Job Closed
This listing is no longer active.
As a leading full-service global CRO, we work to create solutions that advance new treatments from discovery to reality.
Senior Medical Writer
Location
Northern America + 1 moreAll locations: Northern America | Europe
Posted
17 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Senior Medical Writer
Worldwide Clinical Trials
Role Description Prepare and lead the medical writing team on Phase I-IV study documents such as: - Protocols and protocol amendments - Informed consent documents and assents - Complete clinical trial reports (CTRs) - CTR narratives - Investigator Brochures - Other study-related documents in accordance with regulatory requirements (USA, Europe and/or ROW) and WCT SOPs Prepare and lead the medical writing team on Phase I-IV study documents applicable in regions outside of the USA, including but not limited to: - IMPDs - Protocol Lay Summaries - CTR Lay Summaries - Assents Work with other departments in Worldwide preparing and leading the development of: - Pre-IND documents - Synopsis - Briefing books for all authorities (FDA, EMA, MHRA, Health Canada etc.) - Updating all documents following agency feedback Responsible for key documents template management in accordance with global regulations. Serve as publishing point-of-contact in conjunction with the Publisher for CTRs or other documents, as needed. Qualifications - Excellent written and spoken English - Ability to accurately interpret data and express findings in a clear and concise written manner - Excellent project/time management and organizational skills, and ability to work independently - Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects - Comprehensive Microsoft Office skills, especially Word, but also PowerPoint, Excel, and Outlook - Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9) Requirements - University/college degree (life science or related allied health profession) or equivalent combination of education and experience - Minimum of 4 years of experience as a Medical Writer or equivalent role as determined by management Benefits - Opportunity for ongoing training and career development
Related Guides
Related Categories
Related Job Pages
More Medical writer Jobs
Clinical Documentation Improvement Specialist
UnitedHealth GroupUnitedHealth Group is a healthcare and well-being company that’s dedicated to improving the health outcomes of millions around the world. We are comprised of
Role Description Jobs in this function provide coding and coding auditing services directly to providers. This includes the analysis and translation of medical and clinical diagnoses, procedures, injuries, or illnesses into designated numerical codes. Employees in jobs labeled with ‘SCA’ must support a government Service Contract Act (SCA) agreement. You’ll enjoy the flexibility to work remotely from anywhere within the U.S. as you take on some tough challenges. Primary Responsibilities: - Provides expert level review of clinical records within 24-48 hours of admission; reviews clinical documentation to ensure consistency and alignment with evidence-based guidelines. - Conducts clear communication to providers to reinforce evidence-based guidelines are being followed. - Effectively tracks productivity to allow for accurate/timely reporting of leading indicators and future impact analyses. - Provides expert level leadership for overall improvement in clinical documentation by providing proficient level review and assessment, and effectively articulating recommendations for improvement, and the rationale for the recommendations. - Provides educational opportunities for physicians and other health care team members. - Provides complete follow through on all requests for clarification or recommendations for improvement. - Participates in the development and execution of education strategies resulting in improved clinical documentation. - Provides timely feedback to providers regarding clinical documentation opportunities for improvement and successes. - Engages and consults with Medical Director/leadership when needed, per the escalation process, to resolve issues regarding answering clarifications and participation in the clinical documentation improvement process. - Actively engages with Care Coordination and the Quality Management teams to continually evaluate and spearhead clinical documentation improvement opportunities. - Generally work is self-directed and not prescribed. - Works with less structured, more complex issues. - Serves as a resource to others. Qualifications - Undergraduate degree or equivalent experience. - Current RN License or Medical School Graduate. - For RN: 3+ years acute inpatient CDI experience. - For Medical School Graduates: 2+ years of acute inpatient CDI experience. - Experience communicating & working closely with Physicians. - Basic proficiency using a PC in a Windows environment, including Microsoft Word, Excel, and Electronic Medical Records. Requirements - If RN, BSN degree. - Current certification as a CCDS, CDIP or CCS. - Excellent verbal and written skills including solid organizational skills. Benefits - Comprehensive benefits package. - Incentive and recognition programs. - Equity stock purchase. - 401k contribution (all benefits are subject to eligibility requirements).
Medical Writer
OrthofixOrthofix transforms patient lives worldwide through medical technologies that heal musculoskeletal pathologies.
Role Description At Orthofix, we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. We seek team members who build relationships, share knowledge, challenge the status quo, and deliver results to help us achieve our vision to be the unrivaled partner in Med Tech. Job Duties: - Review medical scientific literature, analyze clinical risk and provide benefit/risk assessments. - Write, review, and edit Clinical Evaluation Reports (CERs) to comply with international regulations. - Write and update coherent and convincing CERs and Post-Market Clinical Follow-up (PMCF) Reports by organizing and evaluating large amounts of scientific/clinical/medical data. - Prepare and update Summary of Safety and Clinical Performance (SSCPs) according to the SOP, based on the CER and other sources, including the part for lay persons. - Write and update Clinical Evaluation Plans (CEPs) and PMCF plans. - Work collaboratively with cross-functional partners. - Prepare answers to Notified Body or Regulatory Agency requests. - Assist with other clinical, marketing, and regulatory projects as assigned (including preparation of Instructions for Use (IFU) and Periodic Safety Update Reports (PSUR)). - Acquire, interpret, analyze, and draw conclusions from clinical data from clinical trials, literature, and experiences for a wide variety of medical devices. - Communicate scientific content in a clear and concise manner. - Mentor and train new incoming team members about procedures and best practices. - Perform other duties as assigned. Telecommuting permitted from anywhere in the U.S. Qualifications - PhD degree in Biomedical Engineering or related field. - 1 year of experience writing and developing clinical documentation. - Experience planning and developing clinical evaluation reports (CERs), clinical evaluation plans (CEPs), and summary of safety and clinical performance reports (SSCPs). - Experience working on clinical documents for global product registrations and continued market access. - Experience conducting systematic literature searches in PubMed, EMBASE, or other relevant platforms. - Experience using citation management software. Requirements - PhD degree in Biomedical Engineering or related field. - 1 year of relevant experience. Job Location Lewisville, TX (Telecommuting permitted from anywhere in the U.S.) Disclaimer The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status. Equal Employment Opportunity We are committed to providing equal employment opportunities to all employees and applicants without regard to protected status in accordance with all applicable federal, state, and local laws.
