Job Description

Reviews and interprets data (tables, listings, graphs) and source documents (provided or accessed directly from a clinical database) to draft, solicit comments, edit, and finalize an IDE (investigational device exemption) study annual report for FDA. Works with individuals in other functional areas to identify and resolve clinical and statistical issues in the interpretation of clinical data. Conducts literature searches, as appropriate, to provide useful references supporting findings/conclusions in the study report. May also have other writing, proof-reading, or editorial duties related to other clinical deliverables (e.g., clinical overviews, abstracts, manuscripts, etc.). Essential Job Functions Authors clinical documentation - mainly the Clinical Evaluation Reports (CER), including the clinical section of regulatory authority requests for the entire portfolio. Acquires knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to stay current with current literature. Develops comprehensive, systematic literature search protocols, supports in-depth literature searches for CERs and other clinical evidence reports and gains knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies. Responsible for staying informed about applicable clinical landscapes and trends. Provides product guidance to Clinical Affairs, Scientific Affairs, Medical Affairs and other functions (as appropriate) to help with conducting literature searches on products/product families. Reviews literature, interprets and summarizes risks, analyzes alternative therapies and device specific benefits from literature; collects and summarizes primary data to support risk assessment. Critically appraises scientific literature and writes clinical summaries for products and procedures. Responsible for proofreading, editing, formatting, and reviewing comment integration and document completion/approval activities. Performs periodic reviews of risk documentation and product labeling; ensures appropriate updates are implemented. Provides clinical perspective and support to guide new product development for CE Mark/International product registration purposes. Authors protocols and/or routine clinical study progress reports. Ensures compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines). May support other medical writing/scientific communication efforts (I.e. peer-reviewed publication, white paper, podium presentation) as requested. Other duties as required. Duties and Responsibilities Reviews and interprets data (tables, listings, graphs) and source documents (provided or accessed directly from a clinical database) to draft, solicit comments, edit, and finalize an IDE (investigational device exemption) study annual report for FDA. Works with individuals in other functional areas to identify and resolve clinical and statistical issues in the interpretation of clinical data. Conducts literature searches, as appropriate, to provide useful references supporting findings/conclusions in the study report. May also have other writing, proof-reading, or editorial duties related to other clinical deliverables (e.g., clinical overviews, abstracts, manuscripts, etc.). Desired Skills and Experience Requirements: Bachelor's degree in a scientific or engineering field of study 10 years of experience in medical devices with at least 5 years of direct experience in CER writing Expertise in medical device applicable regulations including but not limited to, MEDDEV 2.7.1, MDR, PMA, 510K, IDE and China (NMPA) Experience in the application of therapeutic and device knowledge to develop CERs Strong experience in conducting literature searches, reviews and appraisal of scientific data Strong experience in protocol development, writing clinical section for regulatory submission and clinical evaluation report writing Ability to identify critical information needs and identify stakeholders within clinical evaluation assessment and report development Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills Excellent critical and analytical thinking skills Must have a high level of attention to detail, accuracy and organization Must be able to work effectively on cross‑functional teams Must be able to manage multiple projects across various disciplines Strong communication, presentation and interpersonal skills EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #J-18808-Ljbffr

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