SUMMARY OF POSITION: The Regulatory Writer is responsible for researching, writing, and editing materials for regulatory submission and support of the clinical program. PRIMARY RESPONSIBILITIES:
Works with data management, clinical, toxicology and CMC, as well as sponsors and KOLs to review protocol development and regulatory strategy and interpret clinical trial data
Authors in eCTD format every type of Regulatory submission in pharma and med tech: Briefing packages of all types, INDs (both original and amendment housekeeping), Module 2 NDAs (clinical and non-clinical sections), pre-Subs, CSRs, IBs, PSPs
Conducts complex literature searches, finalizes into written summaries for NDA Safety sections, or for PMA annual updates
Assists other writers in the compilation, writing, and editing of regulatory, scientific manuscript, marketing deliverables, and trade journal articles.
Manages multiple, concurrent projects
Ensures quality of content and format of writing projects in accord with applicable regulations, guidelines, and corporate SOPs
REQUIRED SKILLS AND ATTRIBUTES:
Strong medical and/or scientific writing skills
Ability to work well in a team environment, with the ability to work effectively independently
Efficient project management skills
Strong knowledge of FDA regulatory requirements, Good Clinical Practice (GCP) and ICH guidelines, including strong familiarity with the eCTD format a plus
OTHER REQUIREMENTS:Bachelor’s degree in applied or life science or communications, with 3+ years of medical, regulatory, or clinical writing experience in the pharmaceutical or biotech industry, or equivalent training and work experience. An advanced degree is preferred. Ophthalmology experience a plus. For a senior position: Bachelor’s degree in applied or life science or communications, with 5+ years of medical, regulatory, or clinical writing experience in the pharmaceutical or biotech industry, or equivalent training and work experience. An advanced degree is preferred. Ophthalmology experience a plus. Applicant for a senior position should have strong knowledge of FDA regulatory requirements, Good Publication Practice (GPP) and ICH guidelines, including strong familiarity with the eCTD is required. Applicant should require only minimal instruction and refer independently to pre-established guidelines to perform the functions of the job.Please note this position is a part of a career ladder- all level of experience encouraged to apply.