SUMMARY OF POSITION:
Responsible for researching, writing, and editing materials for regulatory submission. As a senior member of the regulatory writing team, needs minimal instructions and refers independently to pre-established guidelines to perform the functions of the job.
PRIMARY RESPONSIBILITIES: Works with data management and clinical operations groups to review and interpret clinical trial data Compiles, writes, and edits regulatory materials (IND/NDA), with specific emphasis on clinical study reports, investigator brochures, and SAE narratives Assists other writers in the compilation, writing, and editing of regulatory materials Manages review and revision processes for multiple, concurrent projects Ensures quality of content and format of publications in accord with applicable regulations, guidelines, and corporate SOPs
REQUIRED SKILLS AND ATTRIBUTES: Strong knowledge of FDA regulatory requirements, Good Publication Practice (GPP) and ICH guidelines, including strong familiarity with the eCTD 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
OTHER REQUIREMENTS: 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.
Please note this position is apart of a career ladder- all level of experience encouraged to apply.