Clinical Documentation Integrity Nurse – Data Analytics
Baptist Health System KY & INTo demonstrate the love of Christ by providing and coordinating care and improving health in our communities.
• Responsible for CDI query reconciliation accuracy • Compiling and generating key performance metrics for entities such as physicians, providers, CDI team and facility leadership after review with CDI Leadership • Participate on multi-disciplinary enterprise quality and process improvement teams • Collaborate with CDI Auditor/Educators to develop and implement programs for ongoing CDI, physicians, providers, and ancillary departmental education • Evaluate opportunities for new CDI initiatives via ongoing metric analysis including validating workflows, tracking, and trending of results • Perform other duties as assigned
Clinical Documentation Specialist RN
Johns Hopkins Medical Management CorporationJohns Hopkins Intrastaff is the internal staffing agency for the Johns Hopkins Health System and partner hospitals, providing temporary support to a variety of the Johns Hopkins locations. Our employees are the strength of our service. Intrastaff is unique because it's one of the very few agencies where a person has the benefit of being a temporary employee and also feels like a member of a large organization. Working at Hopkins means joining a culturally diverse team that includes some of the best nurses, physicians, and allied health professionals in the world. Directly or indirectly, you'll have exposure to cutting-edge technology and groundbreaking medical research.
Role Description The Clinical Documentation Specialist (CDS) is responsible for: - Distributing documentation information to respective departments. - Performing educational outreach to individual units and provider groups. - Supporting training of new staff members. - Designing and developing educational tools for staff and Providers. - Facilitating improvement in the overall quality and completeness of concurrent medical record documentation. - Helping achieve accurate inpatient coding, APR-DRG assignment, severity level, and reimbursement. - Functioning as subject matter liaison and leading documentation improvement initiatives. - Serving on internal hospital committees. - Obtaining appropriate documentation through interactions with physicians and collaboration with other departments. - Additional responsibilities as assigned. Shift/hours: Mon – Fri, 8:00am-5:00pm EST Location: 100% Remote (EST hours) Payrate: $60 hourly Qualifications - Baccalaureate degree, or associates degree, or diploma in nursing from an accredited school of Nursing OR successful completion of an AMA approved Physician Assistant program OR successful completion of the academic requirements of Health Information Technician (RHIT) or Registered Health Information Administrator (RHIA) certification accredited by CAHIIM. - Active RN License. - EPIC experience. - 12 months current RN experience in a similar role in MD or nationally using MSDRG. - Medicare Coding regulations 2024. - Minimum of 3 years Registered Nurse clinical experience in a similarly complex acute care setting. - Minimum of 2 years as a Clinical Documentation Specialist required. - In lieu of complex acute care experience, a minimum of 3 years of CDI experience and/or other relevant clinical experience may be considered. Requirements - Comprehensive knowledge of anatomy, physiology, and all body systems. - Strong background knowledge of disease processes and pharmacology. - College-level knowledge of Medical Terminology. - Complete understanding of the unique functions of each clinical area. - In-depth knowledge of clinical coding processing and documentation standards, guidelines, policies, and procedures. - Conversant in clinical documentation improvement. - High level of proficiency in adult education and training. - Thorough understanding of Hospital bylaws and Joint Commission standards. - Proficiency in abstraction and data entry into all database systems used for clinical documentation. - Ability to read and interpret electronic and manual documentation generated by healthcare professionals. - Understanding of HSCRC, Maryland Quality Improvement Programs, and CMI impact on hospital budget. - Knowledge of Healthcare Insurance Portability and Accountability Act (HIPAA). Skills - Conversant in ICD-10-CM, APRDRGs, DRGs. - Strong interpersonal and communication skills (verbal, non-verbal, and listening). - Understanding of adult learning theory, instructional design, and critical thinking. - Competent level with Microsoft Office Suite, web-browsers, email, electronic health records, online collaboration software, and virtual meeting applications. - Ability to work in a dynamic, team-oriented environment. - Ability to work independently and be self-directed. - Ability to work under pressure to meet submission, project, and reporting deadlines. - Ability to work in a fast-paced academic teaching hospital. Company Description Johns Hopkins Intrastaff is the internal staffing agency for the Johns Hopkins Health System and partner hospitals, providing temporary support to a variety of the Johns Hopkins locations. Our employees are the strength of our service. Intrastaff is unique because it's one of the very few agencies where a person has the benefit of being a temporary employee and also feels like a member of a large organization. Working at Hopkins means joining a culturally diverse team that includes some of the best nurses, physicians, and allied health professionals in the world. Directly or indirectly, you'll have exposure to cutting-edge technology and groundbreaking medical research.


