Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best talent for the job.
Qualifications
Principal Scientist needs a minimum of 4-6 years in a pharmaceutical organization or related industry with a minimum of 2-3 years pharmaceutical experience in 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
- 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).