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(1)10 NDA Jobs in Kolkata
Sr Medical Writer (CSR, IB, Protocol) |Homebased India|
6-10 years
₹ 10 - 13.2L/yr (AmbitionBox estimate)
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Sr Medical Writer (CSR, IB, Protocol) |Homebased India|
Syneos Health
posted 22d ago
Job Role Insights
Key skills for the job
Job Description
WORK HERE MATTERS EVERYWHERE
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong.
- 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
- 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.
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Employment Type: Full Time, Permanent
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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
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