What are the responsibilities and job description for the Principal Scientist position at Global Channel Management, Inc.?
Company Description
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 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)
Additional Information
$95/hr
12 MONTHS
Salary : $95
