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Sr Medical Writer - (Process Mapping , Scientific Writer)
1-4 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Sr Medical Writer - (Process Mapping , Scientific Writer)
Syneos Health
posted 10hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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.
- Compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc., and serves as a medical writer within and across departments with minimal supervision.
- Ability to create process maps from provided technical material or from client inputs. Hands on experience of using MS Visio or similar tools.
- 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 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.
- 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.
- Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
- 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.
Employment Type: Full Time, Permanent
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Rating based on 7 Senior Medical Writer
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Anonymous · Pharmaceutical & Biotechnology
in Gurugram
Work environment and company culture
Progress in career is slow
Read 7 reviewsSenior Medical Writer salary at Syneos Health
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