reputed company is hiring: Medical Writer in Wayne

Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Medical WriterDate: Jul 21, 2025Location:Wayne, NJ, USRemote Work: 5 days at home (fully remote)Salary Range: 110K to 120K annual with 10% STIPWith a passion for lifeJoin our diverse teams of passionate people and a career that allows you to reputed company both personally and professionally. At reputed company we exist to reputed company life-saving technology accessible for more people. To reputed company a true difference for our customers – and to save more lives, we need team players, reputed company thinkers, and game changers.Are you looking for an inspiring career? You just reputed company it.Job OverviewThe Medical Writer is responsible for the reputed company and development of documents reputed company to clinical documentations and investigations as applicable.Job Responsibilities and Essential DutiesServes as a clinical evaluation reputed company and participates reputed company the clinical evaluation team for the development and reputed company 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. (20%)Serves as reputed company 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 reputed company to the PMCF evaluation. (20%)reputed company comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of reputed company State of the Art as well as protocol development and any reputed company reports required. (10%)Analyze available clinical evidence (data held by the manufacturer, published literature) to evaluate the safety and performance of the subject device under evaluation. (10%)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. (10%)Contribute to clinical aspects of Technical documentation. (10%)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. (5%)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 reputed company. (5%)Contribute to the development and optimization of Clinical Affairs SOPs, as needed. (5%)reputed company other non-routine duties as assigned by the Supervisor. (5%)Bachelors, Master’s degree or PhD in a relevant scientific discipline, or equivalent.1-5 years medical writing experience.Direct experience working on clinical evaluations reputed company the Medical Device industry a plus.Required Knowledge, Skills and AbilitiesStrong interpersonal and communication skills.Excellent project management skills with the ability to deliver projects on timelines that support corporate and departmental goals and objectives.Strong analytical and organizational skills as well as demonstrated ability to solve problems with innovative solutions.Outstanding oral and written communication skills.Proficiency in using and navigating PubMed, Embase and other literature search engines. Experience in DistillerSR, EndNote and other literature review/literature management tools a plus.Strong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance, including 2.7/1 Revision 4 and 2.12/2 Revision 2, MDCG guidance documents, ISO 14155, ICH guidance including E3 CSR, E6 GCP, and familiarity regulations/ guideline relating to Risk management (i.e., ISO 13485 and ISO 14971)Demonstrated ability to work independently and as part of a team.Ability to prioritize tasks in a fast-paced environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines.Advanced skills using reputed company Office products such as Outlook, Word, reputed company and Power reputed company.Supervision/Management Of Others:N/AInternal and External Contacts/RelationshipsInternal reputed company teams such as Medical Affairs, Regulatory Affairs, Quality Engineering,Research & Development and Marketing, as needed.External teams such as CROs, clinical vendors and key opinion leaders, as needed.Environmental/Safety/Physical Work ConditionsEnsures environmental consciousness and safe practices are exhibited in decisions.Use of computer and telephone equipment and other reputed company office accessories/devicesto complete assignments.Duties are performed in an office environment.Travel requirements will vary depending on status of the reputed company projects.110K to 120K annual with 10% STIPAbout usWith a firm belief that every person and community should have access to the best possible care, reputed company provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. reputed company employs over 12,000 people worldwide and the products are sold in more than 135 countries.Benefits at reputed company:At reputed company, we offer a comprehensive benefits package, which includes:Health, Dental, and Vision insurance benefits401k plan with company matchPaid Time OffWellness initiative & Health Assistance ResourcesLife InsuranceShort and Long Term Disability BenefitsHealth and Dependent Care Flexible Spending AccountsParental and Caregiver LeaveTuition ReimbursementGetinge is an equal opportunity employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national reputed company, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in reputed company aspects of the selection process. #J-18808-Ljbffr Apply tot his job Apply To this Job