FDA Consulting for Pharmaceutical Company

Posted on by PRN | 2 Comments

There is an opening for a physician to provide consultation and support preparation of regulatory submissions for phase 2a projects in CHF, Endocrinology, and COPD. This position is of limited duration and highly focused for chronic heart failure or chronic obstructive lung disease associated with wasting.

The work is with a rapidly growing, top-25 pharmaceutical company that offers a high degree of latitude and empowerment to its employees and consultants in the execution of its clinical trial operations.  Much of the work is outsourced to third parties, with in-house and consulting staff managing project timelines and deliverables.  Combine this entrepreneurial environment with industry-leading rates and these openings represent one of the best consulting projects available right now in Northern NJ.  Client will consider reimbursing travel and temporary living expenses for persons not local to Northern NJ.

Medical Consultant, FDA Submissions
Status:   Full-time consulting engagement, 40-60 hrs/week
Length:  2-3 month project, on-site in Northern NJ
Rate: Client wants the best, and will pay competitive hourly rates for the most experienced applicants

Requirements:  10+ yrs experience with a research based pharma / biotech company.   MD degree, with an active US license plus experience in chronic heart failure, chronic obstructive pulmonary disease and/or endocrinology is required.  Experience in regulatory submissions/strategy is essential.  Excellent working knowledge of clinical trial design and FDA and EU regulations.   Strong writing, communication and team working skills.  Previous positions of leadership within clinical development organizations highly desirable.  Experienced retirees from the industry and from the FDA are encouraged to apply.  A retired pulmonologist or cardiologist with good drug development experience would also be very attractive.

If you are interested in this position, please contact us at info@prnresource.com, and we will pass along your information to the recruiter loking to fill this position.

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