View all jobs
Sr. Scientific Medical Writer (Montville, NJ)
New York, NYSourcePro Search has a fantastic opportunity for a Senior Scientific Medical Writer with a leading pharmaceutical company in Montville, NJ.
This position offers an excellent compensation/benefits package as well as relocation assistance.
Description:
Act as the medical writing expert responsible for the research, writing and editing of study level and submission level documents. Provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
Responsibilities:
REQUIREMENTS:
This position offers an excellent compensation/benefits package as well as relocation assistance.
Description:
Act as the medical writing expert responsible for the research, writing and editing of study level and submission level documents. Provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
Responsibilities:
- 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 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 author 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.
- Mentor and coach associate scientific medical writers in the Global Medical Writing (GMW) department.
REQUIREMENTS:
- Master’s degree or equivalent with at least 4-5 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.
- PhD 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.
- Must have experience in developing clinical documents in support of regulatory submissions globally (i.e. multiple regions) in more than one therapeutic area.
- Must have an in depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA).
- Must have experience in electronic document management and electronic regulatory submissions, tools and standards.
- Demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.
- Must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Global Development organization.