Medical Writer
- Choudhary Job Services
- 2 to 7 Yrs
- Multi-City, India
- 3 years ago
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Job Description
Like many other technical writers, medical regulatory writers must coordinate with various technical professionals to gather, organize and compile information on new products or processes. Many regulatory medical writers work for either biomedical or pharmaceutical development companies, compiling the paperwork necessary to submit new drugs and therapies for review by the FDA and other organizations.
These regulations can vary significantly. FDA guidelines state, according to section 312.23 of the Code of Federal Regulations, that Investigational New Drugs (IND) require the submission of a document that includes sections on the protocol for each planned study, chemistry and manufacturing information, toxicology information, previous human experience with the drug and any additional information. In addition to these initial submissions, the FDA might request carefully formatted safety reports throughout the IND process. These are only some examples of the duties that a regulatory writer must fulfill
Employement Category:
Employement Type: Full timeIndustry: Medical / Healthcare
Role Category: Pharmacist / Medical Representative
Functional Area: Not Applicable
Role/Responsibilies: Medical Writer
Contact Details:
Company: Vinay Kumar SinghLocation(s): Multi-City, India
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