Everest Clinical Research Services Inc.
Medical Writer
Everest Clinical Research Services Inc., Trenton, New Jersey, United States,
Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a
Medical Writer
for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.Key Accountabilities:Work closely with the Everest project team members assigned to the project to achieve project milestones according to the project timeline.Perform Everest internal QC procedures for clinical documents developed by other Medical Writers, such as clinical study protocols, Clinical Study Reports (CSRs), pharmacokinetic (PK) reports, statistical reports, integrated efficacy or safety summaries, patient narratives, manuscripts, posters, and abstracts.Act as a lead medical writer in the preparation of clinical documents or scientific publications.Perform literature searches to support senior medical writers.Perform document e-publishing for CSRs and other clinical/regulatory documents to ensure that the final medical writing product meets specific document publishing requirements and timelines.Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.Plan and carry out professional development.Qualifications and Experience:Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.At least two years' experience in medical writing practice, with experience in the pharmaceutical clinical trial environment.Experience with medical writing for clinical study reports for regulatory submission (preferred).Excellent understanding of clinical trials and common clinical trial statistical analysis methods (preferred).Demonstrated ability to understand medical information and results; able to communicate effectively, orally and in writing.Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.Well organized and able to work independently.Comprehensive skills in Microsoft Office applications and Adobe Acrobat.We thank all interested applicants; however, only those selected for an interview will be contacted.Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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Medical Writer
for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.Key Accountabilities:Work closely with the Everest project team members assigned to the project to achieve project milestones according to the project timeline.Perform Everest internal QC procedures for clinical documents developed by other Medical Writers, such as clinical study protocols, Clinical Study Reports (CSRs), pharmacokinetic (PK) reports, statistical reports, integrated efficacy or safety summaries, patient narratives, manuscripts, posters, and abstracts.Act as a lead medical writer in the preparation of clinical documents or scientific publications.Perform literature searches to support senior medical writers.Perform document e-publishing for CSRs and other clinical/regulatory documents to ensure that the final medical writing product meets specific document publishing requirements and timelines.Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.Plan and carry out professional development.Qualifications and Experience:Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.At least two years' experience in medical writing practice, with experience in the pharmaceutical clinical trial environment.Experience with medical writing for clinical study reports for regulatory submission (preferred).Excellent understanding of clinical trials and common clinical trial statistical analysis methods (preferred).Demonstrated ability to understand medical information and results; able to communicate effectively, orally and in writing.Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.Well organized and able to work independently.Comprehensive skills in Microsoft Office applications and Adobe Acrobat.We thank all interested applicants; however, only those selected for an interview will be contacted.Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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