Senior Medical Writer, Clinpharm – CSR, IB, Protocol
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Leads the resolution of comments from the client.
- Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
- Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
- Coordinates quality and editorial reviews.
- Ensures source documentation is managed appropriately.
- Leads team document reviews, and reviews documents as needed.
- Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Provides feedback to further define statistical output required and document needs.
- Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
- Performs online clinical literature searches and complies with copyright requirements.
- Identifies and proposes solutions to resolve issues, escalating as appropriate.
- Provides technical support, training, and consultation to department and other company staff.
- May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities.
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
- Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
- Completes required administrative tasks within the specified timeframes.
- Performs other work-related duties as assigned.
Requirements
- 3-5 years of relevant experience in science, technical, or medical writing.
- Experience working in the biopharmaceutical, device, or contract research organization industry required.
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
- Experience writing relevant document types required.
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.
Benefits
- Health insurance
- Professional development opportunities
- Total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingclinical study protocolsclinical study reportspatient narrativesIND submissionsNDA submissionseCTD submissionsstatistical analysis planstechnical supportliterature searches
Soft skills
communicationteam leadershipmentoringproblem-solvinginterpersonal skillsattention to detailorganizational skillstime managementcollaborationfeedback provision