Senior Medical Writer, Scientific Writer, Quality Check
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: India
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Job Level
About the role
- Serves as a senior medical writer on clinical study or regulatory or publication project teams
- Writes, edits, and coordinates content for clinical/regulatory/scientific while serving as primary technical contact with the internal team and the client
- Mentors and leads less experienced medical writers on complex projects, as necessary
- Acts as lead for assigned writing projects
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
- Develops or supports a variety of documents that include, but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations
- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables
- Serves as peer reviewer on internal review team providing review comments on draft and final documents
- Adheres to established regulatory standards, including but not limited to Journal/congress specific guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget
- Performs on-line clinical literature searches, as applicable
- Familiarity with figure-creation and data visualization software, including tools such as GraphPad Prism and Adobe Illustrator, for developing high-quality scientific figures and graphics
- Familiarity with publication planning software e.g. Datavision and PubConnect (VeevaVault Promomats)
- Reviews deliverables for scientific accuracy, data and referencing quality, appropriate style, and correct branding of scientific/medical assets
- Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing
- Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership
- Completes required administrated tasks within the specified timeframes
Requirements
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information
Benefits
- Health insurance
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- 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 documentationregulatory writingscientific writingdata visualizationstatistical analysisproofreadingpresentation skillsclinical research principlesinterpretation of clinical data
Soft skills
mentoringleadershipinterpersonal skillsteam-oriented approachindependenceproblem-solvingcommunication skillsorganizational skillsattention to detailtime management