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Kevin Pinz
Company Manager at iCell Gene Therapeutics
Responsibilities
Drafting and editing high quality, medically accurate documents.
Submitting articles for publication in peer-reviewed medical journals.
Working with the Medical Director in preparing and submitting new drug applications to the FDA
Working within a team, in a collaborative and supportive role, yet taking the lead on key projects as needed. The Medical Writer will provide regulatory documents support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents, and effective implementation of the clinical writing process.
Salary commensurate with experience.
Qualifications
An advanced degree in life sciences, medicine, or related fields
At least 2 years of experience as a medical writer, with well-documented, proven medical writing experience in a pharmaceutical or clinical/contract research organization
Excellent writing, editing, and communication skills
Ability to quickly develop an understanding of company SOPs
Experience in writing IND documents for FDA submission
Knowledge of medical terminology, research methods, and statistical analysis
Ability to work independently and collaboratively with different teams
Familiarity with various document formats, styles, and standards
Attention to detail and quality
Creativity and problem-solving skills
Employment type
Part-time
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