Senior-Principal Medical Writer

Job Description

Senior Medical Writer

Full-time Regular

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 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:

• Work with the sponsor’s and/or medical personnel and statisticians to develop/write clinical development plans, clinical study protocols, clinical study reports, and other documents, as appropriate


• Create template/shell for integrated clinical study report based on ICH guidelines and sponsor’s standards and in accordance with the study protocol


• Hold review meetings to discuss edits provided by the team and/or the sponsor, as needed


• Write journal articles, abstracts, and posters in cooperation with responsible statisticians and/or the sponsor


• 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


• Perform other duties as assigned

EDUCATION

• Bachelor’s degree in a scientific discipline is required


• Graduate degree is preferred

EXPERIENCE

• Minimum of 10 years of experience in medical writing with a minimum 5 years regulatory writing in biotechnology/pharmaceutical industry

SKILLS

• 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.