Senior Medical Writer

Medical writerMedical writerFull TimeRemoteSeniorTeam 10,001+Since 1988H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

10 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Medical Writer

Regeneron

• Author clinical study reports (CSRs), protocols, informed consent forms (ICFs), narratives, investigator brochures, and other regulatory documents across therapeutic areas • Represent Medical Writing at meetings, drive document development, and articulate strategy and timelines • Identify the right parties for content decisions and synthesise discussions into clear, accurate prose • Review work of junior or outsourced writers and CSR-related documents like Statistical Analysis Plans and TFLs • Write plain-language content such as ICFs and explain complex medical concepts to lay audiences • Adhere to applicable guidelines, templates, SOPs, and internal training while contributing to process improvement across Medical Writing and Global Development • Mentor junior staff, manage multiple priorities, and foster collaboration to resolve conflict

Job Requirements

  • Bachelor's degree required; advanced degree preferred
  • Minimum 3 years of medical writing experience, including working knowledge of biostatistics
  • Strong knowledge of the clinical research process and applicable regulations, including ICH GCP
  • Clinical document reading, writing, and editing experience
  • Strong knowledge of MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems
  • Ability to manage multiple projects with strong organisational, interpersonal, and communication skills

Benefits

  • annual bonuses or other incentive plans
  • equity awards
  • pension or retirement benefits
  • 401(k) company match
  • health and wellness programs
  • fitness centers
  • insurance benefits (e.g. medical, dental, vision, life and disability)
  • paid time off
  • family support benefits

Related Categories

Related Job Pages

More Medical writer Jobs

Praxis Precision Medicines, Inc. logo

Medical Writer

Praxis Precision Medicines, Inc.

The era of genetic neuroscience has arrived

Medical writer11 days ago
ContractRemoteTeam 51-200H1B No Sponsor

• Implements all activities related to the preparation of defined medical and regulatory documents • Supports documents for regulatory submissions to US and global health authorities • Collaborates with cross-functional team members to ensure accurate and timely completion and delivery of high-quality documents • Supports clinical trial transparency and disclosures • Contributes to departmental development through editorial and review support for document templates

United States
Full TimeRemoteTeam 10,001+Since 1956H1B Sponsor

• Serve as a primary writer who creates and provides input on routine deliverables, such as medical information documents, publications and clinical study documents • Develop complex medical and scientific documents, including AMCP dossiers, infographics, slide presentations, manuscripts, study documents for complex programs • Review documents prepared by team members • May provide training and mentorship for medical writers and new hires • Ensure compliance with applicable SOPs, WI, quality processes, and requirements for documents • Provide input on and independently develop best practices for achieving optimal results, including various client-specific processes • May function as a project lead or assist with program management activities. Duties could include developing timelines, budgets, forecasts, and contract modifications; tracking deliverable metrics; and representing medical writing team in client meetings

North Carolina
Mercor logo

Registered Nurse - Clinical Documentation

Mercor

Cincinnatus is an enterprise staffing company that partners with leading technology companies to source and employ highly skilled professionals for full-time and long-term contingent roles. Cincinnatus serves as the employer of record for these engagements, providing W-2 employment, payroll, benefits, and compliance, while placing employees directly within client teams to work on high-impact initiatives. Roles hired through Cincinnatus are not project-based or freelance engagements. They are structured, role-based positions that typically involve full-time or fixed-term commitments, close collaboration with a client's internal teams, and integration into standard enterprise workflows. Cincinnatus is a legal entity separate from Mercor. While opportunities may be discovered through Mercor's platform, employment, onboarding, payroll, and benefits for these roles are administered by Cincinnatus. Equal Employment Opportunity Cincinnatus is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or any other legally protected characteristic. Cincinnatus is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans throughout the job application process.

