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Becton Dickinson
As a Deputy Manager, Medical Writing you will be responsible for the evaluation of clinical data and in the writing/creation of clinical evaluation plans and reports. These documents are used in regulatory submissions to support safety and performance of our products, to help define clinical endpoints for currently marketed devices and New Product Development Teams, and to aid in the identification of new risks, indications and unmet needs. This role will support the BD Medication Delivery Systems Unit - Medical Affairs Function. This individual will report to the Associate Director, Medical Affairs within this team. If you would like to part of a talented and dynamic team and love working on challenging projects, come join the BD family!
Essential Duties and Position Responsibilities
Independently prepares, writes, and edits documents to support global regulatory submissions and associated communications with regulatory authorities. The primary focus is independent writing of Clinical Evaluation Plans and Reports (CEP/CERs) and associated documentation, such as Subject Device, Similar Device(s), and State of the Art literature reviews per the European Union (EU) Medical Device Regulation (MDR). Works with cross functional teams such as Business Unit Medical Affairs, Regulatory Affairs, R&D, Post-Market Surveillance (PMS), Quality, and Marketing to create new or update existing CEPs and CERs. Additional activities may include literature searches to support additional business needs, and writing of clinical study manuscripts . Responsible for critically analyzing and interpreting clinical data (e.g., literature, real world data, clinical trials, etc.) and writing a thorough and accurate analysis of such data in the clinical evaluation documents. Ensures documents are produced in accordance with corporate/ business unit procedures, regulations/ guidance, and medical writing templates and style guides.
Qualifications, Knowledge, and Skills Required:
Bachelor’s Degree in the sciences with 3+ years of experience in the medical device/ pharmaceutical industry and clinical, scientific, or literature research experience required. Advanced degree in a scientific discipline preferred (e.g., PhD, PharmD, MPH/MSPH, etc.).
Published work is a plus. At least 3 years of experience writing Clinical Evaluation Reports (CERs) beginning to end is required (5 years or more preferred). Ability to evaluate complex clinical data sets and write clear, evidence-based summaries about safety and performance of medical devices with impeccable accuracy. Excellent English Language communication skills. Exceptional writing skills, strong grasp of medical terminology and grammar, and ability to quickly learn and write about varied therapeutic areas. Highly skilled in Microsoft Word, Excel, Outlook, and PowerPoint. Thorough knowledge of medical device regulations and guidance, including EU MDR, MEDDEV 2.7/1 Rev 4, MDCG, and IMDRF required. Experience with Class I, Class II, and high risk(Class III) medical devices preferred. Working knowledge of clinical literature review, clinical research, device development, regulatory requirements, good clinical and data management practices, and scientific or clinical research and methods. Demonstrated expertise conducting literature searches using OVID Embase, PubMed, Medline, or other similar medical literature databases. Demonstrated ability to meet project goals within a matrixed environment. Must be able to handle a variety of projects at the same time and complete deliverables on time. Demonstrated ability to communicate and collaborate in a remote team environment, and also to work independently with minimal supervision
