Syneos Health Hiring Medical Writer I

Syneos Health Hiring Medical Writer I

23 September, 2022

Syneos Health Hiring Medical Writer I

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:
  • Clinical study protocols and clinical study protocol amendments;
  • Clinical study reports;
  • Patient narratives;
  • 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

  • MPharm qualification with relevant writing experience with relevant scientific and/or medical knowledge and expertise.
  • Must have experience in Medical writing/ Regulatory Writing/ CTD domain
  • 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.

Apply Online

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