Syneos Health job vacancy for Medical Writer I
Medical Writer I
Location: India-Asia Pacific – IND-Home-Based, India
Should have minimum 1 to 2 yrs relevant experience.
Must have Core CSR narrative writing experience.
Must have Authoring & QC experience of CSR narratives.
Job responsibilities:
• Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision.
• Develops or supports, a variety of documents that include but not limited to:
o Clinical study protocols and clinical study protocol amendments;
o Clinical study reports;
o Patient narratives;
o Investigator brochures.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• 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.
• Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
• Is aware 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
• Any life science background candidate with relevant writing experience and medical knowledge and expertise.
• Extensive knowledge of English grammar with a familiarity with AMA style guide.
• Understanding of FDA and ICH regulations and guidelines strongly preferred.
• Demonstrated effective presentation, proofreading, and interpersonal, 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.
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