BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all.
In this role, you will write and edit clinical and scientific reports including summaries from raw data for submission to regulatory agencies for in-company use, comprehensive literature reviews, exhibits and other projects requiring skills in medical communication. In addition, you will coordinate and complete the writing of Clinical Evaluation Reports (CER) to provide clinical evidence that supports the safety and effectiveness of Surgery products (pre-market and post market).
Preparing, writing, editing and reviewing regulatory documents and responses to regulatory authorities (notified bodies, FDA). Efforts will center on Clinical Evaluation Reports and clinical data reports/summaries in support of PPA and VM products.
Conducting search of peer-reviewed databases to identify pertinent published literature.
Working with new product development teams and RA specialists to create new and updating existing CERs. This includes critical review and incorporation of data from published, unpublished and historical clinical
Participating in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screen articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups and sub-groups.
Organizing and incorporating information, such as references, graphics, tables, and data listings for the creation of large technical documents.
Coordinating with various departments (Regulatory, Product Development, Clinical Affairs, Preclinical, R&D, and Quality) to access and identify the necessary pre-clinical, clinical and technical information.
BS in Biomedical Engineering or Biological Sciences; MS is preferred.
5 years’ experience in Regulatory Affairs or Medical writing, experienced in information technology (literature searching).
Ability to demonstrate exceptional writing skills is required.
Experience in endnote and/or Distiller is a plus.
RAC OR AMWA certifications are also a plus.
We offer a competitive salary and comprehensive benefits package. For immediate consideration, please apply online at: