Medical and Regulatory Writers Needed!

Job Type:     Contract
Base Pay:     Commensurate with experience
Minimum Education:     Bachelor’s (preferably PharmDs, PhDs)
Required experience:   Entry to senior level
Location:    Orlando, FL (remote work available)
Job Requirements:

Basic Knowledge / Core Requirements:

• Basic pharmacology, medical science and therapeutics
• Excellent written and oral communication skillsets
• Proficient in the use of Microsoft Office products (MS Word expertise highly desirable)
• Proficient in the use of reference programs
• Knowledge of various style guides, eg, AMA

Responsibilities:

• Responsible for the preparation of all regulatory documents per ICH/FDA/GCP guidelines related to clinical research, investigational new drugs (INDs) and new drug application submissions (NDAs).  This will include preparation of common technical documents (CTDs) clinical study reports, investigator’s brochure, clinical protocols, investigational plans, patient narratives, summaries of pharmacokinetic and toxicology studies, clinical safety and efficacy summaries, etc.
• Responsible for manuscript preparation including literature search, development, and publication.  
• Participate in the review of data and creation/design of templates documents
• Others: develop SOPs, product brochures, targeted messaging, etc.
• Editorial review and copy-writing of documents written by others on staff. 
• Must be willing to learn and/or have extensive knowledge of FDA and ICH regulations involving clinical research and associated documents.
• Ability to solve problems with MS Word templates
• Create stylized templates within FDA guidelines
• Interact with new and existing clients via conference calls (and onsite if client requests

If interested, please send your CV/ resume and some work samples (if any) to hr@accelarx.com.