiago - Chile and Santo Domingo - República Dominicana.
CLINICAL RESEARCH ASSOCIATED
Schering A.G. BerlinCLINICAL RESEARCH ASSOCIATED
Jan. 1994 - Jan. 1995 Monitoring of Phase 1 Clinical Study.
MEDICAL DIRECTOR
Schering de Chile S.A., Subsidiary Schering A.G. BerlinMEDICAL DIRECTOR
Jan. 1986 - Jan. 1994 Medical director. In charge of Planning, implementing, and controlling clinical studies Phase I, II, III, and post-marketing.  Medical Affaire in charge of relationships with scientific community, Key Opinion Leaders, and Health Authorities.  Sales Force Training on scientific aspects.
MEDICAL DIRECTOR
Hormoquímica de Chile, Subsidiary of Organon InternationalMEDICAL DIRECTOR
Jan. 1985 - Jan. 1986 In charge of Planning, implementing, and controlling post-marketing clinical studies.  Medical Affairs in charge of relationship with scientific community, Key Opinion Leaders, and Health Authorities.  Sales Force Training on scientific aspects.
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