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1 Syneos Health Senior Medical Writer Job
Sr Medical Writer - Regulatory
2-6 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Sr Medical Writer - Regulatory
Syneos Health
posted 6hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Senior Medical Writer - Regulatory
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
Job responsibilities
- 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.
Get to know Syneos Health
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.
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.
No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health .
Employment Type: Full Time, Permanent
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What Senior Medical Writer at Syneos Health are saying
Rating based on 6 Senior Medical Writer
reviews
Anonymous · Pharmaceutical & Biotechnology
in Gurugram
Likes
Work environment and company culture
Dislikes
Progress in career is slow
Read 6 reviewsSenior Medical Writer salary at Syneos Health
reported by
35
employees
with 6-10
years exp.
₹7.8
L/yr - ₹16.7
L/yr
27%
more
than the average Senior Medical Writer Salary in India
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What Syneos Health employees are saying about work life
based on 551 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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