Medical Writer. Pay:$55/hr W2.
Nauticasoft invites resumes from Medical Writer to help our large client. Pay:$55/hr on W2. Location: Waukegan, IL. Note: This is 38 hours per week & a Six month onsite contract. Candidate must be legally authorized to work on W2 with out sponsorship. (EOE). 1099 or corp-to-corp candidates are NOT eligible for this position. If you meet the below skills please send your resume to firstname.lastname@example.org Primary Function The Senior Medical Writer is responsible for providing scientific publications to the clinical teams and effective implementation of the clinical writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (eg, PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications. Major Responsibilities * Implements all activities related to the preparation of scientific publications (eg. Abstracts, posters/oral presentations, manuscripts). * Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing projects. * Serves as a department representative on project teams. * Communicates deliverables needed, writing process, and timelines to team members. * Understands, assimilates, and interprets sources of information with appropriate guidance/direction from product teams and/or authors. Ensure required documentation is obtained. * Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. * Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. * Confirms completeness of information to be presented. Challenges conclusions when necessary. * Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs. * Arranges and conducts review meetings with the team. * Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate. * Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications. * Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (eg. eDocs, eCTD, journal/congress databases). * Serves as medical writing lead on scientific publications. Works closely with the Publications team(s) on document strategies. * Learns and applies knowledge of therapeutic area and product to scientific publishing projects Education/Experience Required *Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience. * American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical. * 3 yrs relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D. * 3 years experience in experimental design and clinical/preclinical data interpretation preferred. * Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. * Knowledge and experience with Common Technical Document content templates. * Working knowledge of current electronic document management systems and information technology. * Excellent written and oral communication skills. * Ability to assimilate and interpret scientific content and translate information for appropriate audience. * Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy. * Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment. * Experience in working with collaborative, cross-functional teams, including project management experience. Nauticasoft is an equal opportunity employer. We welcome and encourage employee diversity. To learn more please visit us at www.nauticasoft.com
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