Medical Writer Job Listing at CTG in Pine Brook, NJ (Job ID ctg-12205857)
Software Development, Consulting
Title: Medical Writer
Location: US-NJ-Pine Brook
Job Number: 12205857
Our global client is seeking a contract Medical Writer for a long term project at its Montville, NJ facility. The successful candidate will act as the medical writing expert responsible for the research, writing and editing of study level and submission level documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission. Responsibilities will include assuring quality and timely preparation of clinical documents across all therapeutic areas as assigned, including clinical study reports, clinical study protocols, investigator’s brochures, clinical summaries and overviews.
* Assist the GMW TAH in the development of clinical document content used to support successful global clinical development, approval and marketing of a drug
* Implement the medical communication strategy for all regulatory submission documents as assigned
* Use the Global Target Label (GTL) and all associated product strategy documents to effectively develop associated clinical documents in support of the Global Clinical Development Plan (CDP), validate individual study protocol design and clinical study report (CSR) key messages, and provide key messages for submission dossiers used to gain marketing approval for the assigned documents
* Implement project level data presentation and messaging standards for the assigned documents
* Independently authors submission and study level documents (collaborating with the team) based on the strategy provided and is accountable for the format, content and adherence to global and electronic publishing standards of the individual submission documents of which he/she authors
* Bachelor’s degree or equivalent with at least 5-6 years of experience in the pharmaceutical industry in total, including a minimum of 4 years in Medical Writing and demonstrated working knowledge of scientific principles
* Master’s degree or equivalent with at least 3-4 years of experience in the pharmaceutical industry in total, including a minimum of 3 years in Medical Writing and demonstrated working knowledge of scientific principles
* PhD degree or equivalent with at least 2-3 years of experience in the pharmaceutical industry in total, including a minimum of 2 years in Medical Writing and demonstrated working knowledge of scientific principles
* The incumbent must have experience in developing clinical documents in support of regulatory submissions globally (i.e. multiple regions) in more than one therapeutic area
* The incumbent must have an in depth understanding of all regulatory guidances, standards and requirements pertaining to regulatory medical writing world-wide (e.g. ICH, FDA, EMEA)
* The incumbent must have experience in electronic document management and electronic regulatory submissions, tools and standards
* The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas
* The incumbent must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Global Development organization
Please no Corp to Corp or 3rd party vendors.
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
Criminal Background check and drug screen is required.
CTG is an Equal Employment Opportunity employer.
Job: Technology & Healthcare IT
Contest Number: 12205857
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