Principal Clinical Evaluation Specialist - Shockwave Medical

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Principal Clinical Evaluation Specialist – Shockwave Medical to join our team! This role is fully remote in the United States. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Principal Clinical Evaluation Specialist requires experience in the writing of medical device clinical regulatory documents. The position will mainly focus on development of Clinical Evaluation Reports (CERs) and associated documents including Clinical Evaluation Plans (CEPs), Literature Search Protocols and Reports (LSPs/LSRs) and Post Market Clinical Follow-up (PMCF) Plans and Reports. The main purpose of this job is to author and develop clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance. This job may be expanded to support other clinical evidence documents, including the support of the clinical sections of a PMA/PMAs (US Class III), IDE (US Class II/III), 510K (US Class III), other international medical device applications or other technical writing needs as applicable. Essential Job Functions Authors clinical documentation- mainly the Clinical Evaluation Reports (CER) and supporting ancillary documents (CEPs, LSP, LSR, PMCF) 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 Office of 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. Manages CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools. Interacts with cross-functional teams to define the plan and strategy for development of the CER or other clinical sections for new products requiring CE Mark or International Product Registration. 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., SOP's) 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. 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 Japan 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 Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. Required Skills: Preferred Skills: Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP) The anticipated base pay range for this position is : $125,000.00 - $201,250.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program.