Senior Medical Writer
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Medical Writer creating clinical and regulatory documents for Syneos Health’s life sciences research services. Coordinating reviews, regulatory compliance, and cross-functional study deliverables.
Responsibilities:
- Lead clear and accurate completion of medical writing deliverables
- Manage medical writing activities for individual studies and coordinate across departments
- Lead resolution of client comments
- Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
- Follow ICH E3 guidelines, company SOPs, client standards, templates, authorship requirements, and style guides
- Coordinate quality and editorial reviews and manage source documentation
- Lead team document reviews and perform peer reviews
- Review statistical analysis plans and table/figure/listing specifications
- Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
- Perform online clinical literature searches and comply with copyright requirements
- Identify and resolve issues, escalating as appropriate
- Provide technical support, training, and consultation
- Contribute to internal materials, presentations, processes, standards, and capabilities
- Mentor and lead less experienced medical writers on complex projects
- Develop expertise in industry topics and regulatory requirements
- Complete administrative tasks and other assigned duties
Requirements:
- Minimum 4 to 5 years of experience in medical writing
- 3–5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry
- Experience working with PK/PD studies, CSR, IB, ICF, and protocols
- Experience with Phase II/Phase III studies and readiness to work in Early Phase
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
- Experience writing relevant document types
- Extensive knowledge of English grammar and ability to communicate clearly
- Strong familiarity with AMA Manual of Style
- Ability to work within budgeted hours and communicate status and changes to medical writing leadership
- Equivalent experience, skills, and/or education will also be considered
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Minimal travel may be required (less than 25%)
Similar Jobs
Medical Copywriter
Medical copywriter translating complex pharmaceutical science into promotional content. Developing compliant campaigns for HCPs, patients, and global healthcare brands at Greenpark.
Senior Medical Copywriter
Senior Medical Copywriter creating HCP campaigns and medical education content for Orchard, a medical communications agency. Translating complex science into accurate, FDA-compliant copy for US pharmaceutical clients.
Sponsor Dedicated Protocol Medical Writer II/Sr
Medical Writer developing clinical protocols and regulatory documents for Syneos Health’s life sciences clients. Partnering with Clinical Scientists across oncology, hematology, and cell therapy studies.
Senior Clinical Documentation Improvement Specialist
Senior CDI Specialist improving inpatient medical-record documentation integrity at Mercy. Reviewing records, educating providers, and supporting healthcare quality and compliance initiatives.
RN – Clinical Documentation Integrity Specialist
RN CDI Specialist reviewing inpatient records, clarifying diagnoses, and supporting DRG accuracy for Carle Health. Educating clinicians and contributing to coding, quality, and compliance initiatives.
Clinical Documentation Specialist
Clinical Documentation Specialist reviewing inpatient records for MercyOne Genesis healthcare. Ensuring accurate clinical severity, mortality risk, quality indicators, and service-level documentation.
Clinical Documentation Specialist
Clinical Documentation Specialist reviewing inpatient records for accuracy and completeness at MercyOne Genesis. Educating providers and querying documentation to support compliant patient-care coding.
Senior Strategic Medical Writer
Senior Strategic Medical Writer leading clinical and regulatory documentation for AbbVie’s drug and device development. Coordinating reviews, quality control, submission strategies, and inspection-ready responses.
Medical Writer
Medical Writer developing clinical trial documents for Emerald Clinical Trials, a global clinical research company. Drafting protocols, CSRs, regulatory submissions, and scientific manuscripts.
Medical Writer – Senior Medical Writer
Medical Writer leading complex clinical and regulatory documentation for Emerald Clinical Trials. Supporting drug development and clinical research across global pharmaceutical and biotech programs.
Clinical Documentation Integrity Analyst
Clinical Documentation Integrity Analyst reviewing hospital records, physician queries, and coding opportunities. Training CDI specialists and improving documentation accuracy, compliance, and quality outcomes at University Hospitals.
Medical Writer
Medical Writer producing clinical study reports, protocols, and regulatory documents for Thermo Fisher Scientific. Supporting pharmaceutical and CRO clients through scientific writing and project coordination.
Clinical Documentation Integrity Specialist
Remote Clinical Documentation Integrity Specialist improving inpatient documentation for accurate coding and reimbursement. Reviewing charts, clarifying records with providers, and supporting healthcare data quality at Med-Metrix.
Clinical Documentation Improvement Specialist
Clinical Documentation Improvement Specialist enhancing coding accuracy, provider education, and risk adjustment for a mission-driven community healthcare organization. Fully remote within the United States.
Principal Medical Writer
Principal Medical Writer leading regulatory and clinical documents for ICON, a global healthcare intelligence and clinical research organization. Guiding submissions for new biologics and drugs.
Medical Writer II
Medical Writer developing clinical trial documents, regulatory submissions, and scientific publications for ICON, a global healthcare research organization. Supporting clinical data interpretation and cross-functional study teams.
Senior Strategic Medical Writer
Senior Medical Writer developing clinical and regulatory documents for AbbVie’s innovative medicines and devices. Coordinating reviews, quality control, submissions, and inspection-ready responses.
RN – Clinical Documentation and Compliance Specialist
Clinical Documentation and Compliance Specialist improving inpatient records and coding accuracy. Supporting Presbyterian’s New Mexico hospitals, physicians, and HIM coding teams.
RN – Clinical Documentation and Compliance Specialist
Clinical documentation specialist reviewing inpatient records, diagnoses, and billing requirements. Supporting Presbyterian Healthcare Services, New Mexico's nonprofit hospital and health-plan system.
Manager, Clinical Documentation Integrity – CDI
CDI Manager leading documentation integrity, HCC coding, and audit readiness. Improving clinical workflows and physician support for Greenbrook Medical’s senior primary-care platform.