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Apex Systems, Inc Remote Senior Medical Writer (1117868) in Overland Park, Kansas

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/ada/r/jobs/11386108 Apex Systems is seeking a Senior Medical Writer to work remotely for our large healthcare Client and must be based in the U.S.For immediate consideration, please email Nick, at nkreutz@apexsystems.com.Role: Senior Medical WriterWork Location (address): remote, US-basedEstimated Duration (in months): 6-12 monthsTotal Weekly Hours: 20-40 hoursJob Description:Responsibilities and Expectations Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically-oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, agency RTQs, and eCTD summary documents for IND, NDA, MAA, BLA and biosimilar BLA applications and amendments. Interpret data, search and analyze published literature, define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions. Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner. Manage and direct client project teams, including identifying, directing, and delegating tasks necessary for successful document completion. Interact directly with clients and contractors; participate in and lead discussions during meetings. Collaborate with project teams to respond to heath authority questions and requests. Collaborate and help other medical writers in the writing, editing, QC review and compilation of documents. Prepare and manage project plans and timelines. Organize/prioritize work with limited guidance and manage projects in a timely and effective manner; work on multiple projects simultaneously and reorganize and reschedule work as needed in order to meet client deadlines. Understand and support the nature of our business and our company's commitment to quality and responsiveness. Proactively develop/maintain technical knowledge, remain up-to-date on current trends and best practices; leverage expertise to produce solutions that enable global consistency and standardization to ensure exceptional performance.Skills required:Qualifications PhD, PharmD, MS, BS, RN, or RPh in a relevant scientific or pharmaceutical discipline. 10 years (minimum) of experience in pharmaceutical industry with 6 years (minimum) of experience in medical/regulatory writing.. Experience with biosimilars and BLAs preferred. Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding of medical terminology and statistical methodology is a must. Must have experience writing:1 - clinical protocol synopses,2 - clinical protocols,3 - Investigator Brochures,4 - clinical study reports,5 - eCTD clinical summaries for INDs,6 - eCTD clinical summaries for NDAs and BLAs, including integrated summaries of safety and efficacy. Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as edit on all levels, from copy editing to major rewriting. Experience and proficiency with document templates and proper version control. Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail.EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, an cestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available http://www1.eeoc.gov/employers/upload/eeoc\_self\_print\_poster.pdf