Medical Writer – Remote (Eastern & Central Time Zones) in Wayne, NJ

Medical Writer - Remote (Eastern & Central Time Zones) - Getinge - Wayne, NJ - work from home job Company: Getinge Job description: At Getinge we have the passion to perform Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives. Are you looking for an inspiring career? You just found it. Remote = This role can be 100% remote within the Eastern or Central Time Zones. Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels. We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team. We currently have an opening for a Medical Writer. The Medical Writer is responsible for the generation and development of documents related to clinical documentations and investigations as applicable. Job Responsibilities and Essential Duties • Serves as a clinical evaluation lead and participates within the clinical evaluation team for the development and generation of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR and MDCG guidance. Contribute to the Summary of Safety and Clinical Performance. • Serves as point and participates in the Post-Market Clinical Follow-up (PMCF) team. Specifically contributes to the literature review and the identification and analysis of clinical data related to the PMCF evaluation. • Perform comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required. • Analyze available clinical evidence (data held by the manufacturer, published literature) to evaluate the safety and performance of the subject device under evaluation. • Write and or edit clinical study documentation, including clinical investigational plans/protocols, Investigator's Brochures, Periodic reports, Clinical Investigational Reports/Clinical Study Reports. Ensure high quality study documentation that is submission-ready for various regulatory agency and external distribution. • Contribute to clinical aspects of Technical documentation. Write and/or support the development of manuscripts relating to clinical study data or clinical evidence for submission to peer-reviewed medical journals. Work with medical professionals to ensure alignment with journal requirements for targeted manuscript submission. • Write and/or contribute to abstracts and submissions of clinical data to various medical congresses or symposia. Work with medical professionals to ensure high quality submissions and data integrity. Contribute to the development and optimization of Clinical Affairs SOPs, as needed. • Perform other non-routine duties as assigned by the Supervisor. Required Skills and Abilities • Bachelors, Master's degree or PhD in a relevant scientific discipline, or equivalent. • 1-5 year's medical writing experience. • Direct experience working on clinical evaluations within the Medical Device industry a plus. • Medical writing certification a plus. #LI-DV1 About us Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise 'Passion for Life' close to heart. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world's most respected and trusted MedTec company. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits • 401k plan with company match • Paid Time Off • Wellness initiative & Health Assistance Resources • Life Insurance • Short and Long Term Disability Benefits • Health and Dependent Care Flexible Spending Accounts • Commuter Benefits • Parental and Caregiver Leave • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Expected salary: $90000 - 110000 per year Location: Wayne, NJ Job date: Fri, 25 Aug 2023 01:09:01 GMT Apply for the job now! Apply tot his job