job title: senior medical writer(syneos)

Job responsibilities

• 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, as well as;

  • 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%).

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.

• 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.