Principal Medical Writer – Publications
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Arizona • Maine • United States
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Job Level
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
- 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
- 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
- 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.
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
- We are passionate about developing our people, through career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingclinical study protocolsclinical study reportsinformed consentsNDA submissionseCTD submissionsstatistical analysis planstechnical supportliterature searchesdocument reviews
Soft Skills
communicationteam leadershipmentoringproblem-solvingcollaborationattention to detailorganizational skillsfeedback provisioninterpersonal skillsclarity in writing