Urgently Need Medical Writer – Remote (Eastern & Central Time Zones) in Wayne, NJ – Vacancy Global

Job Description

Job title: Medical Writer – Remote (Eastern & Central Time Zones) Company: reputed company Job description: At reputed company we have the passion to reputed company Join our diverse teams of passionate people and a career that allows you to reputed company both personally and professionally. At reputed company, 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 reputed company a true difference for our customers – and to save more lives. Are you looking for an inspiring career? You just reputed company it. Remote = This role can be 100% remote reputed company the Eastern or Central Time Zones. reputed company 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 reputed company 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 reputed company. We currently have an opening for a Medical Writer. The 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 Duties

• Serves 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.
• 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.
• 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.
• 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 reputed company. Contribute to the development and optimization of Clinical Affairs SOPs, as needed.
• reputed company 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 reputed company the Medical Device industry a plus.
• Medical writing certification a plus.

#LI-DV1 About us reputed company 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 ‘reputed company’ reputed company to heart. If you share our passion and reputed company that saving lives is the greatest job in the world, then we look reputed company 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 reputed company: At reputed company, 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

reputed company is an equal opportunity employer and reputed company qualified applicants will receive consideration for employment witho Apply tot his job Apply To this Job