Everest Clinical Research logo
Everest Clinical Research

Quality is Our Backbone. Customer-focus is Our Tradition. Flexibility is Our Strength.

Medical Writer

Medical writerMedical writerFull TimeRemoteMid LevelTeam 501-1,000Since 2004H1B SponsorCompany SiteLinkedIn

Location

Canada

Posted

15 days ago

Salary

C$65K - C$100K / year

Seniority

Mid Level

No structured requirement data.

Job Description

Medical Writer

Everest Clinical Research

Role Description To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Medical Writer for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. - Work closely with the Everest project team members assigned to the project to achieve project milestones according to the project timeline. - Perform Everest internal QC procedures for clinical documents developed by other Medical Writers, such as: - Clinical study protocols - Clinical Study Reports (CSRs; full, abbreviated, or synoptic) - Pharmacokinetic (PK) reports - Statistical reports - Integrated efficacy or safety summaries - Patient narratives - Manuscripts, posters, and abstracts - Apply therapeutic area experience and scientific knowledge in the review and include QC checks for: - Protocol-related information - Accuracy of in-text numbers and source references - Consistency of document styles and formats - Act as a lead medical writer in the preparation of clinical documents or scientific publications. - Perform literature searches to support senior medical writers. - Perform document e-publishing for CSRs and other clinical/regulatory documents. - Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements. - Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH. - Plan and carry out professional development. Qualifications - Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter. - At least two years' experience in medical writing practice, with experience in the pharmaceutical clinical trial environment. - Experience with medical writing for clinical study reports for regulatory submission (preferred). - Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset (preferred). - Excellent understanding of clinical trials and common clinical trial statistical analysis methods (preferred). - Demonstrated ability to understand medical information and results; able to communicate effectively, orally and in writing. - Ability to handle multiple projects and clients. - Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused. - Demonstrated experience, knowledge, and understanding of GCP/ICH guidelines, including E3 Structure and Content of Clinical Study Reports. - Well organized and able to work independently. - Comprehensive skills in Microsoft Office applications and Adobe Acrobat. Computing skills with TRS Toolbox pharma edition plugin an asset. Requirements - Strong foundation in statistical and data management. - Ability to perform effective editing on assigned medical writing products. - Experience in performing QC checks on medical writing deliverables. - Ability to incorporate reviewers’ comments/input into draft documents. - Experience in finalizing documents for delivery to Sponsors according to established timelines. Benefits - Robust benefits package including medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus.

Related Categories

Related Job Pages

More Medical writer Jobs

Full TimeRemoteTeam 1-10Since 2001H1B No Sponsor

• Review and evaluate medical record documentation for completeness, accuracy, and compliance. • Collaborate with physicians, nurses, and coding professionals to ensure appropriate clinical documentation. • Identify opportunities for documentation improvement to support coding accuracy, reimbursement, and clinical outcomes. • Analyze medical records to ensure documentation supports quality care and appropriate reimbursement. • Formulate compliant, clinically sound physician queries.

United States
R1 RCM logo

Clinical Documentation Improvement Specialist

R1 RCM

Technology-driven revenue cycle management services for healthcare providers.

Medical writer16 days ago
Full TimeRemoteTeam 10,001+Since 2017H1B Sponsor

• Use clinical and coding knowledge for conducting clinically based concurrent and retrospective reviews of inpatient medical records • Evaluate the documentation of clinical services by identifying opportunities for improving the quality of medical record documentation • Facilitate and obtain appropriate physician documentation for clinical conditions or procedures • Participate in ongoing documentation improvement initiatives

United States
$48.1K - $81.2K / year
Job Closed
Mass General Brigham logo

Clinical Documentation Specialist

Mass General Brigham

Mass General Brigham connects a full spectrum of care across a system of academic medical centers, specialty and community hospitals, physician networks, a heal

