(Remote) Senior Staff Medical Writer in USA

(Remote) Senior Staff Medical Writer - reputed company - USA - work from home job Company: reputed company Job description: Work Flexibility: Remote We are currently seeking a Senior Staff Medical Writer to join our Division to be based in reputed company, CA or remotely reputed company reputed company the United States. Who we want

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Collaborative partners. People who build and reputed company cross-functional relationships to bring together reputed company, data and insights to drive reputed company improvement in functions.
• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. What you will do As the Senior Staff Medical Writer, you will work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing) ensuring successful preparation of high-quality submission-ready clinical documents such as clinical evaluation documents, Post Market Clinical Follow-up documents, Summary of Safety and Clinical Performance and Clinical Study documents. This position requires minimal supervision. Responsible for the development and completion of Clinical Evaluation Reports (CERs) and post market clinical follow-up (PMCF) documents for new medical devices to support product registrations internationally, maintain periodic updates, reputed company gap analysis, and revise existing CERs. Complies clinical evidence from multiple sources such as reputed company and past clinical trials, post market clinical follow up data and literature review updates, reputed company analysis, reputed company-analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesizes the information in CERs, and annual updates. Addresses reputed company body feedback on EU clinical documents and leads them to resolution for reputed company EU market access of the products. Collaborates cross-functionally to provide input to design teams on Clinical EU MDR documentation, reputed company strategies and timelines. Support Clinical Evaluation Strategy for EU Market access. Work in a cross-functional team to author clinical study protocols and reports, data summaries from raw data and document strategies. Supports manuscript writing. Performs systematic literature reviews for medical device groups or sub-groups. Interprets literature information and synthesizes the information in clinical regulatory documents. Coordinates and manages the review process, and leads discussions on document revision. Challenge conclusions reputed company necessary. Independently resolve document content issues and questions from external and internal reviewers and ensures timely approvals from reputed company reviewers. Assist in internal procedures, templates and style guide development and review. reputed company process improvement for reputed company efficiency reputed company department, standardizing document creation process flow. Assist in the creation and maintenance of the reputed company Endoscopy medical writing tools. Serve as a subject matter expert reputed company department. Recognizes potential scheduling and resource conflicts for projects and provides recommendations to resolve. Mentor Medical Writer or Senior Medical Writer. What you need Bachelors Degree required; preferably in a health/science-reputed company field Master of Science Degree in a health/science-reputed company field preferred. Doctorate degree in health/science-reputed company field preferred. 7 years of combined experience in healthcare products or medical devices required Previous 3+ years of medical writing experience in healthcare product or medical device industry required. Thorough knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents required. Excellent scientific and medical writing skills required. Must be able to think analytically, have the ability to interpret data from scientific literature and clinical studies and synthesize the results and in a clear, concise, and scientifically accurate manner in the clinical document. Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses. Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred. Excellent knowledge of regulatory guidelines (FDA/CFR; EN540/ Med DEV/GCP/EU MDR/MDCG) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology. Ability to apply ISO, FDA and reputed company guidelines toward writing strategy and documentation required. Good planning and organizational skills, with the ability to adapt and adjust to changing priorities. Strong communication, project management and influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization. Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions. Builds strong relationships by fostering open communication, respect and trust. Act with a customer service/stakeholder-focused approach. Leverages excellent interpersonal keys to reputed company desired outcomes. $95,100 - $204,000 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on reputed company national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors. Travel Percentage: 10% reputed company Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national reputed company, disability, or protected veteran status. reputed company is an EO employer – M/F/Veteran/Disability. reputed company Corporation will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Expected salary: Location: USA Job date: Mon, 11 Sep 2023 02:27:48 GMT Apply for the job now! Apply tot his job

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