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Profession: Nursing
Specialty: Quality Assurance/Management
Company: Medical Staffing Network
Openings: 4
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Updated: 9/5/2010
Job Type: FullTime
Pay Range:
Not Provided
Start Date: 1/1/1753
End Date: 1/1/1753
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Description: Regulatory Affairs Manager
Our client is a biopharmaceutical company focused on the discovery, development, and commercialization of novel immunotherapies designed to reprogram the immune system and provide a long-term, durable remission after a short course of therapy. They were recognized as one of Boston's outstanding employers by the Boston Business Journal.
Job Description:
We are seeking a successful, highly motivated individual who will be responsible for the collection and filing of paper and electronic submissions to Regulatory Authorities (ex. FDA, HC, EU, etc). A major focus of this position is in support of moving company towards electronic regulatory submissions.
Responsibilities for this position:
- Review of document format to assure compliance with regulations and electronic standards. Maintenance of regulatory archive for storage of final, signed off versions of submissions, saving submissions to the appropriate electronic file, and updating the associated submission tracking log (s) for US, EU, etc.
- Develop and maintain proficiency in compliance with current guidance on electronic submissions.
- Work with Senior Management in the development and recommendation of vendors for electronic submissions (eCTD, SPL, REMS, etc).
- Develop and maintain project timelines for regulatory submissions.
- Create and maintain appropriate regulatory SOPs.
- Train personnel on electronic processing as appropriate.
- Participate in GXP audits to assure regulatory compliance as needed.
Job Requirements:
- Bachelors degree, preferably in life sciences.
- 3 - 5 years of direct regulatory experience in the Pharma/Biotechnology industry.
- Previous experience with electronic submission software and publishing systems is desired.
Salary: Depends on Experience
Medical Staffing Network is one of the largest and most reputable Clinical Research staffing agencies. As an MSN employee, you'll receive great pay and top benefits.
Why choose Medical Staffing Network? - 401K
- Major Medical, Vision and Dental Insurance
- Life Insurance and Short Term Disability
- Liability and Workers' Compensation
Enjoy: Great locations/ prestigious facilities Exclusive partnerships
APPLY NOW, email your CV or resume to clinicalresearch@msnhealth.com, or contact us at (877) 605-2500.
For quick consideration apply here: http://www.cytiva.com/ihire/ext2/applya.asp?ihire?ihireCR34602?rockville?28
Facility: MSN Health
Facility Address:
Boston, MA
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Posted By: Medical Staffing Network
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In just seven years, Medical Staffing Network has grown to become a national leader in healthcare staffing, with over 120 locations nationwide. This enables MSN to offer nurses, allied health, pharmacy, clinical research and anesthesia professionals a variety of flexible opportunities at thousands of top facilities nationwide. We were also the first national-level healthcare staffing firm to have received Joint Commission certification, which we obtained in 2005 and again in 2006.
In addition to competitive pay rates, Medical Staffing Network offers healthcare professionals many of same benefits they'd receive as a staff employee—with the added flexibility and choice that comes with working with a staffing firm. Opportunities are available on a local per diem, travel, temp-to-perm or contract basis. Benefits can include health insurance, malpractice insurance, matching 401(k), free online continuing education credits, direct deposit, bonuses and more. We have the power to offer healthcare professionals opportunities that smaller firms can't. For more information or to apply online, visit www.MSNHealth.com or call 800-MSN-TEAM (676-8326).
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