Senior Principal Communication, Publication Strategy – CMPP Certified
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Arizona • Maine • United States
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Salary
💰 $114,000 - $210,900 per year
Job Level
About the role
- Leads the clear and accurate completion of complex medical writing deliverables.
- Completes a variety of documents including clinical study protocols and reports.
- Advises clients and study teams on data presentation and production strategies.
- Serves as expert peer reviewer for internal team, providing review comments.
- Assures adherence to established regulatory standards in all written documents.
- Interacts and builds working relationships with clients and team members.
- Identifies and proposes solutions to resolve issues, escalating as appropriate.
- Mentors and leads less experienced medical writers.
Requirements
- Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.
- 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.
- Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained.
- Leads team document reviews and reviews documents for technical issues.
- Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Interacts and builds good working relationships with clients, department head, and team members 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.
- Mentors and leads less experienced medical writers on complex documents.
- Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
- Communicates status and changes to medical writing leadership; negotiates timelines and assigned deliverables.
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
medical writingclinical study protocolsclinical study reportsdata presentation strategiespeer reviewstatistical analysis planstechnical document reviewonline clinical literature searchesIND submissionsNDA submissions
Soft Skills
leadershipmentoringcommunicationproblem-solvingrelationship buildingadvisingnegotiationteam collaborationattention to detailtime management