Medical writer11 days ago
Part TimeRemoteH1B No Sponsor

Role Description - Review and assess clinical documentation for accuracy, completeness, and quality. - Analyze healthcare workflows and recommend process improvements. - Interpret patient records and clinical notes to support product development. - Identify documentation gaps, inconsistencies, and edge cases. - Collaborate with product, engineering, and operations teams to refine AI-driven healthcare tools. - Ensure adherence to healthcare regulations, policies, and best practices. Qualifications - Active Registered Nurse (RN) license. - 3–5+ years of clinical nursing experience. - Strong understanding of clinical documentation and healthcare workflows. - Experience working with EHR systems (Epic, Cerner, Meditech, etc.). - Excellent analytical, communication, and problem-solving skills. - Preferred: Experience in CDI, case management, utilization review, or quality improvement. - Preferred: Exposure to healthcare technology, AI tools, or digital health products. - Preferred: Ability to collaborate effectively with cross-functional teams. Company Description Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam D'Angelo, Larry Summers, and Jack Dorsey.

Worldwide
$60 - $80 / hour
Mercor logo

Clinical Documentation Integrity Leader

Mercor

Cincinnatus is an enterprise staffing company that partners with leading technology companies to source and employ highly skilled professionals for full-time and long-term contingent roles. Cincinnatus serves as the employer of record for these engagements, providing W-2 employment, payroll, benefits, and compliance, while placing employees directly within client teams to work on high-impact initiatives. Roles hired through Cincinnatus are not project-based or freelance engagements. They are structured, role-based positions that typically involve full-time or fixed-term commitments, close collaboration with a client's internal teams, and integration into standard enterprise workflows. Cincinnatus is a legal entity separate from Mercor. While opportunities may be discovered through Mercor's platform, employment, onboarding, payroll, and benefits for these roles are administered by Cincinnatus. Equal Employment Opportunity Cincinnatus is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or any other legally protected characteristic. Cincinnatus is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans throughout the job application process.

Medical writer11 days ago
Part TimeRemoteH1B No Sponsor

Role Description Lead clinical documentation integrity programs for inpatient and outpatient settings. Oversee concurrent and retrospective review workflows. - Evaluate AI-generated clinical documentation improvement suggestions, physician queries, and coding recommendations. - Ensure clinical accuracy and compliance. - Conduct and review clinical documentation. - Ensure accurate capture of diagnoses, procedures, severity of illness, and risk of mortality. - Develop and manage physician query processes. - Align with AHIMA and ACDIS guidelines. - Monitor CDI program KPIs including query response rates, CC/MCC capture rates, case mix index, and DRG accuracy. - Collaborate with coding, compliance, and clinical teams. - Address documentation gaps and improve query processes. Qualifications - 5+ years of experience in clinical documentation integrity or improvement. - At least 2 years in a manager or leadership role. - Deep knowledge of MS-DRG methodology, CC/MCC hierarchies, and ICD-10-CM/PCS coding guidelines. - Expertise in physician query management per AHIMA and ACDIS compliant query standards. - Strong clinical background with the ability to interpret medical records and clinical documentation. - Proficiency with CDI software platforms (3M, Nuance, Optum360, or equivalent) and EHR systems. - Exceptional written and verbal English communication skills. - High attention to detail with the ability to critically evaluate clinical documentation and AI-generated outputs. - Comfortable working independently in a fully remote environment. Requirements - CCDS (Certified Clinical Documentation Specialist) or CDIP (Clinical Documentation Improvement Practitioner) credential preferred. - Experience with HCC risk adjustment and outpatient CDI programs. - Background in RN, RHIA, CCS, or similar clinical or coding credential. - Familiarity with AI-assisted CDI tools (e.g., Nuance DAX, 3M M*Modal) and comfort evaluating AI-generated clinical content. - Experience presenting CDI performance metrics to clinical and executive leadership. Application Process - Upload resume - AI interview based on your resume - Submit form Resources & Support - For details about the interview process and platform information, please check: https://talent.docs.mercor.com/welcome - For any help or support, reach out to: support@mercor.com - Our team reviews applications daily. Please complete your AI interview and application steps to be considered for this opportunity.

United States
$84 / hour