Regulatory Affairs Medical Information Specialist

Our client is a leading specialty pharmaceutical company that develops, manufactures and markets prescription pharmaceuticals.

 

Job Responsibilities:

? Respond to medical and technical questions from health care professionals and consumers

? Responsible for all processes related to medical information inquiries

? Responsible for telephone and written communication with health care professionals

? Assist in the creation of resource documents that summarize pertinent clinical information

? Support the Regulatory Affairs activities for designated projects and participate in the preparation of regulatory submissions.

? Prepare and maintain appropriate regulatory documents

? Review regulatory submissions involving clinical studies

? Participate in new product evaluation and development

 

Job Qualifications: 

? BS degree in Pharmacy with a state-Registered Pharmacist license. Pharm.D (or equivalent) would be preferred.

? At least one year experience in clinical pharmacy or related medical information experience

? Excellent communication skills required to listen effectively to callers, clarify the nature of the information requested and respond accordingly.

? Experience in preparing regulatory documents and conducting clinical studies preferred.

 

 Compensation: $70,000.00 (Higher compensation commensurate with experience. Excellent benefits and relocation package)

 

For confidential consideration, please forward your resume in a Word document to