AmbitionBox
Jobs
- Reviews
- Salaries
- Interview Questions
- About Company
- Benefits
- Jobs
- Office Photos
- Community
Add office photos
All Filters
53 Syneos Health Jobs
Sr Medical Writer /Medical Writer 2 (Clinical Trial Transparency)
6-10 years
₹ 10 - 13L/yr (AmbitionBox estimate)
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Sr Medical Writer /Medical Writer 2 (Clinical Trial Transparency)
Syneos Health
posted 1mon 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.
- Develops or supports a variety of documents that include, but not limited to:
- Clinical study protocols and clinical protocol amendments;
- Clinical study reports;
- Patient narratives;
- Clinical development plans;
- IND submissions and annual reports;
- Integrated summary reports;
- NDA and (e)CTD submissions;
- Investigator brochures, as well as;
- Clinical journal manuscripts, clinical journal abstracts, and client 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 ICH-E3 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.
- 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
Read full job descriptionPrepare for Senior Medical Writer roles with real interview advice
What people at Syneos Health are saying
Rating based on 8 Senior Medical Writer
reviews
Anonymous · Research & Development
in Gurgaon / Gurugram
Work environment and company culture
- Skill development - Good
Progress in career is slow
Senior Medical Writer salary at Syneos Health
What Syneos Health employees are saying about work life
Syneos Health Benefits
Financial Health Learning, Development and Growth Physical Health Employee Resources 
Compare Syneos Health with
IQVIA
Parexel International
ICON Plc
Fortrea Development India Private Limited
WuXi AppTec
Syngene International
Aragen Life Sciences
SAI Life Sciences
Lambda Therapeutic Research
Reliance Life Sciences
Aizant Drug Research Solutions
Veeda Clinical Research
Rubicon Research
Equinox Labs
Cliantha Research
Navitas Life Sciences
Accutest Research Laboratories
Raptim Research
Spc Life Sciences
Axis Clinicals
Similar Jobs for you
Sr Medical Writer /Medical Writer 2 (Clinical Trial Transparency)
6-10 Yrs
Kolkata, Mumbai, New Delhi +4 more
Principal / Senior Principal Stat programmer - ADAM, TLFL, SDTM
6-11 Yrs
India
Principal Stat Programmer (R Programming + Git lab)
4-7 Yrs
Kolkata, Mumbai, New Delhi +4 more
Sr Statistical Programmer(ADaM, TLF)
5-8 Yrs
Kolkata, Mumbai, New Delhi +4 more
Clinical Programmer II Professional
3-6 Yrs
Kolkata, Mumbai, New Delhi +4 more
Sr Clinical Programmer (DM SAS Expert)
5-8 Yrs
Kolkata, Mumbai, New Delhi +4 more
Statistical Programmer II (SDTM /ADAM/TFL)
3-6 Yrs
Kolkata, Mumbai, New Delhi +4 more
