Top Echelon Network
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Job Location: Allentown, PA
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Major Pharmaceutical Company - known for their Vaccine Division is looking for a Medical Writer for their US Headquarters in Swiftwater, Pennsylvania
Must have 3-10 years industry experience writing for Clinical Research Phase 1-4 (not writing for abstracts, journals or marketing)
Position is located In-house in Swiftwater office daily
Relocation is available
Detailed Description
This position serves as a member of the Clinical Team. He/she is responsible for the production of key documents related to CD&MA activities (e.g. protocol, ICSR, IB, etc) in line with Company document standards.
In addition to project responsibility, will work with appropriate functions (e.g. Regulatory Affairs) to develop and maintain document standards, in line with the Company e-document strategies.
Responsible for the production of the key documents related to CD&MA activities, in line with Company document standards. Documents written include study protocols, ICSR, Clinical Expert Reports, ISS, and ISE. The incumbent does not write all sections, but collaborates with other team members to ensure that the relevant function representative produces appropriate sections. Coordinates input from expert contributors to these documents to ensure that timelines are met. Works with minimal supervision. Delivers reports to agreed project plans.
Participates as a member of the Clinical Team accountable to the Clinical Team Leader for all project issues.
Works with Company colleagues (e.g. in Regulatory Operations - Document & Dossier Production section) to ensure that Clinical documents are produced to the standard required for the dossier
Contributes to the development of document templates & relevant SOPs
Provides mentoring support to less experienced colleagues and new Company staff members.
BA/BS in Biology, Life Science, or related field of study, and 3-5 years of experience.
Demonstrated experience in clinical development, strong interpersonal, time management and technical writing skills. <>
More About the Position :
ANY experience writing for vaccine trials is a HUGE plus!!!
American Medical Writers Association
Clinical Medical Writing (not freelance writers)
Regulatory writing experience <>
Additional Details
The ideal candidate has worked for these companies:
MedImmune
GSK
Novartis
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