Technical Writer/Clinical Evaluation Report Lead
The Technical Writer/Clinical Evaluation Report Lead is responsible for the planning and execution of systematic literature reviews, Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEPs) and Post-Market Clinical Reports (PMCRs) for assigned therapeutic area and projects. May also participate in planning/writing of other general medical writing activities including other clinical research documents as needed (e.g. clinical study reports).
POSITION DUTIES & RESPONSIBILITIES:
Responsible for the planning and execution of clinical documents related to EU regulatory compliance for assigned therapeutic area and projects including systematic literature reviews, clinical evaluation plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Reports (PMCRs) and other clinical documents as needed (e.g. new clinical documents related to the upcoming 2020 EU MDR regulations).
Collects and compiles available clinical evidence for CER updates (clinical study outcomes, post-market surveillance data, PMCF updates, etc.) and completion of post-market clinical reports (PMCRs) for product surveillance
Ensures CER and CEP documents include references to the appropriate quality system and regulatory documents (e.g. risk management documents, PMS, etc.) to make certain information is consistent; manages communication with cross functional business partners to ensure appropriate information is obtained and referenced.
Assists in the development of schedules to ensure CER and PMCR timelines are met
Ensures maintenance of CERs/CEPs and CER/CEP updates in a document control management system (e.g. Agile).
Leads/oversees literature search process (generating literature search protocols, reviewing/appraising results obtained, summarizing/analyzing pertinent clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation
Communicates with other writers, clinical scientists, clinical study managers, engineers, project managers, regulatory associates, product safety, etc. to ensure clinical and technical content appropriately incorporated.
Oversees/reviews document drafts from Medical Writers as appropriate; works directly with Medical Writers to ensure timely completion of clinical documents.
Completes document formatting and layout as necessary.
Utilizes software to support the core process steps for systematic literature reviews (e.g. Distiller)
Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports.
Organizes clinical data from literature into references, graphics, tables, and data listings
Understands, interprets and summarizes complex results from the scientific literature including statistical results of clinical studies; presents results in a clear, concise and scientifically accurate manner for various end users (e.g. regulatory bodies, etc.)
Incorporates text, tables, graphs, charts, statistical analyses, etc. into clinical documents in a clear and accurate manner with proper formatting.
Works in a team with other clinical research personnel and external medical writers for generation of clinical documents; may oversee external vendor contractors/work.
Prepares other clinical research documents containing clinical and technical data in support of JJV’s medical device product lines as needed (e.g. clinical study reports).
o Includes tracking and maintaining raw data tables/listings from biostatistics, drafting text, formatting tables, compiling final documents.
Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7/1) and electronic templates.
Supports and at times may act as an SME during audits and inspections pertaining to CER/PMCR processes and reports
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Maintains compliance with state, federal and international regulations.
EDUCATION & EXPERIENCE REQUIREMENTS:
BA, BS, or BSN is required; advanced degree is preferred
Two (2+) years of related job experience in medical or scientific writing; advanced degree (M.S. or higher) may be acceptable.
Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is required
Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, product development processes, medical device risk management processes and common biostatistical methods is preferred
Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines
Skilled in narrative or systematic literature reviews (e.g. PRISMA, Cochrane) preferred
Experience using software systems to manage literature data (e.g. Distiller) preferred Able to quickly develop therapeutic expertise across medical device portfolios, business objectives, clinical data/evidence
Strong oral communication, presentation, project management and prioritization skills
Excellent interpersonal relationships
Highly proficient in Microsoft Office Suite (MS WORD in particular) and bibliographic software (e.g. Endnote, Reference Manager)