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2 Syneos Health Senior Medical Writer Jobs
Sr Medical Writer - (CSR, ICF) Regulatory
5-8 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Sr Medical Writer - (CSR, ICF) Regulatory
Syneos Health
posted 8d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Act as lead for assigned medical writing projects independently managing the end-to-end development of regulatory documents, with minimal oversight.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Interact with internal and external stakeholders regarding projects--participate in meetings and presentations to the client, independently lead and conduct KOMs and review meetings with the study teams.
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Develops or supports a variety of documents that include, but not limited to: o Clinical study protocols and clinical protocol amendments;
o Clinical study reports;
o Informed consent forms and Assent forms
o Patient narratives;
o IND submissions and annual reports;
o Investigator brochures, IB Updates.
- 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%).
Qualifications
What we re looking for
- 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.
- 5+ years of experience as a medical writer or other relevant work experience.
- Experience in CSR, protocol, IB, informed consent, and clinical summaries and clinical overviews
- 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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(based on 33 Syneos Health interviews)
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Company Website
46%
21%
21%
12% candidates got the interview through other sources.
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What Senior Medical Writer at Syneos Health are saying
Rating based on 7 Senior Medical Writer
reviews
Anonymous · Pharmaceutical & Biotechnology
in Gurugram
Likes
Work environment and company culture
Dislikes
Progress in career is slow
Read 7 reviewsSenior Medical Writer salary at Syneos Health
reported by
34
employees
with 6-10
years exp.
₹7.8
L/yr - ₹16.7
L/yr
25%
more
than the average Senior Medical Writer Salary in India
View more details
What Syneos Health employees are saying about work life
based on 556 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Syneos Health Benefits
Submitted by Company
Financial Health Learning, Development and Growth Physical Health Employee Resources
Submitted by Employees
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Sr Medical Writer - (CSR, ICF) Regulatory
5-8 Yrs
Kolkata, Mumbai, New Delhi +4 more
Sr Medical Writer - (Process Mapping , Scientific Writer)
1-4 Yrs
Kolkata, Mumbai, New Delhi +4 more
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