Medical writer

• Develop and maintain scientific lexicon and platforms for assigned products
• Partner with subject matter experts to develop and manage scientific content for global conferences
• Lead the development of abstracts, posters, slide decks, manuscripts, and educational materials
• Collaborate with clinical development, regulatory affairs, and other stakeholders
• Review and revise documents based on feedback
• Maintain high-quality standards for all scientific documentation
• Stay current with relevant scientific literature and regulatory guidelines

Medical Writer – Scientific Communications

• Prepare and deliver high-quality, scientifically accurate, and regulatory-compliant clinical/medical documentation
• Collaborate with cross-functional teams
• Author clinical/regulatory documents, including protocols, CSRs, IBs, and clinical modules for INDs/CTAs, NDAs/MAAs
• Participate in document reviews and revisions
• Manage document preparation within established timelines

Medical Writer – Clinical Regulatory Documentation

• Perform concurrent and retrospective review of the medical record
• Educate clinicians to ensure the documentation accurately reflects the condition(s) and treatment(s) of the patient
• Respond to coding queries and contribute to the development and training of coding staff
• Communicate and educate providers concerning accurate clinical documentation
• Collaborate with healthcare professionals to ensure accurate documentation in the medical record
• Educate Emergency Medicine providers regarding clinical documentation improvement
• Partner with coding professionals to ensure accuracy of diagnostic and procedural data
• Review/audit of medical records to determine correct coding and corrective action plans
• Provide ongoing training including coding updates and refresher topics
• Address client issues/questions regarding coding
• Assist in new client start-ups from a coding documentation perspective
• Perform special audits as requested
• Work as an involved team member with the goal of achieving excellent coding accuracy

Clinical Documentation Manager

• Conduct reviews of inpatient medical records
• Identify missing, vague, and/or incomplete components
• Communicate the need for additional documentation to clinical providers
• Collaborate with other departments to improve documentation quality
• Provide data reports and educational support for documentation elements
• Support initiatives to improve documentation quality by caregivers

Senior Clinical Documentation Improvement Specialist – Exempt

• Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
• Completes required administrative tasks within the specified timeframes
• Performs online clinical literature searches and complies with copyright requirements
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing
• Minimal travel may be required (less than 25%)

Senior Medical Writer – Regulatory

• Function as a liaison between clinicians and coders
• Work as an expert source for information regarding the impact of documentation on patient care, quality outcomes measures, risk of mortality/severity of illness indicators, and accurate reimbursement
• Work under the direction of the Clinical Documentation Integrity Supervisor, conduct concurrent review of inpatient medical records-seeking clarification of documentation before the patient is discharged

RN – Clinical Documentation Integrity Specialist

• The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development.
• Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards.
• Works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.

Principal Medical Writer

• Demonstrate understanding for multiple products and disease states
• Interact with internal teams (Account, PM, creative, etc.) and clients on programs to meet strategic objectives.
• Work closely with the Associate Medical Director in managing multiple accounts from a scientific perspective including all scientific and strategic aspects of medical communication tactics, meetings, and programs
• Participate in strategic planning and project meetings with internal and client teams as needed
• Self-educate on innovation in the industry and begin to conceptualize programs for teams
• Develop depth of understanding for assigned products, related medical areas, and competitors on an ongoing basis
• Identify and communicate important updates and medical-regulatory milestones to the team and recommend new business opportunities
• Collaborate with the Editorial team to resolve grammatical or stylistic errors or concerns
• Take a proactive solutions-oriented approach into all assignments

Senior Medical Copywriter

• Facilitating the improvement in the overall quality and completeness of provider-based clinical documentation in the medical record
• Assisting treating providers to ensure documentation accurately reflects diagnostic-related group, severity of illness, risk of mortality, risk adjustment, and complexity of patient care rendered
• Conducting accurate and timely concurrent record reviews
• Ensuring data integrity of the clinical documentation database
• Educating customers through presentations and reports on documentation opportunities

RN Clinical Documentation Specialist

• Write multiple focused needs assessments/grants weekly (~3-4 per week) creating supportive literature reviews and suggesting and/or refining themes, learning objectives, and agendas
• Work with faculty, VP of Educational Development, and CMO to help define the educational need
• Utilize quotes and outcomes as need to support the educational need
• Coordinate and review and finalize, grant submission sections according to supporters’ grant portal requirements, including grant summaries, letters of request, etc
• Assist in preparation of grant template documents for upcoming grant development needs and manage all grant templates
• Identify Request for Proposals (RFPs) or Call for Grant Applications (CGAs) within the dermatology space
• Maintain supporter and grant status reports
• Collaborate with CME accrediting bodies though relevant stages of the process
• Analyze activity outcomes data to identify educational uptake and unmet educational needs and gaps
• Work closely with the grants manager/coordinator to assist in the submission of proposals
• Maintain timelines for all grant submission ensuring all are submitted on time and within scope

Medical Grant Writer

• Perform concurrent inpatient documentation reviews to identify opportunities for improved documentation specificity, clinical validation, and coding accuracy.
• Conduct compliant physician queries following AHIMA/ACDIS guidance to clarify conflicting, incomplete, or ambiguous documentation.
• Support accurate ICD-10-CM/PCS coding, MS-DRG/APR-DRG assignment, POA indicators, CC/MCC capture, SOI/ROM, PSIs, HACs, and quality metrics.
• Perform clinical validation reviews for high-impact diagnoses including sepsis, acute respiratory failure, AKI, encephalopathy, malnutrition, and other complex conditions.
• Collaborate with coding, CDI, quality, and physician teams to improve documentation quality and reduce denials.
• Provide physician and CDI education based on documentation trends and audit findings.
• Monitor productivity, quality, and compliance standards while participating in internal audits and continuous improvement initiatives.
• Maintain current knowledge of CMS regulations, ICD-10-CM/PCS, Coding Clinic, AHIMA, and ACDIS guidance.

