Scientist Sr, Clinical (Medical Writer)
Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT
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Scientist Sr, Clinical (Medical Writer) 9837BR Title: Scientist Sr, Clinical (Medical Writer) Job Description: INNOVATION STARTS WITH YOU Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We’re a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention TERUMO has to offer. Open to REMOTE workers. The Sr. Clinical Scientist provides scientific expertise for developing clinical evaluations, risk management, and /or clinical studies. The successful candidate writes/manages clinical evaluation reports or clinical trial protocols clinical trial registrations and results postings and scientific publications. The Sr. Clinical Scientist position will drive scientific activities associated with the design, conduct and reporting of clinical trials for assigned therapeutic areas, interfacing with the Medical Affairs, Regulatory, Clinical Research, R & D, and Marketing departments. Typical duties might include: + Provide scientific support to justify trial design and ongoing scientific analysis during protocol development, including generation of pre-protocol documentation of scientific information. + Lead the generation of study-related documents and/or contribute content and oversight of such documents including clinical study protocols, reports of priors, investigatory brochures, and case report forms. + Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area. + Responsible for updating medical affairs procedural documents and submitting change requests when needed. + Generate documents to support regulatory submissions and/or respond to questions from regulatory authorities about existing submissions. + Review and critically analyze clinical data and statistical analysis plans. + Participation in scientific report writing. Presentation of methods, results and conclusions to a publishable standard. Lead study level publication planning. + Support the generation of white and position papers by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice. + Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts. + Contribute to the optimization of internal processes and workflows. + Assist the medical director with direct customer interactions as needed. Auto req ID: 9837BR Location: Aliso Viejo, California, USA Department Name: 527-Medical Affairs Qualifications: 1. Must have a Master’s degree in a relevant science, medicine, or similar discipline. 2. Must have at least three (3) years of relevant clinical research scientist experience. 3. Knowledge of Good Clinical Practices (GCP) is required. 4. Excellent writing and editing skills, and a keen attention to detail. 5. Strong verbal, written, and interpersonal communication skills. 6. Clinical protocol development experience. 7. Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases. 8. Proven analytical skills working with clinical or research data. Desired Qualifications 1. PhD with a minimum of one (1) year experience in clinical research 2. Experience as author or contributor or peer-reviewed manuscripts is strongly desired. 3. Knowledge of patient safety, quality, clinical research, strategic planning, health bio-statistics or epidemiology is desired. 4. Experience interacting with FDA or China regulatory agencies highly preferred. External-Facing Title: Sr. Clinical Scientist (Medical Writers) Posting Country: US – United States We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.