Job Description - Medical Director - Psychiatrist (20003422)
Medical Director - Psychiatrist-(20003422)
with senior management, customers, and project teams to ensure the safety of
subjects in clinical trials; ensures the scientific integrity of the clinical
portions of clinical trials; provides medical input to clinical programs;
provides clinical development and regulatory consulting advice as needed. Performs the duties of a Medical Monitor.
subject safety and the scientific integrity of clinical trials.
Responsible for subject-safety and the scientific
integrity of clinical trials.
Performs the duties of a Medical Monitor.
Provides 24-hour coverage for clinical trials.
Participates in bids, bid-defenses & feasibility
assessments when requested.
Provides project-specific and therapeutic training to
sponsors and Company staff as needed.
Works with the Drug Safety Department by providing
medical input and oversight.
Works with Medical Writing/Regulatory in the
preparation of a variety of documents as required.
Maintains in-depth knowledge of worldwide drug
development regulations and Good Clinical Practice (GCP) guidelines.
Interacts with senior management, project management,
and other departments as appropriate.
Provides clinical development and regulatory
consulting advice both within Company and to clients as requested.
Locates and interacts with outside experts as
Provides feedback to management on quality issues within
the clinical trial team
Represents Company at scientific meetings as required.
Primary senior-level contact for customers.
line-management duties as needed.
work-related duties as assigned. Minimal travel may be required (up to
doctoral-level degree in psychiatric medicine and must have practiced psychiatric medicine and have
clinical research experience in psychiatry. In-depth
knowledge of FDA and worldwide drug-development regulations. Strong understanding of the use of medical
terminology and of drug-names in multiple nations, cultures and
environments. In-depth knowledge of
national and ICH Good Clinical Practice (GCP) guidelines. Basic computer and word-processing skills,
including the use of spreadsheets, e-mails and smart-phones. Experience working in matrix-teams. Ability to handle multiple tasks to meet
deadlines in a dynamic environment.
Effective organizational and interpersonal skills. Skilled at presenting data to groups, and in
the creation of effective documentary communication. Customer-focused with a disciplined approach
to work with excellent verbal communication and language skills. Fluency in written and spoken English.
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