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Senior Manager, Regulatory Affairs Archives
Our Client is committed to advancing oncology care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers.
Job Description
Responsible for ensuring that records within Regulatory Affairs are being managed in compliance with regulations and archiving best practices. The Senior Manager will also have responsibility for the management of department SOPs and Work Practices. Also, responsible for providing supervision to direct reports. The Senior Manager will provide management and leadership for Regulatory Archives in the strategic planning, distribution and archiving of global Regulatory submissions and correspondence. This position requires attention to detail and the ability to be proactive to user needs. It is expected to demonstrate the understanding of and ability to provide customer service across various business lines within the balance of assuring the confidentiality of the regulatory archives.
Responsibilities include: - Owns the maintenance of the Regulatory Archive (paper and electronic systems) by properly storing and retrieving documents in a timely manner according to processes and procedures.
- Functions as a key liaison between Regulatory customers and the archive information. Partners or directs customers to specific authoritative sources of information to satisfy specific information needs.
- Decision-maker for access to the collection of information of all media types and is a resource as a Subject Matter Expert for historical content of information processes.
- Process owner for the roles and responsibilities of the eArchive database. Oversees that all requests for archiving are completed and closed according to written procedures. Reviews metrics reports and uses metric reports to identify trends and needs for training.
Job Requirements- Must have 4-7 years of pharmaceutical industry experience with a minimum of 3 years working with GxP documentation.
- Bachelor Degree or equivalent experience. Working knowledge of global Regulatory submission experience is required.
Salary: up to $95K D.O.E. and potential bonus 13-17%
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?ihireCR32183?rockville?37 |
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