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Seattle Genetics Medical Writer II in Bothell, Washington

Seattle GeneticsMedical Writing ยท US Field Based|Bothell, Washington|Seattle, Washington|South San Francisco, CaliforniaDescriptionSummary:The Medical Writer II will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to support other clinical communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.Principal Responsibilities: *Under limited supervision, leads the development and authoring of clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatoryfilings *Under limited supervision, leads the development and authoring of abstracts, posters, slides of clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewedjournals *Provides medical writing support for briefing documents, information requests, nonclinical summaries, and additional documents intended for submission toHAs *Facilitates document review committee meetings and issuesresolution *Provides project teams with guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment indocuments *Organizes, conducts, and leads cross-functional document developmentmeetings *Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statisticaloutputs *Routinely engages clinical research and biostatistics to gain focused understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to variedaudiences *Represents medical writing on study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientificdepartments Required Qualifications: *Minimum of 2 years of experience in the biopharmaceutical industry, with 1 year of direct medical writing experience; advanced degree(s)/academic research/transferable skills may be considered in lieu of industryexperience *BA/BS Preferred Qualifications: *Masters or doctorate degree in life sciences *Excellent written and verbal communication skills with the ability to interpret and present scientificdata *Ability to work cross-functionally *Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat *Awareness of FDA regulations, ICH guidelines, Good Clinical Practices, and the drugdevelopment process *Under limited supervision, able to coordinate and prioritize multiple projects in a fast-pacedenvironment As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.#LI-KO1Apply Here :