Medical Writer Job Listing at Belcan in Pine Brook, NJ
Materials & Construction, Media / Publishing
Job Number: 165219
Category: A - Immediate/Urgent Need
Description: Our client in Pine Brook, NJ has an immediate need for a Medical Writer!
? 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.
? Implements the medical communication strategy for all regulatory submission documents as assigned.
? Uses 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.
? Implements 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 that he/she is the author of.
Must have experience writing ISS, ISE, SCS and SCE documents
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 (ie 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 (eg 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.
Immediate long-term contract opportunity! Please send resume, references, and salary requirements to at firstname.lastname@example.org.
Requirements: Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract/temporary, temp-to-hire, and direct assignments in the technical, IT, professional, clerical, and light industrial fields. We are the employer of choice for thousands worldwide. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website athttp://www.belcan.com.
Location: Pine Brook , NJ
Minimum Experience (yrs): 6+
Required Education: Bachelor (BA, BS...)
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