Principal Scientist

Principal Scientist needs Minimum of 4-6 years in a pharmaceutical organization or related industry with a minimum of 2-3 years pharmaceutical experience in a clinical safety or regulatory affairs

Principal Scientist requires:

Master Degree or PhD in Medical Science, Pharmacy or Nursing preferred.

• Minimum of 2-3 years of medical writing experience (Prefer experience in writing pharmaceutical reports such as PSURs, Clinical Study Reports, safety sections of the ISS and/or Common Technical Document, or white paper) and/or experience in Medical Surveillance and Risk Management.
• Proven understanding of clinical disease state and implications of treatment.
• At ease with data and statistics.
• Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance
  (experience with world-wide safety reporting regulations and guidelines) and Risk Management.

Required

• CLINICAL SAFETY
• CLINICAL STUDY
• CLINICAL TRIAL
• PHARMACOVIGILANCE
• CLINICAL TRIALS

Principal Scientist duties:

• Work with others to determine topics for discussion in Section 9; prepare first draft of Section 9 for Medical Director review
• Follow-up on issues identified in regulatory responses (e.g., assessment reports)

$95/hr

12 MONTHS