The Senior Medical Writer position requires writing and editing of clinical and scientific reports including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews, abstracts, posters, and other projects requiring skill in written communication. The Senior Medical Writer will also assist with and contribute to departmental leadership initiatives, training initiatives, business development efforts and organizational thought leadership. The Senior Medical Writer will:
- Knowledge of ICH recommended content of Investigator Brochure, Clinical Study Report, IND, IND updates and NDA along with previous involvement in writing at least one NDA or BLA is required.
- Knowledge of electronic document platforms is desired
- Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred
Physical Requirements
Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.
The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidateโs work experience, education/training background and parity with current employees in the same or similar positions.