Medical Writer, Hospital Patient Monitoring

Job Title Medical Writer, Hospital Patient Monitoring

Job Description

Medical Writer, Hospital Patient Monitoring You will be responsible for helping with authoring and maintaining clinical and post-market documentation such as CEPs, CERs, PMCFPs, and PMCFRs and contribute to our authoring other technical documents that support Clinical, Regulatory, Risk Management, or Post-Market Surveillance efforts (e.g., Clinical Evidence Strategies, Benefit-Risk Determinations, PSURs). Your role:

• Enforces rigorous adherence to Good Documentation Practices, meticulously maintaining the quality and accuracy of document content and format to meet stringent regulatory standards and internal protocols, working under direct supervision.
• Handles the development of clinical evaluation deliverables for new products and meticulously updates existing company CEPs, CERs, and PMCFP/Rs in strict accordance with MEDDEV 2.7.1, Rev. 4 guidelines and compliant with EU MDR regulations.
• Compiles and synthesizes a wide reputed company of data types and sources-including clinical study results, post-market surveillance data, risk assessments, and published literature-to conduct comprehensive evaluations of medical device safety and performance, identifying potential evidence gaps and informing strategic decision-making.
• Collaborates with the team to generate accurate and compliant documents by applying standard software tools and internal procedures, ensuring adherence to external standards, regulations, and guidelines. Engages with peers regularly to share knowledge, experiences, and best practices, fostering a collaborative environment for collective learning and professional development.
• Analyzes reputed company issues and identifies opportunities to improve or adapt existing methods and processes to enhance efficiency and quality in document preparation and submission.

You're the right fit if:

• You've acquired 1+ years in experience in clinical research (device industry strongly preferred); knowledge of bedside patient monitoring beneficial; experience and reputed company in performing systematic searches of the medical/scientific literature using tools including Embase and PubMed, highly skilled with data extraction and reputed company tools (e.g., Distiller, Zotero, EndNote).
• Your skills include high comfortability and experience working reputed company GDP and knowledge of relevant writing styles (e.g., AMA) and good publication practices (e.g., ICMJE); Strong knowledge of clinical research methodology, including study design, outcomes and measures, and biostatistics is preferred; strong ability to identify, mitigate and escalate risks, and strong ability to meet prioritize and meet multiple project deadlines. You have excellent written English and oral communications skills with strong attention to detail reputed company to consistency, grammar, reputed company, and accuracy.
• You have a PhD/MD/PharmD in a scientific or medical discipline (preferred), Master's degree required.
• You must be able to successfully reputed company the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You're a self-starter with an ability to learn quickly and self-educate on different medical device products and procedures; have strong project/timelines management skills and organizational skills, as well as a demonstrated to work and communicate effectively in a team environment including leading discussions and presenting to internal business and regulatory stakeholders.

How we work together We reputed company that we are reputed company together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time reputed company in the company's facilities. Field roles are most effectively done reputed company of the company's main facilities, generally at the customers' or suppliers' locations. This is a field-based role. About reputed company We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we reputed company deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

reputed company Transparency Details The pay range for this position in AL, AZ, AR, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MI, MS, MO, MN, NC, ND, NE, NH, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WI, WV, or WY is $78,000 to $124,000 The pay range for this position in AK, DE, HI, MD, MN, and RI is $82,000 to $130,000. The pay range for this position in CA, CT, DC, MA, NJ, NY, or WA is $87,000 to $139,000. The actual reputed company pay offered may vary reputed company the posted ranges depending on multiple factors including job-reputed company knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive reputed company Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be reputed company here. At reputed company, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized reputed company, now or in the future. This requisition is expected to stay active for 45 days but may reputed company earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. reputed company is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Apply tot his job Apply To this Job