Clinical Documentation Integrity Specialist – FT

• Develop regulatory documents for submission to regulatory agencies globally
• Manage medical writing projects, including timelines and communication
• Participate in cross-functional meetings to provide input regarding deliverables
• Review other documents associated with assigned projects as appropriate

Senior Principal Regulatory Medical Writer – Oncology Preferred

• Collaborates with physician, mid-level providers, ancillary staff, and medical records coders to identify principle and secondary diagnoses, and principle procedures
• Reviews for quality indicators
• Conducts initial and ongoing concurrent and some retrospective reviews for system wide admissions for all payors
• Identifies when there is a need to clarify documentation in patient records and initiates queries or communication with providers
• Provides information and education as necessary to providers on an ongoing basis
• Collaborates with Physician Advisor to present education

Clinical Documentation Specialist

• Partner and collaborate with clinical and regulatory team members in the preparation of clinical protocols and regulatory documents; participate in study results interpretations and manage the document review/approval process to capture comments and resolve conflicts, including running round-table meetings.
• Communicate and coordinate with line-function team members to gather, organize, and compile information towards the development and planning of writing scientific, clinical, and regulatory documents; communicate deliverables needed, writing process and timelines, and hold team members accountable to agreed-upon dates for deliverables.
• Contribute to timeline planning for regulatory and clinical documents authored by Medical Writing.
• Contribute to preparing manuscripts, conference publications, and slides on research discovery results to support Disc publication strategy.
• Perform QC review as Medical Writing line-function representative and for documents written by other Medical Writing team members.
• Ensure applicable guidelines and regulations are followed in the scientific and clinical writing deliverables, including but not limited to the International Conference on Harmonization (ICH), electronic Common Technical Documents (eCTD) guidelines, content, and templates, as well as document-appropriate QC.
• Verify and share literature references to online library, gather and post literature for submissions, search, and order articles as needed.
• Assist with template modification or creation.
• Stay up to date on current industry practices, compliances, regulations, and company standard operating procedures and policies; assist with writing Medical Writing work instructions, guides, and policies.

Medical Writer

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision.
• Leads team document reviews and reviews documents for technical issues.
• Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

• 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

Senior Medical Writer

• Independently plans and prepares a range of regulatory documents and/or medical communications to support all phases of product development.
• Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with industry guidelines.

Principal Medical Writer – MedPubs Focus

• Improve overall quality and completeness of clinical documentation
• Facilitate modifications to clinical documentation through interaction with medical staff
• Educate patient care team members on documentation
• Conduct on-going follow-up reviews for documentation compliance
• Collaborate with coding staff to assign working DRG

Registered Nurse, Clinical Documentation Specialist – CDIP, CCDS Required

• Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations
• Lead the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity
• Collaborate with cross-functional teams to gather and synthesize information for document development
• Provide guidance on best practices for medical writing and ensure adherence to regulatory requirements and internal standards
• Mentor and train junior medical writers, fostering a culture of excellence and professional growth
• Stay current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs
• Act as a lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs

• Serving as medical point person on assigned accounts
• Developing, writing and translating complex scientific data to a broad audience across multiple and wide-ranging therapeutic areas
• Ensuring project quality and outcomes by demonstrating in depth technical expertise of assigned therapeutic category and/or managed care areas
• Developing strategic content for full range of medical content (slide presentations, advisory boards, strategy guides, monographs, discussion guides, training resources, etc.)
• Working closely with account teams to refine content in keeping with strategic imperatives
• Communicating medical content with internal team and pharmaceutical clients, as necessary
• Attending medical, legal, regulatory review meetings
• Participating in internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings
• Chipping in ideas for new business proposals and tactical planning within assigned accounts
• Mentoring junior level writers

Medical writer jobs in United States

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Medical Writer – Scientific Communications

Medical Writer – Clinical Regulatory Documentation

Clinical Documentation Manager

Senior Clinical Documentation Improvement Specialist – Exempt

Senior Medical Writer – Regulatory

RN – Clinical Documentation Integrity Specialist

Principal Medical Writer

Senior Medical Copywriter

RN Clinical Documentation Specialist

Medical Grant Writer

Clinical Documentation Integrity Specialist – FT

Senior Principal Regulatory Medical Writer – Oncology Preferred

Clinical Documentation Specialist

Medical Writer

Principal Medical Writer

Senior Medical Writer

Principal Medical Writer – MedPubs Focus

Registered Nurse, Clinical Documentation Specialist – CDIP, CCDS Required

Principal Medical Writer

Senior Scientific Associate – Senior Medical Writer, Promotional Medical Writing