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Medical Writing Associate I

Company: Altasciences Preclinical Seattle, LLC
Location: Everett
Posted on: November 18, 2020

Job Description:

Medical Writing Associate I Everett, WA, USA Kansas, USA Ontario, Canada Overland Park, KS, USA Pennsylvania, USA Philadelphia, PA, USA Virtual Req 1219 Thursday, November 12, 2020 Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Kansas City, KS, Seattle, WA and Philadelphia, PA. Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster. The Medical Writing Associate I is responsible for providing highquality documents to support sponsors' research programs. Responsibilities; Develop, amend and revise informed consent forms and protocols and any other supporting documents for studies of simple to moderate complexity; Work closely with team members to handle client/institutional review board (IRB) comments; Assist in entry of protocol-related information into the computer management system required for clinical conduct, as required; May prepare protocol-derived sections of clinical study reports (CSRs), compile and review CSR appendices in accordance with project/client specifications and International Conference on Harmonisation (ICH) E3 guidance; Preparation and writing of Food and Drug Administration (FDA) summary tables, Health Canada Comprehensive Summary- Bioequivalence, safety reports, and other regulatory documents as needed; Perform quality control (QC) of documents prepared by other team members; May participate in the accurate classification of events and medications using standardized coding systems for studies of simple to moderate complexity; Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines; Conduct all work in compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and all regulatory guidelines; Maintain familiarity with client expectations and produce documents consistent with these; Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], FDA, European Medicines Agency [EMA], etc) as well as ICH and GCP procedures; May participate in departmental or interdepartmental quality improvement initiatives; Maintain and participate in the objectives of the department; Other duties as assigned. Profile desired; Bachelor's Degree in health-related sciences or relevant field and/or relevant professional experience; Excellent verbal and written communication skills in French and in English; Professional attitude and strong interpersonal skills; Ability to work well with a multi-disciplinary team of professionals; Client-focused approach to work; Flexible attitude with respect to work assignments and new learning; Ability to prioritize workload; Superior attention to detail; Understanding of clinical research, drug development process, and applicable regulatory guidelines; Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems. Altasciences uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.E-Verify.gov. Everett, WA, USA Kansas, USA Ontario, Canada Overland Park, KS, USA Pennsylvania, USA Philadelphia, PA, USA Virtual Share this job: Altasciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

Keywords: Altasciences Preclinical Seattle, LLC, Everett , Medical Writing Associate I, Other , Everett, Washington

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