PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance.
We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market.
Our clients include national and international biopharmaceutical and medical device companies of all sizes.
RESPONSIBILITIES
The Medical Writer I 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 Medical Writer I will :
- Work with PROMETRIKA’s medical personnel and statisticians to develop clinical study protocols, clinical study reports, and other documents, as appropriate
- In collaboration with the Principal of Medical Writing, create template / shell for integrated clinical study report based on ICH guidelines and sponsor’s standards and in accordance with the study protocol
- Attend review meetings to discuss edits provided by the PROMETRIKA team and / or the sponsor, as needed
- Write journal articles, abstracts, and posters in cooperation with responsible statisticians
- Develop / write clinical sections of INDs, NDAs, and other submission documents
- Write investigator brochures
- Prepare annual reports and briefing documents for regulatory submission
- Manage consistency of style, format, and content for all IND and NDA documents within a given project
- Learn and develop deep understanding of clinical research process and relevant documents
- Perform other duties as assigned
EDUCATION
Bachelor degree in a scientific discipline is required, graduate degree is a plus
EXPERIENCE
Minimum of 5 years of experience in development in a pharmaceutical / biotech / CRO company and good writing skills. Regulatory writing experience a plus.
SKILLS
- Knowledge of ICH recommended content of Investigator Brochure, Clinical Study Report, IND, and NDA. Previous involvement in writing at least one protocol and Clinical Study Report is preferred.
- Good word processing skills
- 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.
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