FierceBiotech and FiercePharma Jobs
Manager, Medical Affairs - verna scientific
Categories: Clinical
Website: http://www.vernascientific.com
Position Description
This is an excellent opportunity to be a part of a growing team and work in a progressive environment, Please contact me at your earliest convenience.
Urgent requirement for one of our top clients located in “Monmouth Junction, NJ”.
Please contact me at your earliest convenience, along with job No. MMA_80608 to glenn.davis@vernascientific.com
Description:
Manage preparation and compilation of regulatory filings, including Investigational Device Exemptions, Clinical Trial Authorization requests to Competent Authorities, as well as related amendments, supplements, annual reports, etc. Specific knowledge of clinical trial requirements for drugs; Capable of managing multiple projects.
Act as a liaison between the company and the Registration Agencies, Competent Authorities, Notified Bodies, or other regulatory bodies responsible for registrations and marketing applications.
Requirement:
Minimum of eight years experience within the regulated industry (Medical Device and/or Pharmaceutical); experience with orthopedic products a plus. Working knowledge of clinical development processes with particularly attention to the laws, regulations, guidance documents, and clinical practices for Medicinals. Knowledge of medical devices and quality systems requirements a plus. Effective communication skills essential.
How to Apply
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must) to ***glenn.davis@vernascientific.com*** Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.Application Instructions / Send a Resume
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