Quality Review Specialist - Anywhere, US Office Based or Remote Based Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of \"Bringing Clinical Trials to Life,\" we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The Quality Review Specialist is responsible for thorough reviewing the documents written within or outside of the Company in order to ensure a standard of that meets or exceeds our client's expectations. Specific tasks would include: Review of documents that include, but are not limited to, clinical student reports, serious adverse event narratives, study protocols, investigator's brochures, development safety update reports, regulatory submissions (sections of INDs, CTDs, NDAs, BLAs), and publications (abstracts, manuscripts). Responsible for ensuring the accurate transfer of the data and other information from multiple sources into the completed document in a timely and cost-effective manner and meeting the client, the Company, and regulatory requirements and specifications. Brings together knowledge of medicine, clinical research, experimental design, English grammar, regulatory requirements, and Company procedures to complete a review. Bachelor's degree in a science, Masters preferred 4 years of relevant scientific experience including 2 year of experience within the pharmaceutical/medical device industry and 2 years of writing, clinical research, and editing experience, 2 years of experience collecting data and analyzing it. Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Qualifications: Has an excellent working knowledge of medical and pharmaceutical terminology, clinical research and statistical concepts, and guidelines and requirements of US and international regulatory agencies Has excellent analytical skills Has excellent problem-solving capabilities and organizational skills and effective interpersonal skills Possesses excellent grammatical and exceptional oral and written communication skills Has excellent editorial/proofreading skills and basic understanding of the reviewing and editing processes Is knowledgeable about the methods, techniques, and procedures of medical writing Is thorough, with an attention to details, and methodical Is adaptable to changes in work duties, responsibilities, and requirements Can appropriately judge the need for changes Is able to concentrate on the details in a document without losing sight of the document as a whole Can perform numerous simple and complex tasks without ignoring the overall objectives Can independently determine the need to develop methods, techniques, and evaluation criteria to obtain results Proficiency in Microsoft Word, Excel, and PowerPoint, Outlook. Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations. If you're passionate about bringing clinical trials to life, we encourage you to apply today! Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.
Associated topics: aseptic, biopharma, diet, dietetic, disease, food scientist, histologist, nutritionist, pharmacometrics, transfection
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.