Medical Writer

(Job Id W314233)
Posted on 3/7/2010
Location:

Philadelphia, PA;


Job Type:

Full Time


Salary: $90000.00 to $110000.00/year
Degree: Master of Science
Job Description
Job Description
The Principal Medical Writer researches, writes, edits, and coordinates the production of documents associated with clinical regulatory submissions, including clinical study protocols, Investigators Brochures, clinical study reports, briefing packages, and New Drug Applications. This individual participates on clinical study teams as the lead Medical Writer for multiple studies, including entire development programs. The Principal Medical Writer independently identifies and solves challenges and performs innovative functions in support of the Medical Writing function. The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.

The Principal Medical Writer creates an effective communication strategy within and across documents in a program. This individual interprets and summarizes complex data, including data across multiple studies and phases. The Principal Medical Writer plans and manages medical writing resourcing for a development program and participates in the selection and management of contract Medical Writers for outsourced projects. The Principal Medical Writer maintains a high level of knowledge related to current developments in the field and may supervise other Medical Writing staff.
Minimum Requirements Ideal applicants possess outstanding written communication skills, a solid understanding of clinical data analysis, advanced knowledge of researching, writing, editing, and reviewing clinical documents, and a strong record of innovative problem-solving. Applicants must exhibit highly developed skills in teamwork, organization, project management, and oversight of contractors. Preferred candidates have a Ph.D. (or equivalent degree) and at least 5 years of relevant work experience, an M.S. and at least 6 years of relevant work experience, or a B.S. and at least 8 years of relevant work experience.