Temporary Medical Writer

The Temporary Medical Writer is responsible for various medical writing initiatives.  The person in this role is responsible for ensuring all documents are written in accordance with applicable regulations and completed on time.   

Job responsibilities:

• Provide medical/regulatory writing and editing expertise for study reports and regulatory submission documents and in particular compile and summarize data for briefing book for regulatory meetings, investigator brochures, and IND applications
• Write, review, and edit preclinical pharmacology, pharmacokinetic and toxicology technical documents for organization, clarity, language/grammar, consistency, and scientific standards
• Coordinate, synthesize, and integrate scientific and medical input from internal and external contributors to meet deliverable and publication deadlines for regulatory documents, as well as manuscripts, abstracts, and presentations for scientific meetings and publications.
• Author documents while contributing expertise, knowledge/skills related to clinical drug development, and scientific/technical expertise
• Experience in performing medical-database searches (e.g., Medline, PubMed, etc.).
• Experience as primary author on scientific publications.

Skills & Requirements:

• IND, CTA and IB writing experience required
• Knowledge of FDA and EMEA regulations, GCP and ICH guidelines desirable
• Excellent computer skills with experience using Microsoft Word (Word, Excel, PowerPoint) applications to prepare charts, tables, reports and presentations. Experience with email and calendar programs also required.
• 5+ years medical writing experience. Industry medical writing experience strongly preferred
• Life Sciences degree required.
• Experience with regulatory toxicology studies (in vitro/in vivo) and/or a PhD/MS in Life Sciences is a plus

What is the last date for applying to the job?

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