Medical writer16 days ago

Role Description We are seeking a per diem Clinical Documentation Specialist to join the Utilization Management department supporting Mass General Brigham Home Care. The Clinical Documentation Improvement (CDI) Specialist is responsible for enhancing the accuracy, completeness, and quality of clinical documentation to support appropriate reimbursement, quality care initiatives, and compliance with regulatory requirements. - Review patient medical records to ensure clinical documentation is accurate, complete, and compliant with established documentation standards. - Collaborate with physicians, nurses, and other healthcare professionals to clarify documentation and obtain information necessary to support accurate coding and billing. - Provide guidance to coding staff on documentation requirements that support accurate code assignment, regulatory compliance, and appropriate reimbursement. - Identify documentation gaps, trends, and opportunities for improvement, and develop strategies to enhance documentation quality and consistency. - Educate clinical staff on documentation best practices, regulatory requirements, and the impact of documentation on patient care, quality reporting, and reimbursement. - Ensure clinical documentation complies with applicable regulatory standards, including CMS guidelines, HIPAA regulations, and other healthcare requirements. - Analyze documentation quality and compliance data, prepare reports, and recommend process improvements to strengthen documentation practices. - Partner with interdisciplinary teams to ensure documentation accurately reflects the patient's clinical condition, care provided, and treatment outcomes. Qualifications - Bachelor's Degree Nursing required or Master's Degree Nursing preferred - Registered Nurse [RN - State License] - Massachusetts Licensure - COS-C Certified - Required - HCS-D - Certified - Required - Clinical nursing experience 2-3 years required - Clinical documentation experience 1-2 years preferred Requirements - No experience in lieu of a degree accepted Benefits - Competitive base pay - Comprehensive benefits - Career advancement opportunities - Differentials, premiums, and bonuses as applicable - Recognition programs designed to celebrate contributions and support professional growth Company Description Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

United States
$79.6K - $115.7K / year
Job Closed
Trinity Health logo

Clinical Documentation Specialist Audit Coordinator

Trinity Health

We are one of the largest not-for-profit, faith-based health care systems in the nation.

Medical writer16 days ago
Full TimeRemoteTeam 10,001+H1B Sponsor

Title: Clinical Documentation Specialist Audit Coordinator (Remote) Location: Livonia MI United States Job Description: Employment Type: Full time Shift: Day Shift Description: POSITION PURPOSE Work Remote Position (Pay Range: $41.4306-$62.1459) Provides onsite and remote clinical documentation integrity (CDI) support to the Health Ministry (HM) CDI programs as part of the System Office CDI Float Pool. Utilizes advanced coding and/or clinical expertise to direct efforts toward the improvement and integrity of clinical documentation. Responsible for reviewing and/or auditing medical record clinical documentation to support the medical necessity, severity of illness, risk of mortality, accurate coding, clinical evidence, resources consumed, and level of services rendered to all patients. Audits HM CDSs for query compliance, workflow and missed documentation opportunities. Trains end users in the use of CDI system software, standards, and workflow. ESSENTIAL FUNCTIONS Knows, understands, incorporates, and demonstrates Trinity Health's Mission, Vision, and Values in behaviors, practices, and decisions. Demonstrates understanding of and facilitates appropriate clinical documentation, to ensure that the medical necessity, severity of illness, risk of mortality, accurate coding, clinical evidence, resources consumed, and level of services provided are accurately reflected in the health record. Conducts clinical documentation chart reviews and queries providers as appropriate to support RHMs staffing needs. Reviews may be conducted on site or remotely. Follows HM CDI Program workflow and processes and communicates with local CDI Team to support local operations. Communicates with physicians and other members of the healthcare team at the HM regarding clinical documentation as part of local CDI Team assignment. Audits medical records, queries, CDS and coder assigned codes, CDI software entries, etc., as requested to provide feedback to the HMs for improvement opportunities. Trains end users in the use of CDI system software, standards, and workflow. Provides documentation education to providers and members of healthcare team at the RHM as part of CDI Team assignment or as requested. Demonstrates ability to quickly learn and master the various CDI technology applications, systems and workflows in place across the enterprise. Provides expertise in problem-solving skills based on theoretical knowledge, clinical experience and sound judgment and serves as a professional role model by demonstrating desirable practice behaviors. Assists the System Office Clinical Documentation Manager with all aspects of the CDI program across the system including data collection and maintenance of the CDI Dashboard. May develop educational content for providers and CDSs on CDI workflow and processes, CDI and Physician software systems, and documentation and coding guidelines as requested. Performs other duties as assigned by leadership. Maintains a working knowledge of applicable Federal, State and local laws and regulations, accrediting agencies, Trinity Health's Organizational Integrity Program, Standards of Conduct, Code of Ethics, as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical and professional behavior. MINIMUM QUALIFICATIONS Must possess a minimum of one of the below: - Current Registered Nurse License, - Registered Health Information Administrator (RHIA), - Registered Health Information Technician (RHIT), - Certified Coding Specialist (CCS) Certification as a Clinical Documentation Specialist (CCDS) or Certified Documentation Improvement Professional (CDIP) preferred. Experience in Clinical Documentation Integrity. Excellent communication (verbal and written), interpersonal, collaboration and relationship-building skills. Strong critical thinking skills and ability to integrate knowledge. Prioritization and organizational skills required. Ability to educate all members of the healthcare team related to clinical documentation. Experience with databases, spreadsheet software and presentation software preferred. Must be comfortable operating independently in a collaborative, shared leadership environment. Must possess a personal presence that is characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health.

Michigan
$41 - $62 / hour