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Job Information
Job title

Medical Writer

Company Technisource
Wage between $0.00 - $0.00 Annually
Location United States, New Jersey, Ridgefield Park
Employment type Full Time
Education Not Specified
Year Experience 4 - 5 Years of Practical Experience
Travel Not Specified
Published on 9/15/2009
Description

The contract Medical Writer (MW) works directly with International Project Team (IPT) members with the goal of writing scientifically valid, complete, and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigators Brochures (IBs) primarily, and select submission documents, Clinical Development Plans, and other regulatory documents secondarily, as workload permits. Actively participates in the process to ensure the timely submission of high quality, critical documentation both within and outside of company.

Key Job Responsibilities:

Prepares regulatory documents on behalf of customer for the ultimate purpose of regulatory agencies, in accordance to ICH guidelines and CFR as applicable, standards and processes, and AMA Medical Writing styles, adhering to study/project timelines.Actively participates in study and/or project team meetings to provide input regarding deliverables, timelines, and any process(es) needed for the completion of regulatory documents. Administrates as appropriate, the receipt, collation, and incorporation of review comments needed for completion of regulatory documents.

QUALIFICATIONS:

Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and qualityProficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.Electronic Document Management System (eDMS, eg, Documentum) skillsApplies good judgment and demonstrates initiative to resolve issuesStrong verbal, written and interpersonal communication skills needed to work effectively in a team environment.At least 5 years writing experience in the pharmaceutical industryBachelors degree in life sciences disciplineMasters degree in life sciences preferred

Candidate will work 2 days a week on site/3 days a week at home

Interested candidates please forward a copy of your resume to (see below)



Required Skills:
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Experience/Skills
See Above

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