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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 10hr 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;
- 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.
- 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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Anonymous · Pharmaceutical & Biotechnology
in Gurugram
Work environment and company culture
Progress in career is slow
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